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In this study, 120 primary molar teeth from healthy children aged between 5 and 9 and who apply to Marmara University Faculty of Dentistry, Department of Pediatric Dentistry will be subjected to pulpotomy treatments. After proper diagnosis of coronal pulpitis, the teeth will be assigned randomly to one of the 3 groups: 40 primary molars for formocresol (FC) pulpotomy treatments, 40 primary molars for ferric sulfate (FS) treatments and 40 primary molars for 0.5% hyaluronic acid gel (HA) pulpotomy treatments. The tooth decay will be removed, the pulp will be amputated from the chamber of the pulp with a sharp excavator and one of the medicament will be applied to the orifice of the root canals. The cavity will be sealed tight with zinc oxide cement, and the primary molars will be restored with a composite filling material or with a stainless steel crown (SSC). A single investigator will perform the procedure. The teeth will be followed clinically and radiographically at 1st, 3rd, 6th, 12th months.
The aim of this study is to compare the efficacy of the materials used in pulpotomies, and to evaluate the success of hyaluronic gel over the formocresol and/or ferric sulfate considered as the gold standard for this type of treatment.
Pulpotomy is an endodontic treatment method aiming to maintain primary molar affected from deep caries and acute pulpitis by removing the effected pulpal tissue, leaving the remaining root canal pulp and maintaining its vitality and function until the tooth exfoliates physiologically. In order to remain canals intact and uninflamed various dental materials are used according to treatment purposes; categorized into three groups as devitalizing, preventive and regenerative treatment.
The ideal agent or method for pulpotomy treatment of the primary teeth has not been determined yet but the earliest method of diluted formocresol is considered by many the gold standard. Formocresol is a strong strain that fixes living tissues. It contains formaldehyde gas, organic structures, dentin channels and narrow side channels until the bacteria are also fixed. 10% formalin solution (14% formaldehyde) is used as a tissue fixative.
Ferric Sulfate an other material for pulpotomy is used in dentistry mainly as a hemostatic agent. It has several advantages over formocresol such as non-mutagenic property and keeping root canal pulp vital.
Hyaluronic acid gel, which is a new product as a pulpotomy material, has been used in dentistry as well as medicine for many years. It is distributed widely in epithelial and connective tissues. Medical uses include joint treatments, skin lotions for atopic dermatitis, cosmetic surgery etc. In dentistry, gingivitis, teething, dental surgery including implants and sinus lifting procedures and oral ulcers are main target for hyaluronic acid treatment. This study extends the use of hyaluronic acid to primary tooth endodontics.
In this study, 120 primary molar teeth from healthy children aged between 5 and 9 and who apply to Marmara University Faculty of Dentistry Department of Pediatric Dentistry will be subjected to pulpotomy treatments. Sample size calculation showed that at first 40 teeth in each group will be required to detect a significant difference (80% power, two-sided 5% significance level).
Ethical approval of the study was taken from the Clinical Research Ethics Committee, Faculty of Dentistry at Marmara University (No: 2019/288) in accordance with the Declaration of Helsinki. The patients' family will be given information about the pros and cons of the study on the relevant teeth and then a written consent will be obtained.
Patients will be selected for this study according to the following criteria:
Exclusion criteria:
After proper diagnosis of coronal pulpitis, local anesthesia is administrated, the teeth will be assigned randomly to one of the 3 groups: 40 primary molars for formocresol pulpotomy treatments, 40 primary molars for ferric sulfate treatments and 40 primary molars for 0.5% hyaluronic acid gel pulpotomy treatments. The tooth decay is removed, the roof of the pulp chamber is removed by joining the pulp horns with a bur cut. The coronal pulp is amputated from the chamber of the pulp with a sharp excavator and one or more cotton pellets is placed over the site and pressure is applied. When the hemostasis is insured, one of the medicament is applied to the orifice of the root canals. The cavity will be sealed tight with zinc oxide eugenol cement. The primary molars were restored either with a stainless-steel crown in case of proximal cavities or with a composite filling material in case of occlusal cavities. A single pediatric dentist will perform whole pulpotomy treatments and restorations of all selected teeth. The teeth will be followed clinically and radiographically at 1, 3, 6, 12 months.
The teeth will be evaluated clinically and radiographically according to the following criteria:
All evaluations will be performed by two calibrated pediatric dentists. The performing dentist will not be blinded to the treatment materials but the patient and two examiners who evaluated clinical and radiographic findings will be blinded to the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic acid | Experimental | Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar. |
|
| Formocresol | Active Comparator | 0,1 ml to the orifice of the root canals of the primary molar. |
|
| Ferric sulfate | Active Comparator | 0,1 ml to the orifice of the root canals of the primary molar. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid: Gengigel teething | Procedure | Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Teeth Sensitive to Percussion in 3 Groups | Sensitivity to biting, chewing and clinically to the percussion by a probe | Change from Baseline at 1 month in 3 groups |
| Number of Teeth Sensitive to Percussion in 3 Groups | Sensitivity to biting, chewing and clinically to the percussion by a probe | Change from Baseline at 3 months in 3 groups |
| Number of Teeth Sensitive to Percussion in 3 Groups | Sensitivity to biting, chewing and clinically to the percussion by a probe | Change from Baseline at 6 months in 3 groups |
| Number of Teeth Sensitive to Percussion in 3 Groups | Sensitivity to biting, chewing and clinically to the percussion by a probe | Change from Baseline at 12 months in 3 groups |
| Number of Mobile Teeth in 3 Groups | Mobility of the treated tooth and/or the tooth is sensitive to the vibration | Change from Baseline at 1 month in 3 groups |
| Number of Mobile Teeth in 3 Groups | Mobility of the treated tooth and/or the tooth is sensitive to the vibration | Change from Baseline at 3 month in 3 groups |
| Number of Mobile Teeth in 3 Groups | Mobility of the treated tooth and/or the tooth is sensitive to the vibration | Change from Baseline at 6 month in 3 groups |
| Measure | Description | Time Frame |
|---|---|---|
| Restoration Stability | The survival rate of stainless steel crown and composite applied to each pulpotomized tooth | Change from Baseline at 1 month |
| Restoration Stability | The survival rate of stainless steel crown and composite applied to each pulpotomized tooth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Mentes, Prof | Marmara University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University, Faculty of Dentistry, Department of Pediatric Dentistry | Istanbul | 34854 | Turkey (Türkiye) |
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The study was initially carried out on 136 primary molars of 47 children. Three children (2 boys, 1 girl) did not show up in any recalls, so the study was performed in 130 primary molars.
The first participant was enrolled in May 2019 and the last participant was enrolled in September 2019. No important changes in methods or selection criteria have been done. 1st, 3rd and 6th months assessments were made without complications but 1-year examination had some face to face problems with the Covid-19 pandemics. So some final examinations and patient comforts had been done via phone and/or online connections.
| ID | Title | Description |
|---|---|---|
| FG000 | Hyaluronic Acid | Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown and composite filling material. |
| FG001 | Formocresol | 0,1 ml to the orifice of the root canals of the primary molar. Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown and composite filling material. |
| FG002 | Ferric Sulfate | 0,1 ml to the orifice of the root canals of the primary molar. Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown and composite filling material. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
same participant can have more that 1 tooth (unit).
| ID | Title | Description |
|---|---|---|
| BG000 | Hyaluronic Acid | Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar. Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns (SSC) and composite filling material. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Teeth Sensitive to Percussion in 3 Groups | Sensitivity to biting, chewing and clinically to the percussion by a probe | Posted | Count of Units | teeth | Change from Baseline at 1 month in 3 groups | teeth | teeth |
|
Overall study;1st month,3rd month,6th month and 12th month after the treatments
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hyaluronic Acid | Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pulpitis | Infections and infestations | Non-systematic Assessment | root canals of the primary molars can be inflamed and infected so that the patient can feel the pain or discomfort during chewing. |
The limitations of this study included the unfortunate Covid-19 pandemic that interfered with the radiographic results of our study at 12th month, 8 participants did not show up to the dental appointments at 12th month and complicated the follow-up results on radiographs. However we managed to do the clinical examinations of all patients via social video conferencing devices (teledentistry).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Ali Mentes | Marmara University | +90 2164140545 | alimentes@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2019 | Feb 27, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011671 | Pulpitis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Formocresol Buckley formula: Formacresol | Procedure | Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material. |
|
| Ferric sulfate: ViscoStat | Procedure | Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material. |
|
| Number of Mobile Teeth in 3 Groups | Mobility of the treated tooth and/or the tooth is sensitive to the vibration | Change from Baseline at 12 months in 3 groups |
| Number of Teeth With Patient Discomfort and/or Pain in 3 Groups | Any pain history at that time frame and/or complaint of discomfort and pain clinically | Change from Baseline at 1 month in 3 groups |
| Number of Teeth With Patient Discomfort and/or Pain in 3 Groups | Any pain history at that time frame and/or complaint of discomfort and pain clinically | Change from Baseline at 3 months in 3 groups |
| Number of Teeth With Patient Discomfort and/or Pain in 3 Groups | Any pain history at that time frame and/or complaint of discomfort and pain clinically | Change from Baseline at 6 months in 3 groups |
| Number of Teeth With Patient Discomfort and/or Pain in 3 Groups | Any pain history at that time frame and/or complaint of discomfort and pain clinically | Change from Baseline at 12 months in 3 groups |
| Number of Teeth With Dental Abscess in 3 Groups | Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically | Change from Baseline at 1 month in 3 groups |
| Number of Teeth With Dental Abscess in 3 Groups | Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically | Change from Baseline at 3 months in 3 groups |
| Number of Teeth With Dental Abscess in 3 Groups | Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically | Change from Baseline at 6 months in 3 groups |
| Number of Teeth With Dental Abscess in 3 Groups | Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically | Change from Baseline at 12 months |
| Number of the Pathological Exfoliation of Affected Teeth in 3 Groups | The tooth is missing or ready to exfoliate physiologically and no pathology is examined | Change from Baseline at 1 month in 3 groups |
| Number of the Pathological Exfoliation of Affected Teeth in 3 Groups | The tooth is missing or ready to exfoliate physiologically and no pathology is examined | Change from Baseline at 3 months in 3 groups |
| Number of the Pathological Exfoliation of Affected Teeth in 3 Groups | The tooth is missing or ready to exfoliate physiologically and no pathology is examined | Change from Baseline at 6 months in 3 groups |
| Number of the Pathological Exfoliation of Affected Teeth in 3 Groups | The tooth is missing or ready to exfoliate physiologically and no pathology is examined | Change from Baseline at 12 months in 3 groups |
| Number of Teeth With Root Resorption in 3 Groups | Internal, external, early or physiological root resorption from periapical/panoramic radiographs | Change from Baseline at 1 month in 3 groups |
| Number of Teeth With Root Resorption in 3 Groups | Internal, external, early or physiological root resorption from periapical/panoramic radiographs | Change from Baseline at 3 months in 3 groups |
| Number of Teeth With Root Resorption in 3 Groups | Internal, external, early or physiological root resorption from periapical/panoramic radiographs | Change from Baseline at 6 months |
| Number of Teeth With Root Resorption in 3 Groups | Internal, external, early or physiological root resorption from periapical/panoramic radiographs | Change from Baseline at 12 months |
| Number of Teeth With Any Root Lesion From Radiography in 3 Groups | Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration | Change from Baseline at 1 month in 3 groups |
| Number of Teeth With Any Root Lesion From Radiography in 3 Groups | Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration | Change from Baseline at 3 months in 3 groups |
| Number of Teeth With Any Root Lesion From Radiography in 3 Groups | Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration | Change from Baseline at 6 months in 3 groups |
| Number of Teeth With Any Root Lesion From Radiography in 3 Groups | Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration | Change from Baseline at 12 months in 3 groups |
| Change from Baseline at 3 months |
| Restoration Stability | The survival rate of stainless steel crown and composite applied to each pulpotomized tooth | Change from Baseline at 6 months |
| Restoration Stability | The survival rate of stainless steel crown and composite applied to each pulpotomized tooth | Change from Baseline at 12 months |
| BG001 | Formocresol | 0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns (SSC) and composite filling material. |
| BG002 | Ferric Sulfate | 0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns (SSC) and composite filling material. |
| BG003 | Total | Total of all reporting groups |
| tooth |
|
| Participants |
| Participants |
|
|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
|
|
| Sex: Female, Male | Count of Units | tooth | tooth |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
|
| Dental Arch/Tooth Type | Count of Units | tooth | tooth |
|
|
| Dental Arch | Count of Units | tooth | tooth |
|
|
| Tooth Type | Count of Units | tooth | tooth |
|
|
| Final Restoration | Count of Units | tooth | tooth |
|
|
| OG002 | Ferric Sulfate | 0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material. |
|
|
|
| Primary | Number of Teeth Sensitive to Percussion in 3 Groups | Sensitivity to biting, chewing and clinically to the percussion by a probe | 1 tooth is extracted in HA group so 50 teeth are evaluated | Posted | Count of Units | teeth | Change from Baseline at 3 months in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth Sensitive to Percussion in 3 Groups | Sensitivity to biting, chewing and clinically to the percussion by a probe | 1 tooth exfoliated in FS group and 1 participant so no observation for 1 tooth and 1 participant in FS | Posted | Count of Units | teeth | Change from Baseline at 6 months in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth Sensitive to Percussion in 3 Groups | Sensitivity to biting, chewing and clinically to the percussion by a probe | 2 teeth exfoliated from HA group (not participants) so number of teeth reduced from 50 to 48 | Posted | Count of Units | teeth | Change from Baseline at 12 months in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Mobile Teeth in 3 Groups | Mobility of the treated tooth and/or the tooth is sensitive to the vibration | Posted | Count of Units | teeth | Change from Baseline at 1 month in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Mobile Teeth in 3 Groups | Mobility of the treated tooth and/or the tooth is sensitive to the vibration | 1 tooth extracted from HA group | Posted | Count of Units | teeth | Change from Baseline at 3 month in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Mobile Teeth in 3 Groups | Mobility of the treated tooth and/or the tooth is sensitive to the vibration | 1 tooth exfoliated from FS group (1 participant ) so 1 child and 1 tooth is reduced from FS group | Posted | Count of Units | teeth | Change from Baseline at 6 month in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Mobile Teeth in 3 Groups | Mobility of the treated tooth and/or the tooth is sensitive to the vibration | 2 teeth exfoliated from HA group (not participants) so 50 teeth reduced to 48 teeth but participants still exist | Posted | Count of Units | teeth | Change from Baseline at 12 months in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Patient Discomfort and/or Pain in 3 Groups | Any pain history at that time frame and/or complaint of discomfort and pain clinically | Posted | Count of Units | teeth | Change from Baseline at 1 month in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Patient Discomfort and/or Pain in 3 Groups | Any pain history at that time frame and/or complaint of discomfort and pain clinically | 1 tooth extracted from HA group | Posted | Count of Units | teeth | Change from Baseline at 3 months in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Patient Discomfort and/or Pain in 3 Groups | Any pain history at that time frame and/or complaint of discomfort and pain clinically | 1 tooth exfoliated (one participant) so 1 tooth and 1 participant are reduced from FS group | Posted | Count of Units | teeth | Change from Baseline at 6 months in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Patient Discomfort and/or Pain in 3 Groups | Any pain history at that time frame and/or complaint of discomfort and pain clinically | 2 teeth exfoliated in HA group so 50 teeth reduced to 48 but no participant is reduced | Posted | Count of Units | teeth | Change from Baseline at 12 months in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Dental Abscess in 3 Groups | Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically | Posted | Count of Units | teeth | Change from Baseline at 1 month in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Dental Abscess in 3 Groups | Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically | Posted | Count of Units | teeth | Change from Baseline at 3 months in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Dental Abscess in 3 Groups | Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically | 1 tooth exfoliated in FS group so 1 tooth and 1 participant are reduced in FS group | Posted | Count of Units | teeth | Change from Baseline at 6 months in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Dental Abscess in 3 Groups | Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically | 2 teeth exfoliated from HA group so number of teeth reduced from 50 to 48 but participants are same | Posted | Count of Units | teeth | Change from Baseline at 12 months | teeth | teeth |
|
|
|
|
| Primary | Number of the Pathological Exfoliation of Affected Teeth in 3 Groups | The tooth is missing or ready to exfoliate physiologically and no pathology is examined | Posted | Count of Units | teeth | Change from Baseline at 1 month in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of the Pathological Exfoliation of Affected Teeth in 3 Groups | The tooth is missing or ready to exfoliate physiologically and no pathology is examined | Posted | Count of Units | teeth | Change from Baseline at 3 months in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of the Pathological Exfoliation of Affected Teeth in 3 Groups | The tooth is missing or ready to exfoliate physiologically and no pathology is examined | Posted | Count of Units | teeth | Change from Baseline at 6 months in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of the Pathological Exfoliation of Affected Teeth in 3 Groups | The tooth is missing or ready to exfoliate physiologically and no pathology is examined | 2 exfoliations in HA group are shown here | Posted | Count of Units | teeth | Change from Baseline at 12 months in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Root Resorption in 3 Groups | Internal, external, early or physiological root resorption from periapical/panoramic radiographs | Posted | Count of Units | teeth | Change from Baseline at 1 month in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Root Resorption in 3 Groups | Internal, external, early or physiological root resorption from periapical/panoramic radiographs | 1 tooth extracted in HA group | Posted | Count of Units | teeth | Change from Baseline at 3 months in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Root Resorption in 3 Groups | Internal, external, early or physiological root resorption from periapical/panoramic radiographs | 1 tooth exfoliated from FS group so 1 tooth and 1 participant reduced in FS group | Posted | Count of Units | teeth | Change from Baseline at 6 months | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Root Resorption in 3 Groups | Internal, external, early or physiological root resorption from periapical/panoramic radiographs | 6 participants, 12 teeth missing for xrays, 2 exfoliations from HA group; 7 participants, 8 teeth missing for xrays from FC group; 7 participants, 7 teeth missing for xrays from FS group | Posted | Count of Units | teeth | Change from Baseline at 12 months | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Any Root Lesion From Radiography in 3 Groups | Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration | Posted | Count of Units | teeth | Change from Baseline at 1 month in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Any Root Lesion From Radiography in 3 Groups | Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration | 1 tooth is extracted in HA group so 1 tooth is reduced but not participant | Posted | Count of Units | teeth | Change from Baseline at 3 months in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Any Root Lesion From Radiography in 3 Groups | Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration | 1 tooth exfoliated in FS group so 1 tooth and 1 participant are not evaluated in FS group | Posted | Count of Units | teeth | Change from Baseline at 6 months in 3 groups | teeth | teeth |
|
|
|
|
| Primary | Number of Teeth With Any Root Lesion From Radiography in 3 Groups | Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration | 6 participants, 12 teeth missing for xrays, 2 exfoliations from HA group; 7 participants, 8 teeth missing for xrays from FC group; 7 participants, 7 teeth missing for xrays from FS group | Posted | Count of Units | teeth | Change from Baseline at 12 months in 3 groups | teeth | teeth |
|
|
|
|
| Secondary | Restoration Stability | The survival rate of stainless steel crown and composite applied to each pulpotomized tooth | Posted | Count of Units | teeth | Change from Baseline at 1 month | teeth | teeth |
|
|
|
|
| Secondary | Restoration Stability | The survival rate of stainless steel crown and composite applied to each pulpotomized tooth | 1 tooth extracted from HA group so reduced to 50 teeth but no participant reduction | Posted | Count of Units | teeth | Change from Baseline at 3 months | teeth | teeth |
|
|
|
|
| Secondary | Restoration Stability | The survival rate of stainless steel crown and composite applied to each pulpotomized tooth | 1 tooth exfoliated from FS group so 1 tooth and 1 participant reduced from FS group | Posted | Count of Units | teeth | Change from Baseline at 6 months | teeth | teeth |
|
|
|
|
| Secondary | Restoration Stability | The survival rate of stainless steel crown and composite applied to each pulpotomized tooth | 2 teeth exfoliated from HA group so 50 teeth reduced to 48 teeth in HA group | Posted | Count of Units | teeth | Change from Baseline at 12 months | teeth | teeth |
|
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Formocresol | 0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material. | 0 | 33 | 0 | 33 | 0 | 33 |
| EG002 | Ferric Sulfate | 0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material. | 0 | 34 | 0 | 34 | 0 | 34 |
|
Not provided
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| Male |
|
| Maxillary 2nd primary molars |
|
| Mandibular 1st primary molars |
|
| Mandibular 2nd primary molars |
|
| Upper Arch |
|
| 2nd primary molars |
|
| Composite |
|
| External resorption |
|
| No resorption |
|
| External resorption |
|
| No resorption |
|
| External resorption |
|
| No resorption |
|
| External resorption |
|
| No resorption |
|