Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The resident graduated.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months and 12 months.
Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months and 12 months. Regular recall and follow up will be performed for patients who has MTA or FS pulpotomies. Clinical and radiographic findings will be recorded.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mineral Trioxide Aggregate | Experimental | Subject with pulpotomy treated with MTA MTA paste (< 1gm) will be placed on pulp orifice once for the life of the primary teeth |
|
| Ferric Sulfate | Experimental | Subject with pulpotomy treated with FS FS paste (<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MTA | Device | Mineral Trioxide Aggregate grey paste |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars | At recall visits 6,9,12 months, blinded clinical examination will be completed by participating faculty members who are calibrated to clinical scaring criteria. Periapical radiographs will be taken and evaluated by 2 pediatric dentists and 1 endodontist, for presence of various pathologies. Scored based on the criteria established by Zurn and Seale 2008. Scores will be transferred to Microsoft Excel. The difference between the two materials will be analyzed using the Mann-Whiteney U test, chi-square test and Fisher's exact test. Intra- and inter-rater agreement will be measured for radiographic assessment using Cohen's kappa test | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jung-Wei Chen, DDS,MS,PhD | Loma Linda University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25631717 | Background | Asgary S, Shirvani A, Fazlyab M. MTA and ferric sulfate in pulpotomy outcomes of primary molars: a systematic review and meta-analysis. J Clin Pediatr Dent. 2014 Fall;39(1):1-8. doi: 10.17796/jcpd.39.1.b454r616m2582373. | |
| 26696101 | Result | Yildirim C, Basak F, Akgun OM, Polat GG, Altun C. Clinical and Radiographic Evaluation of the Effectiveness of Formocresol, Mineral Trioxide Aggregate, Portland Cement, and Enamel Matrix Derivative in Primary Teeth Pulpotomies: A Two Year Follow-Up. J Clin Pediatr Dent. 2016 Winter;40(1):14-20. doi: 10.17796/1053-4628-40.1.14. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
3-10 years old, deep caries, No radiographic signs of internal/external root resorption, No pathology change, no swelling or abscess.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mineral Trioxide Aggregate | Subject with pulpotomy treated with MTA MTA paste (< 1gm) will be placed on pulp orifice once for the life of the primary teeth MTA: Mineral Trioxide Aggregate grey paste |
| FG001 | Ferric Sulfate | Subject with pulpotomy treated with FS FS paste (<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth Ferric Sulfate: Ferric Sulfate paste |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
some participants has more than one tooth needs pulpotomy treatment
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mineral Trioxide Aggregate | Subject with pulpotomy treated with MTA MTA paste (< 1gm) will be placed on pulp orifice once for the life of the primary teeth MTA: Mineral Trioxide Aggregate grey paste |
| BG001 | Ferric Sulfate |
| 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 | Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars | At recall visits 6,9,12 months, blinded clinical examination will be completed by participating faculty members who are calibrated to clinical scaring criteria. Periapical radiographs will be taken and evaluated by 2 pediatric dentists and 1 endodontist, for presence of various pathologies. Scored based on the criteria established by Zurn and Seale 2008. Scores will be transferred to Microsoft Excel. The difference between the two materials will be analyzed using the Mann-Whiteney U test, chi-square test and Fisher's exact test. Intra- and inter-rater agreement will be measured for radiographic assessment using Cohen's kappa test | The patients who came back for follow up for long term clinical and radiographic success. | Posted | Count of Units | tooth | 1 year | tooth | tooth |
|
1 year
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mineral Trioxide Aggregate | Subject with pulpotomy treated with MTA MTA paste (< 1gm) will be placed on pulp orifice once for the life of the primary teeth MTA: Mineral Trioxide Aggregate grey paste |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jung-Wei Chen, Program director | LomaLindaU | 9095584690 | 85909 | jwchen@llu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 2, 2014 | Apr 22, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2014 | May 17, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 9, 2015 | May 17, 2021 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| C024823 | ferric sulfate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ferric Sulfate |
| Drug |
Ferric Sulfate paste |
|
|
| 25833280 | Result | Stringhini Junior E, Vitcel ME, Oliveira LB. Evidence of pulpotomy in primary teeth comparing MTA, calcium hydroxide, ferric sulphate, and electrosurgery with formocresol. Eur Arch Paediatr Dent. 2015 Aug;16(4):303-12. doi: 10.1007/s40368-015-0174-z. Epub 2015 Apr 2. |
| 23534318 | Result | Frenkel G, Kaufman A, Ashkenazi M. Clinical and radiographic outcomes of pulpotomized primary molars treated with white or gray mineral trioxide aggregate and ferric sulfate--long-term follow-up. J Clin Pediatr Dent. 2012 Winter;37(2):137-41. doi: 10.17796/jcpd.37.2.j3h27p624u163868. |
Subject with pulpotomy treated with FS FS paste (<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth
Ferric Sulfate: Ferric Sulfate paste
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| patient has deep caries | Count of Participants | Participants |
|
Subject with pulpotomy treated with MTA MTA paste (< 1gm) will be placed on pulp orifice once for the life of the primary teeth MTA: Mineral Trioxide Aggregate grey paste |
| OG001 | Ferric Sulfate | Subject with pulpotomy treated with FS FS paste (<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth Ferric Sulfate: Ferric Sulfate paste |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Ferric Sulfate | Subject with pulpotomy treated with FS FS paste (<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth Ferric Sulfate: Ferric Sulfate paste | 0 | 46 | 0 | 46 | 0 | 46 |
Not provided
Not provided