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The aim of this prospective, randomized, controlled double-blind study is to evaluate the effectiveness of biodentine compared with MTA used as pulp space barrier on discoloration of teeth after regenerative based non-obturation root canal treatment in mature single canal with pulp necrosis and apical periodontitis.
• Regenerative endodontic treatment will be performed through two visits: First visit aims to clean and disinfect the tooth canal by copious irrigation with NaOCL and EDTA solution . At the end of first visit, canal will be dressed by CaOH as intracanal medicaments.
Second visit will be after two weeks. After removal of CaOH dressing by copius irrigation, evoking bleeding inside canal by over instrumentation. When blood become semi-coagulated, according to the random sequence number of the participants, either biodentine or white MTA will be placed as pulp space barrier.
At the end of treatment, the access cavity will be sealed with composite restoration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biodentine | Experimental | Intervention group: application of biodentine as pulp space barrier during regenerative endodontic treatment. |
|
| White MTA | Active Comparator | Control group: application of White MTA as pulp space barrier during regenerative endodontic treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodentine | Other | Biodentine is calcium silicate based cement which is bioactive and inductive material. Biodentine will be applied as coronal plug material. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Discoloration of teeth | Discoloration of teeth that will be assessed clinically through follow up period 3, 6, 9, 12 months by visual examination and by using color shade guide (Tetric N shade guide, Ivoclar Vivadent) whether tooth discolored or not in comparison with the original preoperative color shade. | Up to one Year after completion of regenerative endodontic treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Healing of Periapical Tissue | Healing of periapical tissue will be assessed clinically and radiographically through follow up period: 3, 6, 9, 12 months. When the case is clinically asymptomatic: (without sinus tract, swelling, with no palpation, or percussions pain) and radiographically showed absence or reduction of the radiolucency are together will considered successful of regenerative treatment. |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients having significant systemic disorder or immunocompromised patients. 2. Teeth with generalized chronic periodontitis or have periodontal pocket larger than 3 mm.
3. Teeth with developmental anomalies (i.e, dens invaginatusor a palatogingival groove).
4. Teeth with previous root canal. 5. Teeth need to post and core as final restoration
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| Name | Affiliation | Role |
|---|---|---|
| Amatallah HN Al-Rawhani, Master | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dentistry Faculty | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31155298 | Result | Arslan H, Ahmed HMA, Sahin Y, Doganay Yildiz E, Gundogdu EC, Guven Y, Khalilov R. Regenerative Endodontic Procedures in Necrotic Mature Teeth with Periapical Radiolucencies: A Preliminary Randomized Clinical Study. J Endod. 2019 Jul;45(7):863-872. doi: 10.1016/j.joen.2019.04.005. Epub 2019 May 31. |
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| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| C506393 | tricalcium silicate |
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Participants/ outcome assessor will be blinded
| White MTA | Other | MTA is calcium silicate based cement which is bioactive and inductive material. MTA is used in most cases of regenerative endodontics and it will be applied as coronal plug material. |
|
|
| after 3, 6,9 and Up to 12 months after completion of regenerative endodontic treatment |
| Restoring the sensibility of tooth | Electric pulp tester (EPT) | after 6,9 and Up to 12 months after completion of regenerative endodontic treatment |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |