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This clinical study aims to assess the efficacy of using calcium silicate based sealer as a capping material after complete removal of coronal pulp tissue. The study will evaluate both the clinical and radiographic changes.
Root canal treatment has always been considered the first line of treatment for carious teeth with symptomatic irreversible pulpitis for a long time. However, after the evolution of calcium silicate based materials a more conservative option, which is pulpotomy began to gain reliability, especially that it preserves the vitality of the radicular pulp, clinically simpler, less time-consuming, and more cost-effective compared to conventional root canal treatment.
In this study the investigators assess the clinical and radiographic success rate of using calcium silicate based sealer as a pulp capping material in permanent molars after pulpotomy.
For the best of the investigators' knowledge, there is no available clinical data on the use of calcium-silicate based sealers as a pulp capping material in pulpotomy of permanent molars with symptoms of irreversible pulpitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| calcium silicate-based sealer | Experimental | Performing full pulpotomy of permanent mandibular and maxillary molar teeth using calcium silicate-based sealer as a capping agent. |
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| Premixed calcium silicate-based putty | Active Comparator | Performing full pulpotomy of permanent mandibular and maxillary molar teeth using premixed calcium silicate-based putty as a capping agent. |
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| combination between calcium silicate-based sealer and premixed calcium silicate-based putty | Experimental | Performing full pulpotomy of permanent mandibular and maxillary molar teeth using a combination of calcium silicate-based sealer and premixed calcium silicate-based putty as a capping agent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium silicate-based sealer full Pulpotomy | Procedure | Using calcium silicate-based sealer as a capping agent after full pulpotomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success after full pulpotomy procedure | Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility. | immediate postoperative |
| Radiographic success after full pulpotomy procedure | Radiographic evaluation of the targeted tooth is performed and the treatment is considered successful in case of presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of peri-radicular radiolucency and no loss or break of lamina dura. | immediate postoperative |
| Clinical success after full pulpotomy procedure | Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling, absence of sinus tract or fistula and absence of tooth mobility. | At 1 month |
| Cinical success after full pulpotomy procedure | Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility. | At 3 months |
| Clinical success after full pulpotomy procedure | Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Post-operative pain after full pulpotomy procedure | The postoperative pain was assessed by using the modified verbal descriptor Scale (mVDS). Patients were instructed to place a mark on the horizontal scale to represent the intensity of pain experienced, furthermore, they were asked to use the verbal descriptors as a guide. The level of pain was documented at the range of 0-10 numerically and verbally as no pain (0), slight pain (1, 2), moderate pain (3-5), strong pain (6, 7), severe pain (8), and maximum pain (9, 10). |
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Inclusion Criteria:
Exclusion Criteria:
Pre-operative criteria:
Intra-operative criteria:
Post-operative criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud Y Abdelsalam, Master Degree | Contact | 8001111111 | mahmoudyahia96@gmail.com | |
| Motaz M Elsadat, PhD | Contact | 8002222222 | motazelsadat@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Moataz A Elkhawas, PhD | Faculty of Dental Medicine, Al-Azhar University, Cairo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dental Medicine, Al-Azhar University | Cairo | 11651 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34563506 | Background | Taha NA, Al-Khatib H. 4-Year Follow-up of Full Pulpotomy in Symptomatic Mature Permanent Teeth with Carious Pulp Exposure Using a Stainproof Calcium Silicate-based Material. J Endod. 2022 Jan;48(1):87-95. doi: 10.1016/j.joen.2021.09.008. Epub 2021 Sep 24. | |
| 34854987 | Background | Asgary S, Eghbal MJ, Shahravan A, Saberi E, Baghban AA, Parhizkar A. Outcomes of root canal therapy or full pulpotomy using two endodontic biomaterials in mature permanent teeth: a randomized controlled trial. Clin Oral Investig. 2022 Mar;26(3):3287-3297. doi: 10.1007/s00784-021-04310-y. Epub 2021 Dec 2. |
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I am planning to share the study protocol and clinical study report
Once I get the Results
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| Calcium silicate-based premixed putty full Pulpotomy | Procedure | Using calcium silicate-based premixed putty as a capping agent after full pulpotomy |
|
| Full Pulpotomy | Procedure | Using combination between calcium silicate-based sealer and calcium silicate-based premixed putty as a capping agent after full pulpotomy |
|
| At 6 months |
| Radiographic success after full pulpotomy procedure | Radiographic evaluation of the targeted tooth is performed and the treatment is considered successful in case of presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of peri-radicular radiolucency and no loss or break of lamina dura. | At 6 months |
| Clinical success after full pulpotomy procedure | Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility. | At 9 months |
| Clinical success after full pulpotomy procedure | Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility. | At 12 months |
| Radiographic success after full pulpotomy procedure | Radiographic evaluation of the targeted tooth is performed and the treatment is considered successful in case of presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of peri-radicular radiolucency and no loss or break of lamina dura. | At 12 months |
| 6 hours, 24 hours, 48 hours, 72 hours and 7 days |
| Faculty of Dental Medicine, Al-Azhar University | Cairo | 11651 | Egypt |
|
| 24771228 | Background | Asgary S, Eghbal MJ, Fazlyab M, Baghban AA, Ghoddusi J. Five-year results of vital pulp therapy in permanent molars with irreversible pulpitis: a non-inferiority multicenter randomized clinical trial. Clin Oral Investig. 2015 Mar;19(2):335-41. doi: 10.1007/s00784-014-1244-z. Epub 2014 Apr 27. |
| 19335509 | Background | Eghbal MJ, Asgary S, Baglue RA, Parirokh M, Ghoddusi J. MTA pulpotomy of human permanent molars with irreversible pulpitis. Aust Endod J. 2009 Apr;35(1):4-8. doi: 10.1111/j.1747-4477.2009.00166.x. |
| 31865629 | Background | Lin LM, Ricucci D, Saoud TM, Sigurdsson A, Kahler B. Vital pulp therapy of mature permanent teeth with irreversible pulpitis from the perspective of pulp biology. Aust Endod J. 2020 Apr;46(1):154-166. doi: 10.1111/aej.12392. Epub 2019 Dec 21. |
| 37452640 | Background | Tzanetakis GN, Koletsi D, Georgopoulou M. Treatment outcome of partial pulpotomy using two different calcium silicate materials in mature permanent teeth with symptoms of irreversible pulpitis: A randomized clinical trial. Int Endod J. 2023 Oct;56(10):1178-1196. doi: 10.1111/iej.13955. Epub 2023 Jul 26. |
| 37080387 | Background | Taha NA, Abuzaid AM, Khader YS. A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction. J Endod. 2023 Jun;49(6):624-631.e2. doi: 10.1016/j.joen.2023.04.001. Epub 2023 Apr 19. |