Full Pulpotomy Procedure of Permanent Molar Teeth of Adults Using Calcium Silicate-based Sealer Material
NCT ID: NCT06504108
Last Updated: 2024-07-16
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
78 participants
INTERVENTIONAL
2024-07-31
2026-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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calcium silicate-based sealer
Performing full pulpotomy of permanent mandibular and maxillary molar teeth using calcium silicate-based sealer as a capping agent.
Calcium silicate-based sealer full Pulpotomy
Using calcium silicate-based sealer as a capping agent after full pulpotomy
Premixed calcium silicate-based putty
Performing full pulpotomy of permanent mandibular and maxillary molar teeth using premixed calcium silicate-based putty as a capping agent.
Calcium silicate-based premixed putty full Pulpotomy
Using calcium silicate-based premixed putty as a capping agent after full pulpotomy
combination between calcium silicate-based sealer and premixed calcium silicate-based putty
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.
Full Pulpotomy
Using combination between calcium silicate-based sealer and calcium silicate-based premixed putty as a capping agent after full pulpotomy
Interventions
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Calcium silicate-based sealer full Pulpotomy
Using calcium silicate-based sealer as a capping agent after full pulpotomy
Calcium silicate-based premixed putty full Pulpotomy
Using calcium silicate-based premixed putty as a capping agent after full pulpotomy
Full Pulpotomy
Using combination between calcium silicate-based sealer and calcium silicate-based premixed putty as a capping agent after full pulpotomy
Eligibility Criteria
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Inclusion Criteria
* Teeth that respond positively to cold testing.
* Teeth without any signs of necrosis including sinus tract or swelling.
* Teeth with caries extending ≥ 2/3 of dentine or exposing the pulp.
* Teeth with symptomatic irreversible pulpitis with/without apical periodontitis.
* Teeth without periodontal diseases or mobility.
* Teeth without root resorption, detectable pulp chamber and root canal calcification or history of trauma.
* Patients from both genders with age range from 20 to 45 years old.
* Patients with good or moderate oral hygiene and without any systemic diseases.
Exclusion Criteria
* Non-vital teeth.
* Teeth with irreversible pulpitis with apical periodontitis.
* Teeth with immature apices.
* Teeth with Periodontal disease or mobility grade II or III.
* Teeth that are badly decayed and need post and core placement.
* Patients refused to continue treatment procedures or refuse to commit to periodic follow-up sessions.
* Non-restorable teeth.
Intra-operative criteria:
* If hemostasis could not be achieved within 6 minutes after full pulpotomy.
* Teeth with partial necrosis.
* No bleeding after access cavity preparation.
Post-operative criteria:
* presence of Swelling.
* presence of Sinus tract.
* Pain on percussion after the end of the first week.
* Pain with palpation.
* Pain on biting after the end of first week.
* Mobility of the tooth.
* Fracture of tooth structure that renders the tooth non-restorable.
* Fracture of the restoration during the evaluation.
* Probing depth more than 3 mm.
20 Years
45 Years
ALL
No
Sponsors
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Al-Azhar University
OTHER
Responsible Party
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Mahmoud Yahia Ramadan Abdelsalam
Master Degree in Endodontics
Principal Investigators
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Moataz A Elkhawas, PhD
Role: STUDY_CHAIR
Faculty of Dental Medicine, Al-Azhar University, Cairo
Locations
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Faculty of Dental Medicine, Al-Azhar University
Cairo, , Egypt
Faculty of Dental Medicine, Al-Azhar University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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959/1498
Identifier Type: -
Identifier Source: org_study_id
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