Full Pulpotomy Procedure of Permanent Molar Teeth of Adults Using Calcium Silicate-based Sealer Material

NCT06504108 | Not Yet Recruiting DMC

• 1 other identifier: 959/1498
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Irreversible Pulpitis

Keywords

pulpotomy; calcium silicate-based sealer; irreversible pulpitis; MTA

Outcome Measures

Primary Outcomes (9)

• 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.

  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

Secondary Outcomes (1)

• Assessment of Post-operative pain after full pulpotomy procedure

  6 hours, 24 hours, 48 hours, 72 hours and 7 days

Study Arms (3)

calcium silicate-based sealer

EXPERIMENTAL

Performing full pulpotomy of permanent mandibular and maxillary molar teeth using calcium silicate-based sealer as a capping agent.

Procedure: Calcium silicate-based sealer full Pulpotomy

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.

Procedure: Calcium silicate-based premixed putty full Pulpotomy

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.

Procedure: Full Pulpotomy

Interventions

Calcium silicate-based sealer full Pulpotomy PROCEDURE

Using calcium silicate-based sealer as a capping agent after full pulpotomy

calcium silicate-based sealer

Calcium silicate-based premixed putty full Pulpotomy PROCEDURE

Using calcium silicate-based premixed putty as a capping agent after full pulpotomy

Premixed calcium silicate-based putty

Full Pulpotomy PROCEDURE

Using combination between calcium silicate-based sealer and calcium silicate-based premixed putty as a capping agent after full pulpotomy

combination between calcium silicate-based sealer and premixed calcium silicate-based putty

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Vital mandibular molar teeth with mature apices.
• 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.

You may not qualify if:

• Pre-operative 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (2)

Faculty of Dental Medicine, Al-Azhar University

Cairo, 11651, Egypt

Location

Faculty of Dental Medicine, Al-Azhar University

Cairo, 11651, Egypt

Location

Related Publications (7)

• 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.

  PMID: 34563506 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.

  PMID: 34854987 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.

  PMID: 24771228 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.

  PMID: 19335509 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.

  PMID: 31865629 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.

  PMID: 37452640 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.

  PMID: 37080387 BACKGROUND

Study Officials

• Moataz A Elkhawas, PhD

  Faculty of Dental Medicine, Al-Azhar University, Cairo

  STUDY CHAIR

Central Study Contacts

Mahmoud Y Abdelsalam, Master Degree

CONTACT

8001111111; mahmoudyahia96@gmail.com

Motaz M Elsadat, PhD

CONTACT

8002222222; motazelsadat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree in Endodontics

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 16, 2024
• Study Start: July 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: May 1, 2026
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Once I get the Results
• Access Criteria: Full access to the selected data

Locations

EG (2)