Full Pulpotomy Procedure of Permanent Molar Teeth of Adults Using Calcium Silicate-based Sealer Material
NCT Number: NCT06504108
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Irreversible Pulpitis
Interventions: PROCEDURE: Calcium silicate-based sealer full Pulpotomy|PROCEDURE: Calcium silicate-based premixed putty full Pulpotomy|PROCEDURE: Full Pulpotomy
Sponsor: Al-Azhar University
Sex: ALL
Age: ADULT
Enrollment: 78
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-05
Locations: Faculty of Dental Medicine, Al-Azhar University, Cairo, 11651, Egypt|Faculty of Dental Medicine, Al-Azhar University, Cairo, 11651, Egypt

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.

Primary Outcome Measures: 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 Outcome Measures: 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)., 6 hours, 24 hours, 48 hours, 72 hours and 7 days