Clinical trial NCT06504108: Full Pulpotomy Procedure of Permanent Molar Teeth of Adults Using Calcium Silicate-based Sealer Material
Official title: Evaluation Of The Efficacy Of Using Calcium-Silicate Based Sealers As A Pulp Capping Material After Adult Pulpotomy: An In-vivo Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Irreversible Pulpitis
Keywords: pulpotomy
calcium silicate-based sealer
irreversible pulpitis
MTA
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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\&#39; 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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.
* 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.

Primary outcomes:
measure: Clinical success after full pulpotomy procedure
timeFrame: immediate postoperative
measure: Radiographic success after full pulpotomy procedure
timeFrame: immediate postoperative
measure: Clinical success after full pulpotomy procedure
timeFrame: At 1 month
measure: Cinical success after full pulpotomy procedure
timeFrame: At 3 months
measure: Clinical success after full pulpotomy procedure
timeFrame: At 6 months
measure: Radiographic success after full pulpotomy procedure
timeFrame: At 6 months
measure: Clinical success after full pulpotomy procedure
timeFrame: At 9 months
measure: Clinical success after full pulpotomy procedure
timeFrame: At 12 months
measure: Radiographic success after full pulpotomy procedure
timeFrame: At 12 months
Secondary outcomes:
measure: Assessment of Post-operative pain after full pulpotomy procedure
timeFrame: 6 hours, 24 hours, 48 hours, 72 hours and 7 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine, Al-Azhar University
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine, Al-Azhar University
Study officials:
affiliation: Faculty of Dental Medicine, Al-Azhar University, Cairo
name: Moataz A Elkhawas, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.