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Clinical Trials/NCT06504108
NCT06504108
Not yet recruiting
Not Applicable

Evaluation Of The Efficacy Of Using Calcium-Silicate Based Sealers As A Pulp Capping Material After Adult Pulpotomy: An In-vivo Study

Al-Azhar University1 site in 1 country78 target enrollmentJuly 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Irreversible Pulpitis
Sponsor
Al-Azhar University
Enrollment
78
Locations
1
Primary Endpoint
Cinical success after full pulpotomy procedure
Status
Not yet recruiting
Last Updated
last year

Overview

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\' 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.

Registry
clinicaltrials.gov
Start Date
July 2024
End Date
May 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Yahia Ramadan Abdelsalam

Master Degree in Endodontics

Al-Azhar University

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.

Outcomes

Primary Outcomes

Cinical success after full pulpotomy procedure

Time Frame: At 3 months

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.

Clinical success after full pulpotomy procedure

Time Frame: At 12 months

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.

Radiographic success after full pulpotomy procedure

Time Frame: At 12 months

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.

Secondary Outcomes

  • Assessment of Post-operative pain after full pulpotomy procedure(6 hours, 24 hours, 48 hours, 72 hours and 7 days)

Study Sites (1)

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