Status:
NOT_YET_RECRUITING
Full Pulpotomy Procedure of Permanent Molar Teeth of Adults Using Calcium Silicate-based Sealer Material
Lead Sponsor:
Al-Azhar University
Conditions:
Irreversible Pulpitis
Eligibility:
All Genders
20-45 years
Phase:
NA
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 an...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06504108
Start Date
July 1 2024
End Date
May 1 2026
Last Update
July 16 2024
Active Locations (2)
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1
Faculty of Dental Medicine, Al-Azhar University
Cairo, Egypt, 11651
2
Faculty of Dental Medicine, Al-Azhar University
Cairo, Egypt, 11651