Full Pulpotomy Procedure of Permanent Molar Teeth of Adults Using Calcium Silicate-based Sealer Material
Launched by AL-AZHAR UNIVERSITY · Jul 14, 2024
Trial Information
Current as of May 04, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a dental procedure called full pulpotomy, which involves removing the damaged part of the tooth's pulp (the soft tissue inside) from adult molars that have irreversible pulpitis, a painful condition caused by inflammation. The goal is to see how effective a special material made from calcium silicate works as a protective covering (or "capping material") after the pulp is removed. Researchers will look at both how the tooth heals over time and images (like X-rays) to assess changes in the tooth's condition.
To be eligible for this study, participants should be adults aged 20 to 45 with healthy molar teeth that show signs of pain but are still responsive to cold tests. They should not have signs of infection, severe decay, or other dental issues. If you choose to participate, you can expect to undergo the pulpotomy procedure and receive follow-up care to monitor your recovery. Importantly, this trial is still in the early stages and has not started recruiting participants yet.
Gender
ALL
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.
About Al Azhar University
Al-Azhar University, a prestigious institution in Egypt, is dedicated to advancing medical research and education through rigorous clinical trials. With a strong emphasis on ethical standards and scientific integrity, the university aims to contribute to the development of innovative therapies and healthcare solutions. By fostering collaboration among researchers, healthcare professionals, and academic experts, Al-Azhar University positions itself as a leading sponsor in clinical research, committed to improving patient outcomes and enhancing the understanding of various medical conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cairo, , Egypt
Patients applied
Trial Officials
Moataz A Elkhawas, PhD
Study Chair
Faculty of Dental Medicine, Al-Azhar University, Cairo
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported