Irreversible Pulpitis Clinical Trial
Official title:
Treatment Outcomes of Pulpotomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis: An International Multi-centre Study
NCT number | NCT06149845 |
Other study ID # | QU2713 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 21, 2024 |
Est. completion date | September 2026 |
This is a clinical trial to assess the treatment outcomes of pulpotomy in vital primary molars diagnosed with symptomatic irreversible pulpitis. Pulpotomy is a more conservative treatment option over the conventional pulpectomy treatment. Compared to pulpectomy, pulpotomy is a technically simpler procedure, less time consuming, easier for young patients to tolerate, and retains the proprioceptive sensation of the tooth - all important advantages when treating young children.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | September 2026 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 9 Years |
Eligibility | Inclusion Criteria: 1. Healthy (ASA I and II) co-operative children (Frankl Scale + and ++) between the ages of four and nine years. 2. Participants have symptoms typical of irreversible pulpitis in one of the primary molars. 3. The pulp of the affected primary molar is vital. 4. Radicular pulp health is confirmed by attainment of radicular pulp haemostasis within 6 minutes of coronal pulp amputation. 5. The affected primary molars can be restored with full coverage crowns. 6. Any physiologic root resorption, if present, is less than ? the root length Exclusion Criteria: 1. Clinical examination of affected primary molar reveals signs of pulpal infection (e.g. pathologic tooth mobility, parulis/fistula, or soft tissue swelling) 2. Pre-operative periapical radiograph suggests presence of periapical radiolucency. 3. Pre-operative periapical radiograph suggests presence of furcal radiolucency more than ½ the furcation to periapical area. 4. Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate). 5. Signs of extensive radicular pulp inflammation. 6. Parents not willing to place full coverage crowns post-pulpotomy. 7. Clinical diagnosis of irreversible pulpitis between two teeth is not sharply defined. |
Country | Name | City | State |
---|---|---|---|
Qatar | Phcc - Airport Center | Doha | |
Qatar | PHCC- Leebaib Center | Doha |
Lead Sponsor | Collaborator |
---|---|
Qatar University | Cairo University, Dubai Dental Hospital, Hamdan Bin Mohammed College of Dental Medicine, Jordan University of Science and Technology, King Abdulaziz Hospital, Saudi Arabia, Mahidol University, Ministry of Health, Kuwait, NYU Langone Health, Primary Health Care Corporation, Qatar, Sun Life Health, Arizona |
Qatar,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-treatment clinical success | Clinical success will be determined at 6-, 12-, and 24-months based on the pulpotomy treated tooth meeting all the below criteria:
Treated tooth is not associated with any pain or discomfort Treated tooth is not associated with tenderness on percussion or palpation Treated tooth is not associated with any swelling, parulis, or fistula Treated tooth is not associated with any pathological mobility |
6 months, 12 months, 24 months | |
Secondary | Immediate post-treatment pain relief | Pain scores that will be recorded at 24-hours and 7-days post-treatment using a child friendly Visual Analogue Scale (VAS). This pain score will be used to evaluate pain reduction afforded by the pulpotomy treatment intervention. | 24 hours; 7 days | |
Secondary | Post-treatment radiographic success | Radiographic success will be determined at 6-, 12-, and 24-months based on the pulpotomy treated tooth meeting all the below criteria:
No signs of pathological internal/external root resorption or new furcal/periapical lesions on recall periapical radiographs Complete radiographic healing or reduction/no change in size of any pre-treatment furcal rarefaction on recall periapical radiographs |
6 months, 12 months, 24 months |
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