Status:
ACTIVE_NOT_RECRUITING
Pulpotomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis
Lead Sponsor:
Qatar University
Collaborating Sponsors:
Primary Health Care Corporation, Qatar
Jordan University of Science and Technology
Conditions:
Irreversible Pulpitis
Eligibility:
All Genders
4-9 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Background: Pulpectomy continues to be the standard treatment recommendation for management of vital primary molars diagnosed with symptomatic irreversible pulpitis. The recent decade has seen a parad...
Eligibility Criteria
Inclusion
- Healthy (ASA I and II) co-operative children (Frankl Scale + and ++) between the ages of four and nine years.
- Participants have symptoms typical of irreversible pulpitis in one of the primary molars.
- The pulp of the affected primary molar is vital.
- Radicular pulp health is confirmed by attainment of radicular pulp haemostasis within 6 minutes of coronal pulp amputation.
- The affected primary molars can be restored with full coverage crowns.
- Any physiologic root resorption, if present, is less than ⅓ the root length
Exclusion
- Clinical examination of affected primary molar reveals signs of pulpal infection (e.g.
- pathologic tooth mobility, parulis/fistula, or soft tissue swelling)
- Pre-operative periapical radiograph suggests presence of periapical radiolucency.
- Pre-operative periapical radiograph suggests presence of furcal radiolucency more than ½ the furcation to periapical area.
- Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g.
- avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate).
- Signs of extensive radicular pulp inflammation.
- Parents not willing to place full coverage crowns post-pulpotomy.
- Clinical diagnosis of irreversible pulpitis between two teeth is not sharply defined.
Key Trial Info
Start Date :
March 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06149845
Start Date
March 21 2024
End Date
July 31 2027
Last Update
July 31 2025
Active Locations (2)
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1
Phcc - Airport Center
Doha, Qatar
2
PHCC- Leebaib Center
Doha, Qatar