Status:
NOT_YET_RECRUITING
Treatment Outcomes of Pulpotomy vs. Pulpectomy in Vital Primary Molars With Symptomatic Irreversible Pulpitis
Lead Sponsor:
Nebu Philip
Collaborating Sponsors:
Christian Dental College
Conditions:
Irreversible Pulpitis
Eligibility:
All Genders
4-9 years
Phase:
NA
Brief Summary
This randomised controlled trial aims to compare treatment outcomes between pulpotomy and pulpectomy when used to treat vital primary molars diagnosed with symptomatic irreversible pulpitis. Compared ...
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 8 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-treatment.
- Clinical diagnosis of irreversible pulpitis between two primary molars is not sharply defined
Key Trial Info
Start Date :
February 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06183203
Start Date
February 15 2024
End Date
June 30 2027
Last Update
February 6 2024
Active Locations (1)
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1
Christian Dental College
Ludhiana, Punjab, India, 141008