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NCT06183203
Treatment Outcomes of Pulpotomy vs. Pulpectomy in Vital Primary Molars With Symptomatic Irreversible Pulpitis
Conditions: Irreversible Pulpitis
Sex: All
Ages: 4 Years – 9 Years
Healthy volunteers: Yes
Phase: NA
Sponsor: Nebu Philip
Location: Christian Dental College Ludhiana Punjab
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 to the standard pulpectomy treatment, pulpotomy is a technically simpler procedure, less time consuming, easier for young patients to tolerate, while retaining the proprioceptive sensation of the tooth - all important advantages when treating young children.
Eligibility Criteria
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 8 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 ⅓ 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-treatment.
7. Clinical diagnosis of irreversible pulpitis between two primary molars is not sharply defined
Source: ClinicalTrials.gov (NCT06183203). StuddyBuddy aggregates publicly available trial information.