A study to compare two treatment procedures for painful primary molars with inflammed dental pulp
- Conditions
- Health Condition 1: K040- Pulpitis
- Registration Number
- CTRI/2024/02/062274
- Lead Sponsor
- Joe Cherian
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 ? the root length
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 or minimally bleeding pulp tissue, yellowish necrotic areas, or 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Post-treatment clinical success: <br/ ><br>Determined based on treated tooth meeting all clinical success criteria (Absence of pain or discomfort; Absence of tenderness on percussion or palpation; Absence of parulis or fistula; Absence of soft tissue swelling; and Absence of any pathological mobility). <br/ ><br> <br/ ><br>2. Post-treatment radiographic success: <br/ ><br>Determined based on treated tooth meeting radiographic success criteria (No signs of pathological internal or external root resorption; No new furcal or periapical lesions; Complete radiographic healing or reduction or no change in the size of any pre-treatment furcal lesions).Timepoint: 6, 12 and 24 months
- Secondary Outcome Measures
Name Time Method Immediate post-treatment pain reliefTimepoint: 24 hours and 7-days