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Recruiting Not applicable

Comparative Evaluation of Indirect vs. Direct Pulp Capping in Deep Carious Mandibular Molars

NCT06433297 · tracked via the Priya Life Science India tracker
Phase
Not applicable
Started
2024-05-23
Last updated
2026-02-12

Condition(s) studied

Indirect Pulp CappingReversible Pulpitis

Investigational drug(s) / intervention(s)

INDIRECT AND DIRECT PULP CAPPING AFTER PARTIAL OR COMPLETE CARIES REMOVAL IN DEEPLY CARIOUS MATURE PERMANENT MANDIBULAR MOLARS WITH MODERATE PULPITIS

INDIRECT AND DIRECT PULP CAPPING AFTER PARTIAL OR COMPLETE CARIES REMOVAL IN DEEPLY CARIOUS MATURE PERMANENT MANDIBULAR MOLARS WITH MODERATE PULPITIS: After partial caries removal the cavity is disinfected, dried, and capped with a 2-3mm layer of MTA followed by a light-cured resin layer. The tooth is then definitively restored with composite. Following complete caries removal, any bleeding pulp will be controlled with sodium hypochlorite for up to 5 minutes. Exposed pulp will then be directly capped with a 2-3mm layer of MTA, followed by a light-cured resin layer and definitive composite restoration using an etch-and-rinse technique.

Study summary

Aim: To compare the outcome of indirect and direct pulp capping after partial or complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.

Objectives:

1. To evaluate the clinical and radiographic success of indirect pulp capping after partial caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
2. To evaluate the clinical and radiographic success of direct pulp capping after complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
3. To evaluate pain incidence and severity after indirect and direct pulp capping after partial and complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. The patient should be ≥18 years of age. 2. Restorable mature permanent 1st and 2nd Mandibular molars with deep caries (reaching inner quarter of dentine) 3. Tooth should give positive response to pulp sensibility testing. 4. Clinical diagnosis of moderate pulpitis. 5. Radiographic finding of periapical index (PAI) score ≤2. 6. Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit). 7. Pulp exposure after complete caries excavation. 8. No pulp exposure after incomplete caries excavation Exclusion Criteria: 1. Teeth with immature roots. 2. Pulp exposure after incomplete caries excavation. 3. No pulp exposure after complete caries excavation. 4. Bleeding could not be controlled in 5 minutes. 5. Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure. 6. History of analgesic intake in previous 1 week, or antibiotic intake in 1 month. 7. Internal/external resorption. 8. Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine)

Primary outcome measure(s)

  • Clinical Success Rate — 12 months
    No pain or discomfort. No tenderness to palpation or percussion. Normal mobility and probing pocket depth.
  • Radiographic success — 12 months
    No pathology on the radiograph.

Trial sites (1)

FacilityCityRegionStatus
PGIDS, Rohtak Rohtak Haryana Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06433297 on ClinicalTrials.gov ↗ ← All trials in India