Actively Recruiting
Comparative Evaluation of Indirect and Direct Pulp Capping After Partial or Complete Caries Removal in Deeply Carious Mature Permanent Mandibular Molars With Moderate Pulpitis: A Randomized Clinical Trial
Led by Postgraduate Institute of Dental Sciences Rohtak · Updated on 2026-02-12
106
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are comparing two dental treatments—indirect and direct pulp capping—in adult patients with deeply decayed mature mandibular molars showing signs of moderate pulp inflammation called moderate pulpitis. This trial aims to evaluate which method better preserves tooth vitality and reduces pain. The study focuses on teeth with clinical and radiographic signs that suggest moderate pulpitis, a condition where the pulp shows prolonged sensitivity and dull pain but may still recover if treated properly. The trial involves two treatment approaches. One group will receive partial removal of the decayed tissue followed by indirect pulp capping, where a protective material called MTA is applied over the remaining dentin, then sealed with a resin and composite restoration. The other group will undergo complete caries removal, which may expose the pulp, followed by direct pulp capping where the exposed pulp is treated with MTA, sealed with resin, and restored with composite. Both treatments are performed under sterile conditions to promote healing. Participants will be monitored over 12 months to assess clinical and X-ray success of the treatments. Pain levels will be recorded daily for one week after treatment to evaluate reduction in discomfort. Follow-up visits will include pulp sensibility tests and radiographs to check tooth health and healing. This trial lasts for one year, with regular check-ups to track outcomes and treatment success in these dental procedures.
CONDITIONS
Brief Title
Comparative Evaluation of Indirect vs. Direct Pulp Capping in Deep Carious Mandibular Molars
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older
- Restorable mature permanent first or second mandibular molars with deep caries reaching the inner quarter of dentin
- Tooth shows positive response to pulp sensibility testing
- Clinical diagnosis of moderate pulpitis
- Radiographic periapical index (PAI) score of 2 or less
- Healthy periodontal status with probing pocket depth of 3 mm or less and normal tooth mobility
- Pulp exposure after complete caries removal
- No pulp exposure after incomplete caries removal
You will not qualify if you...
- Teeth with immature roots
- Pulp exposure after incomplete caries removal
- No pulp exposure after complete caries removal
- Bleeding that cannot be controlled within 5 minutes
- Signs of pulp death, sinus tract, swelling, or insufficient bleeding after pulp exposure
- Recent analgesic use in past week or antibiotic use in past month
- Presence of internal or external root resorption
- Medical history including alcoholism, smoking, diabetes, hypertension, drug dependency, heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver disease, or migraine
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment visit
Participants receive either partial caries removal followed by Indirect pulp capping or complete caries removal followed by Direct pulp capping with a medicament and composite restoration.
1 treatment visit (in-person)
Duration - 12 months
Participants are assessed for pain reduction daily for 7 days and clinical and radiographic success at 12 months after treatment.
Daily pain assessments for 7 days and follow-up visits at 12 months
Trial Site Locations
Total: 1 location
1
PGIDS, Rohtak
Rohtak, Haryana, India
Actively Recruiting
Research Team
D
Dr. Vinay Kumar, MDS
D
Dr. Soma Chanakya, MDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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