Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06433297

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

On this page

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

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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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