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

February 9, 2026 updated by: Postgraduate Institute of Dental Sciences Rohtak

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Vital pulp therapy has been traditionally recommended only in teeth with reversible pulpitis with no periapical pathologies or in teeth with either mechanical pulp exposure or recent traumatic exposure. Clinical symptoms such as characteristics, severity and intensity of pre-operative pain do not accurately talk about the status of the pulp inflammation and the depth of involvement. It has been demonstrated that there is no precise correlation between clinical symptoms and the histopathological status of the pulp, mainly in case of irreversible pulpitis, that might lead to a wrong diagnosis. Vitality tests such as cold test or electric pulp tests reveal only whether the pulp is responsive to respective stimuli or not. According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which corresponds to irreversible pulpitis. Vital pulp therapy is suggested to be the choice of treatment for such cases. It has been suggested that infection is often a cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Partial caries removal, which involves complete removal of carious dentine from the surrounding cavity walls, followed by the partial removal of infected dentin at the pulpal wall which reduce chances of pulp exposure followed by placement of medicament for Indirect pulp capping. Whereas during Complete caries removal, caries is completely removed from surrounding walls as well as on pulpal wall which increase the chances of pulp exposure followed by placement of medicament for Direct pulp capping procedure. Based on this premise, IPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of direct pulp capping, partial pulpotomy or full pulpotomy in adults.

Research Question Does Indirect Pulp Capping have comparable outcome with Direct pulp capping after partial caries removal in deeply carious mature permanent molars with clinical signs indicative of moderate pulpitis? P (Population) - Deeply carious mature Permanent Mandibular molars with clinical signs indicative of moderate pulpitis I (Intervention) - Partial caries removal followed by Indirect pulp capping C (Comparison) - Complete caries removal followed by Direct pulp capping O (Outcome) - Assessment of clinical and radiographic success at 12 months follow up.

  • To assess incidence and reduction in pain post operatively at every 24 hours till 1 week.

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Haryana
      • Rohtak, Haryana, India
        • Recruiting
        • PGIDS, Rohtak
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Partial caries removal followed by Indirect pulp capping.
Procedure: 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.
Active Comparator: Complete caries removal followed by Direct Pulp Capping
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Success Rate
Time Frame: 12 months
No pain or discomfort. No tenderness to palpation or percussion. Normal mobility and probing pocket depth.
12 months
Radiographic success
Time Frame: 12 months
No pathology on the radiograph.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reduction
Time Frame: Seven days
Post operative pain To assess pain postoperatively at every 24 hours till 7 days using Visual analogue Scale.
Seven days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Investigators

  • Study Director: Dr, Sanjay Tewari, MDS, PGIDS, Rohtak, Haryana, 124001

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2024

Primary Completion (Estimated)

March 23, 2026

Study Completion (Estimated)

March 23, 2026

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soma Chanakya

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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