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

NCT06433297 | Recruiting

• 1 other identifier: Soma Chanakya
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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.

Conditions

Indirect Pulp Capping; Reversible Pulpitis

Keywords

indirect pulp capping; selective caries removal; moderate pulpitis; direct pulp capping; deep caries; complete caries removal; mature permanent mandibular molars

Outcome Measures

Primary Outcomes (2)

• Clinical Success Rate

  No pain or discomfort. No tenderness to palpation or percussion. Normal mobility and probing pocket depth.

  12 months

• Radiographic success

  No pathology on the radiograph.

  12 months

Secondary Outcomes (1)

• Pain reduction

  Seven days

Study Arms (2)

Partial caries removal followed by Indirect pulp capping.

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

Complete caries removal followed by Direct Pulp Capping

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

Interventions

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

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.

Complete caries removal followed by Direct Pulp Capping; Partial caries removal followed by Indirect pulp capping.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient should be ≥18 years of age.
• Restorable mature permanent 1st and 2nd Mandibular molars with deep caries (reaching inner quarter of dentine)
• Tooth should give positive response to pulp sensibility testing.
• Clinical diagnosis of moderate pulpitis.
• Radiographic finding of periapical index (PAI) score ≤2.
• Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit).
• Pulp exposure after complete caries excavation.
• No pulp exposure after incomplete caries excavation

You may not qualify if:

• Teeth with immature roots.
• Pulp exposure after incomplete caries excavation.
• No pulp exposure after complete caries excavation.
• Bleeding could not be controlled in 5 minutes.
• Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure.
• History of analgesic intake in previous 1 week, or antibiotic intake in 1 month.
• Internal/external resorption.
• Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine)

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS, Rohtak

Rohtak, Haryana, India

RECRUITING

Study Officials

• Dr, Sanjay Tewari, MDS

  PGIDS, Rohtak, Haryana, 124001

  STUDY DIRECTOR

Central Study Contacts

Dr. Vinay Kumar, MDS

CONTACT

8901149107; 29vinaykr@gmail.com

Dr. Soma Chanakya, MDS

CONTACT

7396287866; Chanakyasoma5@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Considering the nature of intervention, masking of the operator will not be possible once he begins the caries removal. Patients will be unaware of the groups in which their allocation will take place. At the time of assessing data masking will be done by masking the entire crown of the tooth before evaluation by endodontist using Adobe Photoshop CS6.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: May 23, 2024
• Primary Completion: March 23, 2026
• Study Completion: March 23, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-01

Locations

IN (1)