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Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis

NCT ID: NCT07300124

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2027-12-10

Brief Summary

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AIM: -The aim of the study is to compare the outcome of Direct Pulp Capping and Partial Pulpotomy in mature permanent teeth with Reversible Pulpitis OBJECTIVES: - Primary Objective: to compare the difference in clinical and radiographic outcome of direct pulp capping and partial pulpotomy in mature permanent teeth with Reversible Pulpitis. Secondary objective: To evaluate and compare postoperative pain after Direct Pulp Capping and Partial Pulpotomy in teeth with Reversible Pulpitis STUDY GROUPS: - Subjects of age group 15 to 40 years will be included and divided into two groups

1. Direct Pulp Capping in Permanent mature molars with Reversible Pulpitis
2. Partial Pulpotomy in Permanent mature molars with Reversible Pulpitis

Detailed Description

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TITLE: Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis It aims to answer does outcome of direct pulp capping and partial pulpotomy differ in mature permanent teeth with extremely deep caries with reversible pulpitis. P (Population) - Mature permanent mandibular molars with extremely deep caries and clinical signs of reversible pulpitis. I (Intervention) -Direct Pulp Capping in teeth with Reversible Pulpitis. C (Comparison) -Partial Pulpotomy in teeth with Reversible Pulpitis. O (Outcome) -Assessment of clinical \& radiographic success at 6 and 12 months follow up -Assessment of pain experience at baseline, post-operatively every 24 hours for 1 week In extremely deep lesions, the dental pulp is often inflamed or at risk of microbial contamination, therefore requiring timely and precise intervention in order to preserve pulp vitality. In such cases, the removal of the superficial 2-3 mm of inflamed pulp tissue can help maintain the health of the remaining pulpal tissue. Duncan and other researchers have emphasized the importance of assessing both caries depth and pulpal status for deciding the effective treatment plan. Although numerous studies have investigated the outcomes of Direct Pulp Capping (DPC) and Partial Pulpotomy separately \& have included cases based on caries depth \& pulpal status, such as reversible pulpitis. However, there remains a notable lack of comparative clinical studies directly evaluating partial pulpotomy and direct pulp capping under standardized conditions involving extremely deep carious lesions with pulpal status as reversible pulpitis. Hence, this clinical trial aims to assess and compare the clinical and radiographic outcome of Direct Pulp Capping and Partial Pulpotomy in extremely deep caries with reversible pulpitis.

Conditions

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Reversible Pulpitis Extremely Deep Caries

Keywords

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Partial Pulpotomy Direct pulp capping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Direct Pulp Capping in Reversible Pulpitis

Direct Pulp Capping will be performed on carious pulp exposure after establishing a clinical diagnosis of symptomatic reversible pulpitis based on history of pain exacerbated by cold stimuli and subsides on removal of stimuli compared to normal teeth and which is reproducible using cold testing.

Group Type EXPERIMENTAL

Direct pulp capping with MTA

Intervention Type PROCEDURE

Outcome of direct pulp capping in teeth with clinical signs indicative of reversible pulpitis.

After caries removal and pulp exposure pulpal wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 to 3 minutes and will be repeated if required. Followed by capping with MTA, a layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin.

Partial Pulpotomy in Reversible Pulpitis

Partial Pulpotomy will be performed on carious pulp exposure after establishing a clinical diagnosis of symptomatic reversible pulpitis based on history of pain exacerbated by cold stimuli and subsides on removal of stimuli compared to normal teeth and which is reproducible using cold testing.

Group Type ACTIVE_COMPARATOR

Partial Pulpotomy in Reversible Pulpitis

Intervention Type PROCEDURE

Procedure/Surgery: Outcome of Partial Pulpotomy in teeth with clinical signs indicative of Reversible Pulpitis with extremely deep caries.

After caries removal and pulp exposure , 2-3 mm of pulp tissue will be amputated and the pulpal wound irrigated with 3% NaOCl. Bleeding will be controlled by placing a cotton pellet soaked in 3% NaOCl over the pulpal wound for 2-3 minutes, repeated if required. This will be followed by capping with a 2-3 mm layer of MTA in both the groups. A layer of RMGIC will then be placed over the MTA, and the tooth will be permanently restored with composite resin.

Interventions

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Partial Pulpotomy in Reversible Pulpitis

Procedure/Surgery: Outcome of Partial Pulpotomy in teeth with clinical signs indicative of Reversible Pulpitis with extremely deep caries.

After caries removal and pulp exposure , 2-3 mm of pulp tissue will be amputated and the pulpal wound irrigated with 3% NaOCl. Bleeding will be controlled by placing a cotton pellet soaked in 3% NaOCl over the pulpal wound for 2-3 minutes, repeated if required. This will be followed by capping with a 2-3 mm layer of MTA in both the groups. A layer of RMGIC will then be placed over the MTA, and the tooth will be permanently restored with composite resin.

Intervention Type PROCEDURE

Direct pulp capping with MTA

Outcome of direct pulp capping in teeth with clinical signs indicative of reversible pulpitis.

After caries removal and pulp exposure pulpal wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 to 3 minutes and will be repeated if required. Followed by capping with MTA, a layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients aged 15-40 years.
2. Mature permanent mandibular molars with extremely deep caries on radiograph, giving positive response to pulp sensibility test.
3. Pulpal bleeding can be controlled within 10 minutes
4. Patients having normal periapical status with periapical index (PAI) score ≤ 2
5. Periodontally healthy teeth
6. Positive response to pulp sensibility test

Exclusion Criteria

1. Non restorable teeth
2. Negative response to vitality testing
3. Presence of sinus tract or soft tissue swelling
4. Absence of deep carious lesions radiographically
5. Radiographic signs of internal or external root resorption
6. Patient had moderate to severe pain, but preferred root canal treatment
7. Presence of sound dentin over pulp and pulp not exposed intraoperatively
8. Pulp haemorrhage could not be arrested within 10 minutes.
9. Necrotic pulp evident upon exposure
10. Pregnant women
11. Absence of antagonist teeth
12. Intake of antibiotics in last 30 days
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Pankaj Sangwan, MDS

Role: PRINCIPAL_INVESTIGATOR

PGIDS, Rohtak, Haryana 124001

Locations

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PGIDS Rohtak

Rohtak, Haryana, India

Site Status

Countries

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India

Central Contacts

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Dr. Pankaj Sangwan, MDS

Role: CONTACT

Phone: 9996112202

Email: [email protected]

Dr. Prerna Yadav, PG student

Role: CONTACT

Phone: 9763276071

Email: [email protected]

Facility Contacts

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Dr. Pankaj Sangwan, MDS

Role: primary

Dr. Prerna Yadav, PG student

Role: backup

Other Identifiers

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Pankaj Sangwan

Identifier Type: -

Identifier Source: org_study_id