Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis

NCT07300124 | Not Yet Recruiting

• 1 other identifier: Pankaj Sangwan
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Reversible Pulpitis; Extremely Deep Caries

Keywords

Partial Pulpotomy; Direct pulp capping

Outcome Measures

Primary Outcomes (1)

• Success rate at 1 year

  Criteria for success:- Clinical: 1. Absence of signs and symptoms of spontaneous pain or pain on stimulus and discomfort except for the first few days after treatment. 2. No tenderness to palpation or percussion and the tooth is functional. 3. Normal mobility and probing pocket depth. 4. Absence of associated soft tissue swelling, sinus or fistula. Radiographic: - 1\. Absence of any periapical or interradicular radiolucency. 2. Complete radiographic healing (PAI score 1 or 2 acc. to Ostravik et al). 3. Absence of internal and external root resorption Tooth will be considered successful when all the above parameters are met.

  Baseline to 12 months

Secondary Outcomes (1)

• Postoperative Pain

  Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment

Study Arms (2)

Direct Pulp Capping in Reversible Pulpitis

EXPERIMENTAL

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.

Procedure: Direct pulp capping with MTA

Partial Pulpotomy in Reversible Pulpitis

ACTIVE COMPARATOR

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.

Procedure: Partial Pulpotomy in Reversible Pulpitis

Interventions

Direct pulp capping with MTA 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.

Direct Pulp Capping in Reversible Pulpitis

Partial Pulpotomy in Reversible Pulpitis 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.

Partial Pulpotomy in Reversible Pulpitis

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS Rohtak

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Interventions

Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Dr. Pankaj Sangwan, MDS

  PGIDS, Rohtak, Haryana 124001

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Pankaj Sangwan, MDS

CONTACT

9996112202; drps_1@yahoo.co.in

Dr. Prerna Yadav, PG student

CONTACT

9763276071; viks0267@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

IN (1)