Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis

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

Study Overview

• Status: Not yet recruiting
• Conditions: Reversible Pulpitis; Extremely Deep Caries
• Intervention / Treatment: Procedure: Direct pulp capping with MTA; Procedure: Partial Pulpotomy in Reversible Pulpitis

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Pankaj Sangwan, MDS; Phone Number: 9996112202; Email: drps_1@yahoo.co.in
• Study Contact Backup: Name: Dr. Prerna Yadav, PG student; Phone Number: 9763276071; Email: viks0267@gmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • PGIDS Rohtak
      • Contact: Dr. Pankaj Sangwan, MDS; Phone Number: 9996112202; Email: drps_1@yahoo.co.in
      • Contact: Dr. Prerna Yadav, PG student; Phone Number: 9763276071; Email: viks0267@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate at 1 year	Criteria for success:- Clinical: Absence of signs and symptoms of spontaneous pain or pain on stimulus and discomfort except for the first few days after treatment.; No tenderness to palpation or percussion and the tooth is functional.; Normal mobility and probing pocket depth.; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	Post Operative Pain- To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score100 means maximum pain. To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain.	Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Dr. Pankaj Sangwan, MDS, PGIDS, Rohtak, Haryana 124001

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 10, 2027

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Direct pulp capping; Partial Pulpotomy
• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Pemetrexed
• Other Study ID Numbers: Pankaj Sangwan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No