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Not yet recruiting NCT07300124

Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis

No phase Interventional Reversible Pulpitis Extremely Deep Caries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Partial Pulpotomy in Reversible Pulpitis, Direct pulp capping with MTA.
Who it may be relevant to
Registry conditions: Reversible Pulpitis, Extremely Deep Caries. Basic parameters: 15 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

  • 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 w
  • 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.

Primary outcome measures

  • Success rate at 1 year [Time frame: Baseline to 12 months]
Secondary outcome measures (1)
  • Postoperative Pain [Time frame: Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

India · 1 center
  • PGIDS Rohtak — Rohtak

Identifiers

NCT: NCT07300124 · Pankaj Sangwan

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗