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NCT Number: NCT07300124

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

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Key information

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Success rate at 1 year

    Time frame: Baseline to 12 months

    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: -
    • 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.

Secondary outcomes

  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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Pankaj Sangwan, MDS

CONTACT

[email protected]

9996112202

Dr. Prerna Yadav, PG student

CONTACT

[email protected]

9763276071

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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