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Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis

NCT07300124 · tracked via the Priya Life Science India tracker
Phase
Not applicable
Started
2025-12-10
Last updated
2025-12-23

Condition(s) studied

Reversible PulpitisExtremely Deep Caries

Investigational drug(s) / intervention(s)

Partial Pulpotomy in Reversible PulpitisDirect pulp capping with MTA

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.

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.

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

Eligibility

Sex
ALL
Min age
15 Years
Max age
40 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Success rate at 1 year — Baseline to 12 months
    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.

Trial sites (1)

FacilityCityRegionStatus
PGIDS Rohtak Rohtak Haryana
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07300124 on ClinicalTrials.gov ↗ ← All trials in India