Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis

ConditionsReversible Pulpitis Extremely Deep Caries

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age15-40

SponsorPostgraduate Institute of Dental Sciences Rohtak

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Non restorable teeth

Negative response to vitality testing

Presence of sinus tract or soft tissue swelling

Absence of deep carious lesions radiographically

Trial design

Design model

Parallel

Treatments tested in this trial

Partial Pulpotomy in Reversible Pulpitis
Procedure/Surgery
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/Surgery
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.

Treatment groups

138 Participants

are divided into 2 treatment groups

Group A: Direct Pulp Capping in Reversible PulpitisExperimental treatment 1 intervention

Group B: Partial Pulpotomy in Reversible PulpitisActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline to 12 months

Secondary outcomes

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.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Postgraduate Institute of Dental Sciences Rohtak

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: