Comparative Evaluation of Indirect vs. Direct Pulp Capping in Deep Carious Mandibular Molars

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPostgraduate Institute of Dental Sciences Rohtak

About this trial

Aim: To compare the outcome of indirect and direct pulp capping after partial or complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.

Objectives:

1. To evaluate the clinical and radiographic success of indirect pulp capping after partial caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis. 2. To evaluate the clinical and radiographic success of direct pulp capping after complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis. 3. To evaluate pain incidence and severity after indirect and direct pulp capping after partial and complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The patient should be ≥18 years of age.

Restorable mature permanent 1st and 2nd Mandibular molars with deep caries (reaching inner quarter of dentine)

Tooth should give positive response to pulp sensibility testing.

Clinical diagnosis of moderate pulpitis.

Disqualifiers

Teeth with immature roots.

Pulp exposure after incomplete caries excavation.

No pulp exposure after complete caries excavation.

Bleeding could not be controlled in 5 minutes.

Trial design

Design model

Parallel

Treatments tested in this trial

  • INDIRECT AND DIRECT PULP CAPPING AFTER PARTIAL OR COMPLETE CARIES REMOVAL IN DEEPLY CARIOUS MATURE PERMANENT MANDIBULAR MOLARS WITH MODERATE PULPITIS

    Procedure/Surgery

    After partial caries removal the cavity is disinfected, dried, and capped with a 2-3mm layer of MTA followed by a light-cured resin layer. The tooth is then definitively restored with composite. Following complete caries removal, any bleeding pulp will be controlled with sodium hypochlorite for up to 5 minutes. Exposed pulp will then be directly capped with a 2-3mm layer of MTA, followed by a light-cured resin layer and definitive composite restoration using an etch-and-rinse technique.

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Partial caries removal followed by Indirect pulp capping.Experimental treatment 1 intervention
Group B: Complete caries removal followed by Direct Pulp CappingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Success Rate

No pain or discomfort. No tenderness to palpation or percussion. Normal mobility and probing pocket depth.

Time frame
12 months
2

Radiographic success

No pathology on the radiograph.

Time frame
12 months

Secondary outcomes

1

Pain reduction

Post operative pain To assess pain postoperatively at every 24 hours till 7 days using Visual analogue Scale.

Time frame
Seven days

Other outcomes

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