COMPARATIVE EVALUATION OF DIRECT PULP CAPPING AND COMPLETE PULPOTOMY IN MATURE PERMANENT MANDIBULAR MOLARS WITH CLINICAL SIGNS INDICATIVE OF MODERATE PULPITIS

Last updated: June 2, 2024
Sponsor: Postgraduate Institute of Dental Sciences Rohtak
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute And Chronic Dental Pain

Treatment

Complete Pulpotomy

Direct pulp capping

Clinical Study ID

NCT06447753
Sakshi
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Title: Comparative evaluation of direct pulp capping and complete pulpotomy in mature permanent mandibular molars with clinical signs indicative of moderate pulpitis: Randomized Clinical Trial

Rationale: According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which are correspond to irreversible pulpitis.

Complete/partial pulpotomy are suggested to be the choice of treatment for such cases. It has been suggested that infection is often the cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Based on this premise, DPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of partial/complete pulpotomy in adults

Research Question Does Direct Pulp Capping have comparable outcome with complete pulpotomy in mature permanent teeth with clinical signs indicative of moderate pulpitis?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The patient should be ≥18 years of age. 2. Restorable mature permanent 1 st and 2ndMandibular molars with extremely deep caries (≥2/3 dentine involvement) 3. Toothshould give positive response to pulp sensibility testing. 4. Clinical diagnosis ofmoderate pulpitis. 5. Radiographic finding of periapical index (PAI) score ≤2. 6.Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit).

Exclusion

  • Exclusion Criteria:

  1. Teeth with immature roots.

  2. No pulp exposure after caries excavation.

  3. Bleeding could not be controlled in 6 minutes.

  4. Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulpexposure.

  5. History of analgesic intake in previous 1 week, or antibiotic intake in 1 month.

  6. Internal/external resorption.

  7. Contributory medical history (alcoholism, smokers, diabetic, hypertension, drugdependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV),infectious diseases, kidney or liver, migraine) -

Study Design

Total Participants: 92
Treatment Group(s): 2
Primary Treatment: Complete Pulpotomy
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
November 30, 2024

Study Description

Rationale: Vital pulp therapy has been traditionally recommended only in teeth with reversible pulpitis with no periapical pathologies or in teeth with either mechanical pulp exposure or recent traumatic exposure. Clinical symptoms such as characteristic, severity and intensity of pre-operative pain do not accurately talk about the status of the pulp inflammation and the depth of involvement. It has been demonstrated that there is no precise correlation between clinical symptoms and the histopathological status of the pulp, mainly in case of irreversible pulpitis, that might lead to a wrong diagnosis. Vitality tests such as cold test or electric pulp tests reveal only whether the pulp is responsive to respective stimuli or not. According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which are correspond to irreversible pulpitis.

Complete/partial pulpotomy are suggested to be the choice of treatment for such cases. It has been suggested that infection is often the cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Based on this premise, DPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of partial/complete pulpotomy in adults

Aim: To compare the outcome of direct pulp capping and complete pulpotomy in mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.

Objectives:

  1. To evaluate the clinical and radiographic success of direct pulp capping in mature permanent molars with clinical signs indicative of moderate pulpitis.

  2. To evaluate the clinical and radiographic success of complete pulpotomy in mature permanent molars with clinical signs indicative of moderate pulpitis.

  3. To evaluate pain incidence and severity after direct pulp capping and complete pulpotomy in mature permanent molars with clinical signs indicative of moderate pulpitis

P (Population) - Mature Permanent Mandibular molars with clinical signs of moderate pulpitis I (Intervention) -Direct pulp capping C (Comparison) - Complete pulpotomy O (Outcome) - Assessment of clinical and radiographic success at 12 months follow up.

  • To assess incidence and reduction in pain post operatively at every 24 hours till 1 week

Connect with a study center

  • PGIDS

    Rohtak, Haryana 124001
    India

    Active - Recruiting

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