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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?


Clinical Trial 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 ;


Study Design


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NCT number NCT06447753
Study type Interventional
Source Postgraduate Institute of Dental Sciences Rohtak
Contact Vinay Kumar, MDS
Phone 8901149107
Email 29vinaykr@gmail.com
Status Recruiting
Phase N/A
Start date June 1, 2023
Completion date November 30, 2024