Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447753
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-02
Brief Title:
COMPARATIVE EVALUATION OF DIRECT PULP CAPPING AND COMPLETE PULPOTOMY IN MATURE PERMANENT MANDIBULAR MOLARS WITH CLINICAL SIGNS INDICATIVE OF MODERATE PULPITIS
Sponsor:
Postgraduate Institute of Dental Sciences Rohtak
Organization:
Postgraduate Institute of Dental Sciences Rohtak
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Completepartial 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 ie 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 partialcomplete 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
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
Completepartial 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 ie 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 partialcomplete 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
Detailed 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
Completepartial 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 ie 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 partialcomplete 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
Completepartial 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 ie 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 partialcomplete 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None