Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433297
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-22
Brief Title:
Comparative Evaluation of Indirect vs Direct Pulp Capping in Deep Carious Mandibular Molars
Sponsor:
Postgraduate Institute of Dental Sciences Rohtak
Organization:
Postgraduate Institute of Dental Sciences Rohtak
Study Overview
Official Title:
Comparative Evaluation of Indirect and Direct Pulp Capping After Partial or Complete Caries Removal in Deeply Carious Mature Permanent Mandibular Molars With Moderate Pulpitis A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
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
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
Detailed Description:
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 characteristics 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 corresponds to irreversible pulpitis Vital pulp therapy is suggested to be the choice of treatment for such cases It has been suggested that infection is often a 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 Partial caries removal which involves complete removal of carious dentine from the surrounding cavity walls followed by the partial removal of infected dentin at the pulpal wall which reduce chances of pulp exposure followed by placement of medicament for Indirect pulp capping Whereas during Complete caries removal caries is completely removed from surrounding walls as well as on pulpal wall which increase the chances of pulp exposure followed by placement of medicament for Direct pulp capping procedure Based on this premise IPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of direct pulp capping partial pulpotomy or full pulpotomy in adults
Research Question Does Indirect Pulp Capping have comparable outcome with Direct pulp capping after partial caries removal in deeply carious mature permanent molars with clinical signs indicative of moderate pulpitis P Population - Deeply carious mature Permanent Mandibular molars with clinical signs indicative of moderate pulpitis I Intervention - Partial caries removal followed by Indirect pulp capping C Comparison - Complete caries removal followed by Direct pulp capping 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
Research Question Does Indirect Pulp Capping have comparable outcome with Direct pulp capping after partial caries removal in deeply carious mature permanent molars with clinical signs indicative of moderate pulpitis P Population - Deeply carious mature Permanent Mandibular molars with clinical signs indicative of moderate pulpitis I Intervention - Partial caries removal followed by Indirect pulp capping C Comparison - Complete caries removal followed by Direct pulp capping 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?:
None
Is an FDA AA801 Violation?:
None