Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495242
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-02
Brief Title:
Direct Pulp Capping Compared to Partial Pulpotomy in Carious Pulp Exposures
Sponsor:
King Abdullah University Hospital
Organization:
King Abdullah University Hospital
Study Overview
Official Title:
Outcome of Direct Pulp Capping Compared to Partial Pulpotomy in the Management of Carious Pulp Exposures in Mature Teeth A Randomized Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
Pulp cap
Brief Summary:
This a prospective randomized clinical trial that compare vital pulp therapy procedures in permanent teeth with carious pulp exposure Patients are recruited from the dental teaching clinics at JUST following preset inclusion criteria They are subsequently randomly assigned to one of treatment procedures Clinical and radiographic follow up is performed after 6 months and yearly up to 5 years
Detailed Description:
Background Deep carious lesions are commonly encountered in both adults and children with no clear consensus on the ideal clinical management Vital pulp therapy including direct pulp capping and pulpotomy is increasingly considered in the management of carious pulp exposures when the clinical diagnosis is reversible pulpitis with variable reports of success rates with different materials used and different diagnostic categories
Aims The aims of this study are to evaluate the clinical and radiographic outcomes of direct pulp capping and partial pulpotomy in deep carious lesions of mature permanent teeth using a calcium silicate based material Biodentine Septodont France and to investigate the relationship between matrix metalloproteinase MMP 9 levels in the pulpal blood and the outcome of these procedures
Methods 120 mature molar teeth in 120 patients with deep carious lesions exposing the pulps on the radiograph and with symptoms of reversible pulpitis will be included in the study The teeth will be subsequently randomly divided into 2 groups n60 One group will receive direct pulp capping and composite restoration and the second group will receive partial pulpotomy and composite restoration Pulpal blood will be collected from the exposure site and will be tested for the level of MMP9 using special ElISA kit Preoperative and postoperative pain level at 48 hours and 7 days will be evaluated on a scale from 0-10
The treated teeth will be further evaluated clinically and radiographically at 6 and 12 months follow up and yearly afterward The relationship of the outcome to the level of MMP9 will be investigated The results will be statistically analyzed using appropriate tests in the SPSS software
Expected results Since partial pulpotomy includes the removal of 2-3 mm of the exposed pulp tissue which is theoretically inflamed it is expected to be more effective in alleviating the patients symptoms and to have a higher success rate than simply pulp capping the carious exposure High levels of MMP9 are also expected to have a correlation with the failure rate
Aims The aims of this study are to evaluate the clinical and radiographic outcomes of direct pulp capping and partial pulpotomy in deep carious lesions of mature permanent teeth using a calcium silicate based material Biodentine Septodont France and to investigate the relationship between matrix metalloproteinase MMP 9 levels in the pulpal blood and the outcome of these procedures
Methods 120 mature molar teeth in 120 patients with deep carious lesions exposing the pulps on the radiograph and with symptoms of reversible pulpitis will be included in the study The teeth will be subsequently randomly divided into 2 groups n60 One group will receive direct pulp capping and composite restoration and the second group will receive partial pulpotomy and composite restoration Pulpal blood will be collected from the exposure site and will be tested for the level of MMP9 using special ElISA kit Preoperative and postoperative pain level at 48 hours and 7 days will be evaluated on a scale from 0-10
The treated teeth will be further evaluated clinically and radiographically at 6 and 12 months follow up and yearly afterward The relationship of the outcome to the level of MMP9 will be investigated The results will be statistically analyzed using appropriate tests in the SPSS software
Expected results Since partial pulpotomy includes the removal of 2-3 mm of the exposed pulp tissue which is theoretically inflamed it is expected to be more effective in alleviating the patients symptoms and to have a higher success rate than simply pulp capping the carious exposure High levels of MMP9 are also expected to have a correlation with the failure rate
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