Ignite Creation Date:
2024-05-06 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05222243
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2021-12-08
Brief Title:
DPC in Primary Molars
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Evaluation of Calcium Hydroxide Paste Mineral Trioxide Aggregate and Formocresol as A Direct Pulp Capping in Primary Molars Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2018-07
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:
None
Brief Summary:
To evaluate clinical and radiographical outcomes of direct pulp capping using calcium hydroxide CH mineral trioxide aggregate MTA and premedicated direct pulp capping PDPC with formocresol FC in primary teeth
Detailed Description:
The pulp is imperiled by many environmental impacts Caries trauma restorations and mechanical injury during cleaning all are possible aggressions that may injury the pulp tissue When lesion disrupt enamel barrier dentin can be degraded by Gram-positive bacteria such as actinomyces lactobacilli and streptococci that largely dominate the microflora of carious lesion Pulp response differs according to the degree of the insult The inflammatory reaction can cause permanent damage or be followed by repair as the pulp cells have the ability to differentiate into odontoblasts forming dentin matrix facilitating wound healing
Calcium hydroxide was introduced to the dental practice in the 1920s and early clinical studies using it in direct pulp capping showed an 80-90 percent success rateRecent studies with longer follow-up periods suggest lower success rates for itCalcium hydroxide was used in many forms alone and mixed with other materials for many applications in the dental profession For direct pulp capping calcium hydroxide powder and aqueous paste were used at first then premixed and cement-based types were developed
Mineral trioxide aggregate MTA was introduced to the dental practice in the 1990s as a root-end filling material MTA is used as a gold standard in endodontics and has a variety of applications such as root-end filling apexification root and truck perforations apexogenesis pulp capping in permanent and primary teeth and dressing for pulpotomy in primary teeth It is mainly composed of tricalcium silicate tricalcium aluminate dicalcium silicate bismuth oxide and calcium sulfate dehydrate
Several studies have shown the efficacy of direct pulp capping using calcium hydroxide and MTA in permanent teeth However its use in primary teeth is controversial and few studies are available regarding that subject Formocresol is not known to be used in direct pulp capping techniques however its high clinical success in pulpotomy techniques for primary teeth promoted the investigation of its possible use as direct capping medicament In addition there are not enough collected clinical and histological data about direct capping in primary teeth to assess the true success of treatment Accordingly the study was directed to evaluate the histological and clinical success of different materials in direct pulp capping for primary teeth
Calcium hydroxide was introduced to the dental practice in the 1920s and early clinical studies using it in direct pulp capping showed an 80-90 percent success rateRecent studies with longer follow-up periods suggest lower success rates for itCalcium hydroxide was used in many forms alone and mixed with other materials for many applications in the dental profession For direct pulp capping calcium hydroxide powder and aqueous paste were used at first then premixed and cement-based types were developed
Mineral trioxide aggregate MTA was introduced to the dental practice in the 1990s as a root-end filling material MTA is used as a gold standard in endodontics and has a variety of applications such as root-end filling apexification root and truck perforations apexogenesis pulp capping in permanent and primary teeth and dressing for pulpotomy in primary teeth It is mainly composed of tricalcium silicate tricalcium aluminate dicalcium silicate bismuth oxide and calcium sulfate dehydrate
Several studies have shown the efficacy of direct pulp capping using calcium hydroxide and MTA in permanent teeth However its use in primary teeth is controversial and few studies are available regarding that subject Formocresol is not known to be used in direct pulp capping techniques however its high clinical success in pulpotomy techniques for primary teeth promoted the investigation of its possible use as direct capping medicament In addition there are not enough collected clinical and histological data about direct capping in primary teeth to assess the true success of treatment Accordingly the study was directed to evaluate the histological and clinical success of different materials in direct pulp capping for primary teeth
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