Viewing Study NCT05878249



Ignite Creation Date: 2024-05-06 @ 7:02 PM
Last Modification Date: 2024-10-26 @ 2:59 PM
Study NCT ID: NCT05878249
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2023-12-08
First Post: 2023-05-05

Brief Title: Role Of Wound Lavage in Direct Pulp Capping Of Permanent Teeth With Carious Exposure
Sponsor: Postgraduate Institute of Dental Sciences Rohtak
Organization: Postgraduate Institute of Dental Sciences Rohtak

Study Overview

Official Title: Role Of Wound Lavage in Direct Pulp Capping Of Permanent Teeth With Carious Exposure A Randomized Controlled Trial
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2023-05
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: the purpose of the study is to investigate the outcome of wound lavage agents Sodium hypochlorite and Ethylenediaminetetraacetic acid EDTA in direct pulp capping of mature permanent teeth with carious exposure
Detailed Description: With the growth of advanced pulp biology and bioactive materials today management of deep carious lesions has come to a more conservative approach Vital pulp therapy VPT comprising direct pulp capping partial pulpotomy and coronal pulpotomy has been proposed as an alternative treatment to the traditional root canal treatment Although there seems to be an agreement on the appropriate pulp dressing materials the recommended irrigant for VPT in permanent teeth is less studied Dentin matrix is a reservoir of bioactive molecules that are sequestered during dentinogenesisThe releasable growth factors from dentine provide source of cell signaling molecules for initiating repair and regeneration Evidence shows that EDTA has ability to release growth factors from dentine matrix and it also promotes cell survivalattachmentgrowth and differentiation Sodium hypochlorite has high efficacy against biofilms and its semi selective tissue dissolving properties on necrotic rather than vital soft tissue makes it ideal for dentinpulp wound lavageIn direct pulp capping wound lavage with sodium hypochlorite has shown to reduce postoperative pain and early painful failures However there is a lack of well designed clinical trials on pulp wound lavage

The aim of this study is to investigate the outcome of wound lavage agents Sodium hypochlorite and EDTA in direct pulp capping of mature permanent posterior teeth with carious exposure Study will be conducted in Post Graduate Institute of Dental Sciences Rohtak in department of Conservative Dentistry EndodonticsTime Frame of the study will be 18 months and Patients of age 18-50 years will be enrolled in this study

After caries excavation patients will be randomly allocated into four groups- Group I-normal saline Group II-sodium hypochlorite Group III-EDTA Group IV-Sodium hypochlorite followed by EDTA Washing of the pulp wound will be done with respective allocated solution and then tooth in both groups will be restored according to standard protocol

Primary outcome variables recorded will be clinical and radiographic success rates after 6 and 12 months from the treatment

Secondary outcome measure will be reduction in post operative pain after 7days of the treatment

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