Ignite Creation Date:
2024-05-06 @ 9:47 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03071588
Status:
UNKNOWN
Last Update Posted:
2018-03-07
First Post:
2017-02-23
Brief Title:
Assessment of a New Protocol for Indirect Pulp Capping Procedures
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Assessment of a New Protocol for Indirect Pulp Capping Procedures
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 aim of the study is to assess clinically radiographically and microbiologically a new protocol for indirect pulp capping procedures compared to the conventional protocol in painful teeth It was postulated that there is no difference between both protocols in terms clinical radiographical and microbial outcome measure after one year of follow up in painful teeth
Detailed Description:
Indirect pulp capping is a common dental procedure carried out on painful teeth with deep cavities resulting from dental decay in an attempt to prolong the life of the tooth pulp while relieving pain This study aims primarily to assess the response of the pulp of the tooth to two different clinical procedures used in the treatment of deep caries One group of patients will be treated with a standard clinical procedure which involve mechanical rotary burs with no magnification for caries removal the other group will be treated with a more conservative clinical procedure using CarisolvTM gel with the aid of an operating microscope for caries removal The study also involves taking of samples from the tooth decay for microbiological biochemical analysis and evaluation to determine the species richness in the bacterial community associated with this condition The study also compare the radiographical findings of 3D cone beam computed tomography CBCT scans with that of normal Xrays in detecting the presence of early bone changes associated with the roots of these teeth
The study carried out at Kings College London Dental Institute at Guys Hospital and form part of the routine dental treatment done at the emergency dental clinics with the exception of the CBCT scans Volunteers given written information about the process and given time to consider participation Once any questions have been answered fully informed written consent obtained if they are interested in taking part At least one deep cavity causing toothache requiring indirect pulp capping detected and diagnosed through conventional clinical and Xray dental assessment The procedure involves removal of the decay using one of the proposed clinical techniques and the placement of a pulp capping material according to manufacturers instructions and the definitive filling will be placed follow up will at 12 months Radiographic assessment including cone beam computed tomography CBCT will be done at baseline and 12 months It is hoped that data analysed from this study will provide a definitive clinical and radiographic evidence base for the outcome of the indirect pulp capping operative treatment procedure
The study carried out at Kings College London Dental Institute at Guys Hospital and form part of the routine dental treatment done at the emergency dental clinics with the exception of the CBCT scans Volunteers given written information about the process and given time to consider participation Once any questions have been answered fully informed written consent obtained if they are interested in taking part At least one deep cavity causing toothache requiring indirect pulp capping detected and diagnosed through conventional clinical and Xray dental assessment The procedure involves removal of the decay using one of the proposed clinical techniques and the placement of a pulp capping material according to manufacturers instructions and the definitive filling will be placed follow up will at 12 months Radiographic assessment including cone beam computed tomography CBCT will be done at baseline and 12 months It is hoped that data analysed from this study will provide a definitive clinical and radiographic evidence base for the outcome of the indirect pulp capping operative treatment procedure
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