Viewing Study NCT05397964



Ignite Creation Date: 2024-05-06 @ 5:41 PM
Last Modification Date: 2024-10-26 @ 2:33 PM
Study NCT ID: NCT05397964
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2024-07-10
First Post: 2022-05-11

Brief Title: Retrospective Evaluation of the Results of Direct Pulp Capping Treatment
Sponsor: Istanbul Medipol University Hospital
Organization: Istanbul Medipol University Hospital

Study Overview

Official Title: Retrospective Evaluation of the Results of Direct Pulp Capping Treatment
Status: ENROLLING_BY_INVITATION
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: None
Brief Summary: The aim of this retrospective study is to evaluate the vitality of teeth that had been treated with calcium hydroxide in direct pulp capping cases
Detailed Description: During restorative procedures pulp tissue may be exposed while caries is removed from deep dentin tissue There are some defense mechanisms to protect against bacterial invasion but the best barrier is provided by living pulp tissue During the life of a tooth living pulp tissue is responsible for the formation of secondary dentin peritubular dentin and repair dentin in response to biological or pathological stimuli Direct pulp capping means closing the exposed pulp tissue with the aim of healing Calcium hydroxide a biocompatible material has been used for many years in pulp capping with its ability to reduce bacterial infection and promote dentinopulpal remineralization However the results regarding the long-term clinical success of direct pulp capping with calcium hydroxide are conflicting After the calcium hydroxide application the restoration should be done with a filling material that can prevent the bacteria transfer between the restoration and the tooth tissue in the long term The success of the restoration has a significant impact on the healing and treatment outcome The aim of this study is to evaluate the clinical success of 217 direct capping treatments and restorations which were routinely applied to 190 patients in our clinic between 2011 and 2020

Individuals who were invited to the control session and approved to participate in the research with their signatures to evaluate the result of direct capping treatment will be examined by

Visual examination Related teeth and soft tissue will be examined
Palpation The apex of the related tooth will be palpated intra and extra orally
Percussion Percussion will be performed on the related tooth horizontally and vertically with a handpiece
Cold test Ethyl chloride Chloraethyl IGS AEROSOLS GMBH Baden Germany cold spray is applied to a small cotton pellet to the symmetrical tooth which is thought to be alive for control purposes and then to the cervical 13 of the relevant tooth for 2-3 secondsSensitivity will be asked A sensitive tooth will be considered to have responded positively to the cold test In the absence of sensitivity the tooth will be considered to have given a negative response
Electric pulp test For control purposes first the symmetrical tooth which is thought to be alive and then the related tooth will be tested with the Digitest Pulp Vitality Tester Parkell INC New York USA Before the test the teeth will be isolated from saliva with a cotton pad and toothpaste will be used as a conductive During the application the patient will be asked whether shehe has sensitivity In case of sensitivity the tooth will be deemed to have responded positively to the electrical pulp test and the relevant value will be recorded If there is no sensitivity the answer will be accepted as negative
Radiographic examination If swelling fistula inflammation or ulceration in the surrounding soft tissue is detected in the visual examination of the relevant tooth radiological evaluation will be made with periapical radiography If the patient has a panoramic radiograph obtained in the last 6 months for different treatment needs it will be used during the clinical examination Otherwise a periapical radiograph will be taken from the patient
The clinical performance of the restoration will be evaluated with the FDI criteria Where necessary digital camera restoration images will be taken

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