Retrospective Evaluation of the Results of Direct Pulp Capping Treatment

July 9, 2024 updated by: Funda Ozturk Bozkurt, Istanbul Medipol University Hospital
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 1/3 of the relevant tooth for 2-3 seconds.Sensitivity 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 she/he 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 Type

Observational

Enrollment (Estimated)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34083
        • Istanbul Medipol University, Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The population of the study group consists of a dentist's patients that have been treated with calcium hydroxide as direct pulp capping between 2011-2020.

Description

Inclusion Criteria:

  • Has to be one of the patients treated with calcium hydroxide as direct pulp capping

Exclusion Criteria:

  • Patients (treated with calcium hydroxide as direct pulp capping) who will not be available for the recall appointment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with pulp capping treatment-related adverse events as assessed by vitality tests and intra-oral examination
Time Frame: up to 11 years
Vitality tests (cold, electrical pulp test) and radiographical examination
up to 11 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the restorations with FDI,World Dental Federation - clinical criteria for the evaluation of direct restorations.
Time Frame: up to 11 years
The restorations will be evaluated for biological, esthetic and functional parameters as clinically acceptalbe and nonacceptable.
up to 11 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: Funda Öztürk Bozkurt, fbozkurt@medipol.edu.tr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2024

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 362

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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