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Pulp Exposure, DentalNCT05397964

Retrospective Evaluation of the Results of Direct Pulp Capping Treatment

An observational study of Pulp Exposure, Dental, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Pulp Exposure, Dental
What is being tested?
Radiopaque Calcium Hydroxide Composition
Type of treatment
Medical device
How many people
190 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Mar 2024to 10 May 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Medipol University, Dental School

    Istanbul, 34083

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.
Being tested
Radiopaque Calcium Hydroxide Composition
Keywords
direct pulp capping,, calcium hydroxide liner
Medical subject headings
Dental Pulp Exposure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiopaque Calcium Hydroxide CompositionDevice

    Treatment of exposed pulp tissue with radiopaque calcium hydroxide composition as a direct pulp capping material

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with pulp capping treatment-related adverse events as assessed by vitality tests and intra-oral examination

    Vitality tests (cold, electrical pulp test) and radiographical examination

    Measured: up to 11 years

Secondary outcomes (1)
  1. Evaluation of the restorations with FDI,World Dental Federation - clinical criteria for the evaluation of direct restorations.

    The restorations will be evaluated for biological, esthetic and functional parameters as clinically acceptalbe and nonacceptable.

    Measured: up to 11 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2022
  2. Study start15 Mar 2024
  3. Primary completion30 Apr 2025
  4. Study completion10 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05397964
Sponsor's protocol ID
362
Status last verified
Nov 2026
First submitted
11 May 2022
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Miles JP, Gluskin AH, Chambers D, Peters OA. Pulp capping with mineral trioxide aggregate (MTA): a retrospective analysis of carious pulp exposures treated by undergraduate dental students. Oper Dent. 2010 Jan-Feb;35(1):20-8. doi: 10.2341/09-038CR1.

    PubMed 20166407
  • Al-Hiyasat AS, Barrieshi-Nusair KM, Al-Omari MA. The radiographic outcomes of direct pulp-capping procedures performed by dental students: a retrospective study. J Am Dent Assoc. 2006 Dec;137(12):1699-705. doi: 10.14219/jada.archive.2006.0116.

    PubMed 17138715

Questions about this trial

What is this clinical trial studying?

An observational study of Pulp Exposure, Dental, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05397964, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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