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).
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
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.
- Conditions
- Pulp Exposure, Dental
- 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.
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)
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.
- First posted31 May 2022
- Study start15 Mar 2024
- Primary completion30 Apr 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulp Exposure, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Ozturk Bozkurt, Istanbul Medipol University Hospital
- Investigators
- Funda Öztürk Bozkurt, Principal investigator, fbozkurt@medipol.edu.tr
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 20166407Al-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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of the Results of Direct Pulp Capping Treatment
- ClinicalTrials.gov ID
- NCT05397964
- Acronym / sponsor ID
- 362
- Conditions
- Pulp Exposure, Dental
- Keywords
- direct pulp capping,, calcium hydroxide liner
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Has to be one of the patients treated with calcium hydroxide as direct pulp capping
Key exclusion criteria (1 listed)
- Patients (treated with calcium hydroxide as direct pulp capping) who will not be available for the recall appointment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiopaque Calcium Hydroxide CompositionTreatment of exposed pulp tissue with radiopaque calcium hydroxide composition as a direct pulp capping material | Device | – |
Primary outcome
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
1 secondary outcome
Evaluation of the restorations with FDI,World Dental Federation - clinical criteria for the evaluation of direct restorations.
Time frame: up to 11 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 20166407Miles 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.
- Background: PubMed 17138715Al-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Funda Öztürk Bozkurt principal investigator
fbozkurt@medipol.edu.tr
1 site in 1 country: see every site and its status.
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.