Deep Dentin Caries in Primary TeethNCT07382115
Indirect and Direct Pulp Therapy in Primary Second Molars
A study testing Indirect Pulp Treatment and Direct Pulp Capping in people with Deep Dentin Caries in Primary Teeth and Pulp Therapy in Primary Molars, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this randomized controlled clinical trial was to compare the clinical and radiographic outcomes of indirect pulp treatment (IPT) and direct pulp capping (DPC) using mineral trioxide aggregate (MTA) in deep carious primary molars. Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Deep Dentin Caries in Primary Teeth, Pulp Therapy in Primary Molars
- What is being tested?
- Indirect Pulp Treatment and Direct Pulp Capping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2019to 30 Apr 2020
- Phase
- Interventional
- 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 7 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Systemically healthy children aged 7 to 9 years
- Primary second molars with deep dentin caries indicated for vital pulp therapy
- Absence of clinical signs or symptoms of irreversible pulpitis
- No spontaneous or prolonged pain
- Teeth with no tenderness to percussion or palpation
- No pathological mobility, swelling, fistula, or abscess
Show all 11Show fewer
- Radiographic findings showing intact lamina dura and normal periodontal ligament space
- Absence of periapical or furcation radiolucency
- No evidence of pathological internal or external root resorption
- Teeth considered restorable
- Written informed consent obtained from parents
Who cannot join
- Children with systemic diseases or medical conditions affecting healing
- Teeth with signs or symptoms of irreversible pulpitis
- Presence of spontaneous pain, night pain, or prolonged pain
- Teeth with periapical or furcation radiolucency
- Teeth with pathological internal or external root resorption
- Presence of pulpal calcifications or pulp stones
- Non-restorable teeth
- Lack of parental consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Dentistry
Ankara, Ankara
About this study
Official title: Clinical and Radiographic Comparison of Indirect Pulp Treatment and Direct Pulp Capping in Deep Carious Primary Second Molars: One-Year Results
The purpose of this randomized controlled clinical trial was to compare the clinical and radiographic outcomes of indirect pulp treatment (IPT) and direct pulp capping (DPC) using mineral trioxide aggregate (MTA) in deep carious primary molars. Children with deep dentin caries in primary molars were randomly assigned to receive either IPT or DPC. Clinical and radiographic evaluations were performed at 6 and 12 months to assess treatment success. The findings of this study aim to provide evidence-based guidance for the management of deep dentin caries in primary teeth.
- Being tested
- Indirect Pulp Treatment, Direct Pulp Capping
- Keywords
- indirect pulp treatment, direct pulp capping, Mineral trioxide aggregate, Randomized controlled trial, Primary second molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect Pulp TreatmentProcedure or surgery
Selective caries removal was performed, leaving affected dentin over the pulp. Mineral trioxide aggregate (MTA) was placed, followed by restoration with a stainless steel crown (SSC).
Direct Pulp CappingProcedure or surgery
After <1 mm pulp exposure, mineral trioxide aggregate (MTA) was placed directly over the exposed pulp tissue, followed by restoration with a stainless steel crown (SSC).
| Study group | Role | What they receive |
|---|---|---|
| Indirect Pulp Treatment (IPT) | Experimental | Teeth allocated to this arm received indirect pulp treatment. Selective caries removal was performed, leaving affected dentin over the pulp, followed by placement of mineral trioxide aggregate (MTA) and restoration with a stainless steel crown (SSC). Receives: Procedure: Indirect Pulp Treatment |
| Direct Pulp Capping (DPC) | Experimental | Teeth allocated to this arm received direct pulp capping. After <1 mm pulp exposure, mineral trioxide aggregate (MTA) was placed directly over the exposed pulp tissue, followed by restoration with a stainless steel crown (SSC). Receives: Procedure: Direct Pulp Capping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success of indirect pulp treatment and direct pulp capping
Clinical success was defined as the absence of spontaneous pain, swelling, fistula, pathological mobility, or tenderness to percussion.
Measured: 12 months
Radiographic success of indirect pulp treatment and direct pulp capping
Radiographic success was defined as the absence of periapical radiolucency, internal or external root resorption, pathological changes, or other radiographic signs of pulpal or periapical pathology during the follow-up period.
Measured: 12 months
Secondary outcomes (1)
Effect of pulp exposure location on treatment success
The location of pulp exposure (occlusal or proximal) was recorded and its association with clinical and radiographic success of vital pulp therapy was evaluated.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start30 Apr 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Dentin Caries in Primary TeethStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Beren SATILMIS, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382115
- Sponsor's protocol ID
- 07/07
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaya S, Satilmis OB, Cihan AI, Oz FT. Clinical and radiographic outcomes of indirect pulp treatment and direct pulp capping using MTA in deeply carious primary second molars: a 12-month prospective study. BMC Oral Health. 2026 Jul 16;26(1):1273. doi: 10.1186/s12903-026-08821-6.
PubMed 42464216
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Comparison of Indirect Pulp Treatment and Direct Pulp Capping in Deep Carious Primary Second Molars: One-Year Results
- ClinicalTrials.gov ID
- NCT07382115
- Acronym / sponsor ID
- 07/07
- Keywords
- indirect pulp treatment, direct pulp capping, Mineral trioxide aggregate, Randomized controlled trial, Primary second molars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 2 Feb 2026 (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 purpose of this randomized controlled clinical trial was to compare the clinical and radiographic outcomes of indirect pulp treatment (IPT) and direct pulp capping (DPC) using mineral trioxide aggregate (MTA) in deep carious primary molars. Children with deep dentin caries in primary molars were randomly assigned to receive either IPT or DPC. Clinical and radiographic evaluations were performed at 6 and 12 months to assess treatment success. The findings of this study aim to provide evidence-based guidance for the management of deep dentin caries in primary teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indirect Pulp Treatment (IPT) | Experimental | Procedure: Indirect Pulp TreatmentTeeth allocated to this arm received indirect pulp treatment. Selective caries removal was performed, leaving affected dentin over the pulp, followed by placement of mineral trioxide aggregate (MTA) and restoration with a stainless steel crown (SSC). |
| Direct Pulp Capping (DPC) | Experimental | Procedure: Direct Pulp CappingTeeth allocated to this arm received direct pulp capping. After <1 mm pulp exposure, mineral trioxide aggregate (MTA) was placed directly over the exposed pulp tissue, followed by restoration with a stainless steel crown (SSC). |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Systemically healthy children aged 7 to 9 years
- Primary second molars with deep dentin caries indicated for vital pulp therapy
- Absence of clinical signs or symptoms of irreversible pulpitis
- No spontaneous or prolonged pain
- Teeth with no tenderness to percussion or palpation
Key exclusion criteria (8 listed)
- Children with systemic diseases or medical conditions affecting healing
- Teeth with signs or symptoms of irreversible pulpitis
- Presence of spontaneous pain, night pain, or prolonged pain
- Teeth with periapical or furcation radiolucency
- Teeth with pathological internal or external root resorption
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 |
|---|---|---|
| Indirect Pulp TreatmentSelective caries removal was performed, leaving affected dentin over the pulp. Mineral trioxide aggregate (MTA) was placed, followed by restoration with a stainless steel crown (SSC). | Procedure or surgery | Indirect Pulp Treatment (IPT) |
| Direct Pulp CappingAfter <1 mm pulp exposure, mineral trioxide aggregate (MTA) was placed directly over the exposed pulp tissue, followed by restoration with a stainless steel crown (SSC). | Procedure or surgery | Direct Pulp Capping (DPC) |
Primary outcome
Clinical success of indirect pulp treatment and direct pulp capping
Time frame: 12 months
Clinical success was defined as the absence of spontaneous pain, swelling, fistula, pathological mobility, or tenderness to percussion.
Radiographic success of indirect pulp treatment and direct pulp capping
Time frame: 12 months
Radiographic success was defined as the absence of periapical radiolucency, internal or external root resorption, pathological changes, or other radiographic signs of pulpal or periapical pathology during the follow-up period.
1 secondary outcome
Effect of pulp exposure location on treatment success
Time frame: 12 months
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 2 Feb 2026.
- Derived from this study: PubMed 42464216Kaya S, Satilmis OB, Cihan AI, Oz FT. Clinical and radiographic outcomes of indirect pulp treatment and direct pulp capping using MTA in deeply carious primary second molars: a 12-month prospective study. BMC Oral Health. 2026 Jul 16;26(1):1273. doi: 10.1186/s12903-026-08821-6.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect Pulp Treatment and Direct Pulp Capping in people with Deep Dentin Caries in Primary Teeth and Pulp Therapy in Primary Molars, run by Ankara University 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 11 inclusion and 8 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 2 Feb 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?
Clinical success of indirect pulp treatment and direct pulp capping (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT07382115, which also lists 1 linked publication.
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 2 Feb 2026.