Deep Dentin Caries in Mature Permanent TeethNCT07120009
Partial Pulpotomy vs Selective Removing in Deep Caries
A study testing selective caries removal and partial pulpotpmy in people with Deep Dentin Caries in Mature Permanent Teeth, run by Cukurova University.
Trial summary
The aim of this study was to compare the one-year results of selective caries removal and partial pulpotomy treatments in terms of pulp survival and the need for further endodontic treatment in deep carious lesions.Individuals aged 18-65 years with medically healthy mature permanent teeth with deep caries will be… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Deep Dentin Caries in Mature Permanent Teeth
- What is being tested?
- selective caries removal and partial pulpotpmy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18-65
- ASA I or II general health status
- Deep primary or secondary caries lesion (up to 75% dentin thickness)
- Restorable permanent teeth with mature apex
- Teeth without clinical and radiographic periapical pathology
Who cannot join
- Pregnancy
- Periapical lesion
- Spontaneous pain or tenderness to palpation
- Teeth for which pulp opening or crown/root supported prosthesis is planned
- Localized severe periodontitis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Selective Caries Removal Versus Partial Pulpotomy in the Treatment of Deep Caries: A Randomized Controlled Trial
The aim of this study was to compare the one-year results of selective caries removal and partial pulpotomy treatments in terms of pulp survival and the need for further endodontic treatment in deep carious lesions.Individuals aged 18-65 years with medically healthy mature permanent teeth with deep caries will be included. The included teeth will be randomly assigned to the selective caries removal or partial pulpotomy group. Follow-up evaluations will be performed at 6 months and 12 months. The main outcome is pulp survival as determined by clinical and radiographic success.
- Being tested
- selective caries removal, partial pulpotpmy
- Keywords
- Vital pulp therapy, Deep caries, Selective caries removal, Partial pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective caries removalProcedure or surgery
The caries is not completely removed but covered with a remineralizing material. Its purpose is to maintain pulp vitality.
partial pulpotpmyProcedure or surgery
Complete cleaning of the caries resulting in pulp expose. pulp tissue is surgically removed by 1-3 mm.The aim is to remove the inflamed superficial pulp tissue to allow healing from the underlying healthy tissue.
| Study group | Role | What they receive |
|---|---|---|
| selective caries removal | Experimental | Deep caries lesions will be treated with selective caries removal and followed up Receives: Procedure: selective caries removal |
| partial pulpotomy | Experimental | Deep caries lesions will be treated with partial pulpotomy and followed up Receives: Procedure: partial pulpotpmy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain
Detailed medical history
- Is the pain constant or intermittent?
- How severe is the pain? The outcome will be evaluated using the Visual Analog Scale (VAS), which ranges from 0 to 10, with higher scores indicating a worse outcome.
Measured: 6th and 12th month
Periapical pathology
Standardized digital periapical radiographs will be taken using the long cone paralleling technique to assess periapical status, presence of radiolucent lesions, and periodontal ligament space. Radiographs will be obtained at baseline, 6 months, and 12 months to monitor treatment outcomes and detect any pathological changes.
Measured: 6th and 12th month
Tenderness to percussion
- Usually, the back of a dental mirror handle or the handle of a periodontal probe is used.
- First, vertical percussion (lightly tapping the occlusal surface from above) is performed, followed by lateral percussion (lightly tapping the side of the tooth) if necessary.
- It is compared with other teeth in the same area. If the pain is only in one tooth, it suggests pathology.
- The patient describes the pain as "aching," "discomfort," or "severe pain." This severity indicates the severity of the inflamation
Measured: 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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 Mature Permanent 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zeliha gonca bek kurklu, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120009
- Sponsor's protocol ID
- cu dişhekimligi
- Status last verified
- Aug 2025
- First submitted
- 24 Jun 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chua SKX, Sim YF, Wang WC, Mok BYY, Yu VSH. One-year outcome of selective caries removal versus pulpotomy treatment of deep caries: A pilot randomized controlled trial. Int Endod J. 2023 Dec;56(12):1459-1474. doi: 10.1111/iej.13978. Epub 2023 Oct 5.
PubMed 37795835
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Caries Removal Versus Partial Pulpotomy in the Treatment of Deep Caries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07120009
- Acronym / sponsor ID
- cu dişhekimligi
- Keywords
- Vital pulp therapy, Deep caries, Selective caries removal, Partial pulpotomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Aug 2025 (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 study was to compare the one-year results of selective caries removal and partial pulpotomy treatments in terms of pulp survival and the need for further endodontic treatment in deep carious lesions.Individuals aged 18-65 years with medically healthy mature permanent teeth with deep caries will be included. The included teeth will be randomly assigned to the selective caries removal or partial pulpotomy group. Follow-up evaluations will be performed at 6 months and 12 months. The main outcome is pulp survival as determined by clinical and radiographic success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| selective caries removal | Experimental | Procedure: selective caries removalDeep caries lesions will be treated with selective caries removal and followed up |
| partial pulpotomy | Experimental | Procedure: partial pulpotpmyDeep caries lesions will be treated with partial pulpotomy and followed up |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals aged 18-65
- ASA I or II general health status
- Deep primary or secondary caries lesion (up to 75% dentin thickness)
- Restorable permanent teeth with mature apex
- Teeth without clinical and radiographic periapical pathology
Key exclusion criteria (5 listed)
- Pregnancy
- Periapical lesion
- Spontaneous pain or tenderness to palpation
- Teeth for which pulp opening or crown/root supported prosthesis is planned
- Localized severe periodontitis
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 |
|---|---|---|
| selective caries removalThe caries is not completely removed but covered with a remineralizing material. Its purpose is to maintain pulp vitality. | Procedure or surgery | selective caries removal |
| partial pulpotpmyComplete cleaning of the caries resulting in pulp expose. pulp tissue is surgically removed by 1-3 mm.The aim is to remove the inflamed superficial pulp tissue to allow healing from the underlying healthy tissue. | Procedure or surgery | partial pulpotomy |
Primary outcome
Assessment of pain
Time frame: 6th and 12th month
Detailed medical history * Is the pain constant or intermittent? * How severe is the pain? The outcome will be evaluated using the Visual Analog Scale (VAS), which ranges from 0 to 10, with higher scores indicating a worse outcome.
Periapical pathology
Time frame: 6th and 12th month
Standardized digital periapical radiographs will be taken using the long cone paralleling technique to assess periapical status, presence of radiolucent lesions, and periodontal ligament space. Radiographs will be obtained at baseline, 6 months, and 12 months to monitor treatment outcomes and detect any pathological changes.
Tenderness to percussion
Time frame: 12th month
1. Usually, the back of a dental mirror handle or the handle of a periodontal probe is used. 2. First, vertical percussion (lightly tapping the occlusal surface from above) is performed, followed by lateral percussion (lightly tapping the side of the tooth) if necessary. 3. It is compared with other teeth in the same area. If the pain is only in one tooth, it suggests pathology. 4. The patient describes the pain as "aching," "discomfort," or "severe pain." This severity indicates the severity of the inflamation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Results publication: PubMed 37795835Chua SKX, Sim YF, Wang WC, Mok BYY, Yu VSH. One-year outcome of selective caries removal versus pulpotomy treatment of deep caries: A pilot randomized controlled trial. Int Endod J. 2023 Dec;56(12):1459-1474. doi: 10.1111/iej.13978. Epub 2023 Oct 5.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing selective caries removal and partial pulpotpmy in people with Deep Dentin Caries in Mature Permanent Teeth, run by Cukurova University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zeliha g bek kurklu (+905334500892, goncabek@mynet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain (time frame: 6th and 12th month). The study lists 3 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 NCT07120009, 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 13 Aug 2025.