Pulp Exposure, DentalNCT07130214
The Effect of Genetic Polymorphisms on the Success of Vital Pulp Therapy
An observational study of Pulp Exposure, Dental and Pulp Disease, Dental, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study employs saliva-based DNA analysis to investigate the effect of genetic polymorphisms, particularly SNPs in MMP, TIMP, TNF-α, and BMP genes, on the success of vital pulp therapy in permanent teeth with pulpitis, assessed through clinical follow-up. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Pulp Exposure, Dental, Pulp Disease, Dental, Pulp Caping
- What is being tested?
- Biodentine
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2025to 2 Nov 2026
- How long will I take part?
- 18 Months
- Phase
- Observational
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ataturk University Faculty of Dentistry Endodontics Department
Who may be able to join
- permanent teeth diagnosed with reversible pulpitis,
- patients diagnosed with irreversible pulpitis but without apical radiolucency, -teeth responding within normal limits to cold stimuli (using carbon dioxide snow),
- teeth with prolonged response to cold testing, diagnosed with irreversible pulpitis,
- teeth without sensitivity to percussion or chewing tests,
- teeth with bleeding time less than 5 minutes from exposed pulp tissue,
- teeth diagnosed with irreversible pulpitis with bleeding time less than 10 minutes,
Show all 9Show fewer
- teeth without widening of the periodontal ligament space (Periapical Index [PAI] ≥2),
- teeth with radiographically confirmed deep dentinal caries,
- patients classified as ASA I (American Society of Anesthesiologists Physical Status Classification)
Who cannot join
- teeth showing negative response to cold testing (using carbon dioxide snow), -teeth showing negative response to electric pulp testing,
- presence of apical radiolucency (PAI > 2),
- presence of condensing apical periodontitis in the relevant tooth,
- teeth with internal or external root resorption,
- teeth with a history of trauma,
- teeth with vertical root fractures,
Show all 13Show fewer
- evidence of periodontal-endodontic lesion on the day of treatment,
- loss of function (e.g., tooth mobility degree 3),
- presence of swelling related to the treated tooth,
- teeth that cannot be treated with rubber dam isolation,
- patients with compromised immune systems,
- patients who are pregnant at the time of treatment,
- patients who have used antibiotics, bisphosphonates, or statins within the last 4 weeks prior to treatment.
Trial locations and contacts
1 site in 1 country.
About this study
This study employs saliva-based DNA analysis to investigate the effect of genetic polymorphisms, particularly SNPs in MMP, TIMP, TNF-α, and BMP genes, on the success of vital pulp therapy in permanent teeth with pulpitis, assessed through clinical follow-up.
Read the detailed description
The treatment choice following pulp exposure due to dental caries in permanent mature teeth is still a topic of debate today.Vital pulp therapy is recommended in teeth with reversible or irreversible pulpitis which do not show periapical inflammation as it helps preserve the pulp's defense mechanism and facilitates new dentin formation.The success of vital pulp therapy depends on various factors such as age,the size of the exposed area,the amount of remaining tooth and response to vitality tests.It is known that the genetic makeup of patients can influence the success of vital pulp therapy.These genetic differences may arise from polymorphisms occurring in an individual's DNA sequence at a frequency of 1% or higher.Single nucleotide polymorphisms(SNPs)are considered the most common type of polymorphism and are thought to occur every 1000 base pairs in the human genome.Matrix metalloproteinases(MMPs),tissue inhibitors of metalloproteinases(TIMPs),tumor necrosis factor-α(TNF-α),bone morphogenic proteins(BMPs)which affect inflammation pathways and tissue remodeling,can also influence the success of this treatment.MMPs are associated with the degree of inflammation and the destruction of pulp tissues.They are crucial in the formation of the dentin matrix and secondary dentin and also immune response development.They are inhibited by TIMPs which are endogenously secreted. Polymorphisms in the MMP and TIMP genes increase the susceptibility of patients to pulp tissue destruction. MMP-9 facilitates tissue degradation in inflamed pulp tissue.TNF-α is a pro-inflammatory cytokine.The elevation of TNF-α levels in the pulp triggers inflammatory reactions by stimulating pulp cells to produce MMPs.BMPs promote the conversion of osteoprogenitor cells into osteoblasts.Specifically,BMP-4 factor initiates dentin formation.Therefore,it is likely that SNPs in the genes coding for these inflammatory mediators and growth factors can influence the success of vital pulp therapy.In the planned project,vital pulp therapy will be applied to teeth diagnosed with reversible or irreversible pulpitis,showing a positive response to vitality tests and no periapical radiolucency.Saliva samples will be collected from the included patients in Eppendorf tubes.After local anesthesia,the tooth will be isolated with a rubberdam and the decayed tissue will be removed until it reaches hard healthy dentin.The bleeding from the exposed pulp will be controlled for 30 seconds with a cotton pellet soaked in 2.5% NaOCl solution.After irrigation with sterile saline, the exposed area will be capped with a calcium silicate-based material called Biodentine(Septodont,France).The material will be sealed with resin-modified glass ionomer cement, and a permanent restoration will be placed.After the procedure,patients will be clinically and radiographically evaluated with a 12-month follow-up.DNA will be isolated from the saliva samples and the relationship between SNPs in the relevant genes and treatment success will be determined.
- Conditions
- Pulp Exposure, Dental, Pulp Disease, Dental, Pulp Caping, Pulpitis, Pulpitis - Irreversible, Pulpal Inflammation
- Being tested
- Biodentine
- Keywords
- Biodentine, Pulp Capping, SNP
- Medical subject headings
- Dental Pulp Exposure, Dental Pulp Diseases, Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineDrug
Also called MTA, Pulp Capping Material
Biodentine is used in the treatment of existing dentin damage thanks to active bio-silicate technology.
| Study group | Role | What they receive |
|---|---|---|
| Patient indicated with pulp capping | In the planned project,vital pulp therapy will be applied to teeth diagnosed with reversible or irreversible pulpitis,showing a positive response to vitality tests and no periapical radiolucency. Receives: Drug: Biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA Analysis
After treatment, patients will undergo clinical and radiographic evaluations at the 6th and 12th months. Treatments will be considered successful if the patient reports no complaints during follow-up; if clinical examination reveals no hypersensitivity to thermal stimuli, gingival swelling, sinus tract, mobility, or sensitivity to lateral and vertical percussion; and if radiographic examination shows no periradicular changes, root resorption, irregular calcification within the canal, and evidence of a radiopaque dentin bridge formation.After the 12-month follow-up period, the data obtained will be categorized according to patients' genetic profiles (i.e., polymorphism types), and the relationship between vital pulp therapy success and genetic polymorphism will be evaluated.
Measured: From enrollment to the end DNA analysis at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start2 May 2025
- Primary completion2 May 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Exposure, DentalStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Principal investigator, ertuğrul karataş, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130214
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/242
- Other IDs
- 48446
- Status last verified
- Nov 2025
- First submitted
- 12 Aug 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Genetic Polymorphisms on the Success of Vital Pulp Therapy
- ClinicalTrials.gov ID
- NCT07130214
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/242
- Conditions
- Pulp Exposure, Dental, Pulp Disease, Dental, Pulp Caping, Pulpitis, Pulpitis - Irreversible, Pulpal Inflammation
- Keywords
- Biodentine, Pulp Capping, SNP
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 2 May 2025 (actual)
- Primary completion
- 2 May 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 19 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.
This study employs saliva-based DNA analysis to investigate the effect of genetic polymorphisms, particularly SNPs in MMP, TIMP, TNF-α, and BMP genes, on the success of vital pulp therapy in permanent teeth with pulpitis, assessed through clinical follow-up.
Detailed description
The treatment choice following pulp exposure due to dental caries in permanent mature teeth is still a topic of debate today.Vital pulp therapy is recommended in teeth with reversible or irreversible pulpitis which do not show periapical inflammation as it helps preserve the pulp's defense mechanism and facilitates new dentin formation.The success of vital pulp therapy depends on various factors such as age,the size of the exposed area,the amount of remaining tooth and response to vitality tests.It is known that the genetic makeup of patients can influence the success of vital pulp therapy.These genetic differences may arise from polymorphisms occurring in an individual's DNA sequence at a frequency of 1% or higher.Single nucleotide polymorphisms(SNPs)are considered the most common type of polymorphism and are thought to occur every 1000 base pairs in the human genome.Matrix metalloproteinases(MMPs),tissue inhibitors of metalloproteinases(TIMPs),tumor necrosis factor-α(TNF-α),bone morphogenic proteins(BMPs)which affect inflammation pathways and tissue remodeling,can also influence the success of this treatment.MMPs are associated with the degree of inflammation and the destruction of pulp tissues.They are crucial in the formation of the dentin matrix and secondary dentin and also immune response development.They are inhibited by TIMPs which are endogenously secreted. Polymorphisms in the MMP and TIMP genes increase the susceptibility of patients to pulp tissue destruction. MMP-9 facilitates tissue degradation in inflamed pulp tissue.TNF-α is a pro-inflammatory cytokine.The elevation of TNF-α levels in the pulp triggers inflammatory reactions by stimulating pulp cells to produce MMPs.BMPs promote the conversion of osteoprogenitor cells into osteoblasts.Specifically,BMP-4 factor initiates dentin formation.Therefore,it is likely that SNPs in the genes coding for these inflammatory mediators and growth factors can influence the success of vital pulp therapy.In the planned project,vital pulp therapy will be applied to teeth diagnosed with reversible or irreversible pulpitis,showing a positive response to vitality tests and no periapical radiolucency.Saliva samples will be collected from the included patients in Eppendorf tubes.After local anesthesia,the tooth will be isolated with a rubberdam and the decayed tissue will be removed until it reaches hard healthy dentin.The bleeding from the exposed pulp will be controlled for 30 seconds with a cotton pellet soaked in 2.5% NaOCl solution.After irrigation with sterile saline, the exposed area will be capped with a calcium silicate-based material called Biodentine(Septodont,France).The material will be sealed with resin-modified glass ionomer cement, and a permanent restoration will be placed.After the procedure,patients will be clinically and radiographically evaluated with a 12-month follow-up.DNA will be isolated from the saliva samples and the relationship between SNPs in the relevant genes and treatment success will be determined.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient indicated with pulp capping | – | Drug: BiodentineIn the planned project,vital pulp therapy will be applied to teeth diagnosed with reversible or irreversible pulpitis,showing a positive response to vitality tests and no periapical radiolucency. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ataturk University Faculty of Dentistry Endodontics Department
Key inclusion criteria (9 listed)
- permanent teeth diagnosed with reversible pulpitis,
- patients diagnosed with irreversible pulpitis but without apical radiolucency, -teeth responding within normal limits to cold stimuli (using carbon dioxide snow),
- teeth with prolonged response to cold testing, diagnosed with irreversible pulpitis,
- teeth without sensitivity to percussion or chewing tests,
- teeth with bleeding time less than 5 minutes from exposed pulp tissue,
Key exclusion criteria (13 listed)
- teeth showing negative response to cold testing (using carbon dioxide snow), -teeth showing negative response to electric pulp testing,
- presence of apical radiolucency (PAI > 2),
- presence of condensing apical periodontitis in the relevant tooth,
- teeth with internal or external root resorption,
- teeth with a history of trauma,
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 |
|---|---|---|
| BiodentineAlso: MTA, Pulp Capping MaterialBiodentine is used in the treatment of existing dentin damage thanks to active bio-silicate technology. | Drug | Patient indicated with pulp capping |
Primary outcome
DNA Analysis
Time frame: From enrollment to the end DNA analysis at 18 months
After treatment, patients will undergo clinical and radiographic evaluations at the 6th and 12th months. Treatments will be considered successful if the patient reports no complaints during follow-up; if clinical examination reveals no hypersensitivity to thermal stimuli, gingival swelling, sinus tract, mobility, or sensitivity to lateral and vertical percussion; and if radiographic examination shows no periradicular changes, root resorption, irregular calcification within the canal, and evidence of a radiopaque dentin bridge formation.After the 12-month follow-up period, the data obtained will be categorized according to patients' genetic profiles (i.e., polymorphism types), and the relationship between vital pulp therapy success and genetic polymorphism will be evaluated.
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 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
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?
An observational study of Pulp Exposure, Dental and Pulp Disease, Dental, run by Ataturk 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 9 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2025. 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?
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?
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?
DNA Analysis (time frame: From enrollment to the end DNA analysis at 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.