The Effect of Genetic Polymorphisms on the Success of Vital Pulp Therapy

NCT07130214 | Active Not Recruiting FDA Drug

• 2 other identifiers: B.30.2.ATA.0.01.00/24248446
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulp Exposure, Dental; Pulp Disease, Dental; Pulp Caping; Pulpitis; Pulpitis - Irreversible; Pulpal Inflammation

Keywords

Biodentine; Pulp Capping; SNP

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end DNA analysis at 18 months

Study Arms (1)

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.

Drug: Biodentine

Interventions

Biodentine DRUG

Biodentine is used in the treatment of existing dentin damage thanks to active bio-silicate technology.

Also known as: MTA, Pulp Capping Material

Patient indicated with pulp capping

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ataturk University Faculty of Dentistry Endodontics Department

You may qualify if:

• 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,
• 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)

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Ataturk University: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Dental Pulp Exposure; Dental Pulp Diseases; Pulpitis

Interventions

tricalcium silicate; Pemetrexed; Healthco pulp capping material

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: May 2, 2025
• Primary Completion: May 2, 2026
• Study Completion (Estimated): November 2, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

TU (1)