Ireland
--:--IST
Active, not recruiting Observational

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

NCT07130214 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-05-02
Last updated
2025-11-18

Condition(s) studied

Pulp Exposure, DentalPulp Disease, DentalPulp CapingPulpitisPulpitis - IrreversiblePulpal Inflammation

Investigational drug(s) / intervention(s)

Biodentine →

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

Study 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.

Eligibility

Sex
ALL
Min age
16 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria * 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) Exclusion Criteria: * 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.

Primary outcome measure(s)

  • DNA Analysis — 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.

Trial sites (1)

FacilityCityRegionStatus
Ataturk University Erzurum Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07130214 on ClinicalTrials.gov ↗ ← All trials in Turkey