NCT07282756 Evaluation Of The Efficacy Of Subgingival Application Of Lovastatin Gel As An Adjunct To Non-Surgical Treatment Of Periodontitis In Generally Healthy Smokers And Non-Smokers Patients in Central Europe.
| NCT ID | NCT07282756 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Silesia |
| Condition | Periodontal Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2025-07-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the study is to evaluate how a gel (1.2% lovastatin) applied under the gum improves the results of classic periodontal treatment (SRP-scaling, root planing). The study involves two groups of adults diagnosed with periodontitis: the first group consists of generally healthy individuals who do not smoke tobacco. The second group consists of generally healthy individuals who have been smoking for at least 5 years. Before the study begins, each participant will undergo gum health measurements. Changes in these parameters will be monitored throughout the study. Two teeth will be selected for each participant: * a gel containing the medication will be applied under the gum of one tooth * a gel that looks similar to the medication but does not contain any medicinal substance will be applied under the gum of the second tooth. Before applying the gel, each participant will undergo subgingival cleaning (SRP) to remove any debris that may prevent the medicine from working. The study will last six months. Expected results: * all participants will experience an improvement in the condition of their gums after treatment * the effect of treatment will be better in non-smokers than in smokers * the treatment outcome will be better in the area where the medicated gel was applied compared to areas where the gel without medicinal substances was applied.
Eligibility Criteria
Inclusion Criteria: * generally healthy patients * diagnosed periodontal disease (at least one pair of non-adjacent sites with PD≥5 mm or CAL ≥4 mm and vertical bone loss ≥ 3 mm) * no history of periodontal disease treatment * no history of antibiotic use in the past 6 months * an eligible tooth must be alive, with no history of endodontic treatment * non-smoking (group I) or active smokers (group 2) Exclusion Criteria: * Statin allergy * receiving systemic statin therapy, * alcoholics * immunocompromised patients * pregnant or breastfeeding women.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07282756 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 59 Years, studying Periodontal Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07282756 currently recruiting?
Yes, NCT07282756 is actively recruiting participants. Contact the research team at pietrzkoperio@gmail.com for enrollment information.
Where is the NCT07282756 trial being conducted?
This trial is being conducted at Bielsko-Biala, Poland.
Who is sponsoring the NCT07282756 clinical trial?
NCT07282756 is sponsored by Medical University of Silesia. The trial plans to enroll 44 participants.