Actively Recruiting
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.
Led by Medical University of Silesia · Updated on 2026-02-20
44
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Generally healthy adults aged 18 to 59 years
- Diagnosed periodontal disease with at least one pair of non-adjacent sites with probing depth 65 mm or clinical attachment level 64 mm and vertical bone loss 63 mm
- No prior treatment for periodontal disease
- No antibiotic use in the past 6 months
- Eligible teeth must be alive with no history of root canal treatment
- Participants must be either non-smokers or active smokers for at least 5 years
You will not qualify if you...
- Allergy to statins
- Currently receiving systemic statin therapy
- History of alcoholism
- Immunocompromised status
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 1 location
1
Pietrzko Dental Clinic
Bielsko-Biala, Silesian Voivodeship, Poland, 43-300
Actively Recruiting
Research Team
M
Magdalena Pietrzko, DMD
CONTACT
R
Rafał Wiench, profesor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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