Lovastatin gel under the gum plus deep cleaning for periodontitis in smokers and non-smokers
Assessment of Changes in Clinical and Radiological Parameters in Gingival Pockets After Subgingival Application of Lovastatin Gel in Combination With SRP Procedure Compared to SRP and Placebo Gel Application in the Treatment of Periodontal Disease in Generally Healthy Non-smokers and Smokers From Central Europe: a Split-mouth Randomized Controlled Trial.
This test sees if placing a 1.2% lovastatin gel under the gum after deep cleaning helps adults with periodontitis, comparing smokers and non-smokers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Medical University of Silesia Academic / other |
| Locations | 1 site (Bielsko-Biala, Silesian Voivodeship) |
| Trial ID | NCT07282756 on ClinicalTrials.gov |
What this trial studies
Adults with periodontitis receive standard subgingival cleaning (scaling and root planing) and two matched teeth are chosen per person for a split-mouth comparison: one site receives 1.2% lovastatin gel and the other receives a placebo gel. The study enrolls two groups of generally healthy participants: long-term smokers (≥5 years) and non-smokers. Periodontal measurements (pocket depth, clinical attachment level, and other gum health parameters) are recorded before treatment and monitored over follow-up visits to compare healing at medicated versus placebo sites. The design isolates the local effect of lovastatin when used as an adjunct to conventional non-surgical therapy.
Who should consider this trial
Good fit: Generally healthy adults with untreated periodontitis who are either non-smokers or active smokers of at least five years and who are not taking systemic statins would be the ideal candidates.
Not a fit: People with statin allergy, current systemic statin therapy, immunocompromise, pregnancy or breastfeeding, heavy alcohol use, or teeth with prior endodontic treatment are unlikely to be eligible or to benefit from this local intervention.
Why it matters
Potential benefit: If successful, adding local lovastatin could improve gum healing and reduce pocket depths beyond what deep cleaning alone achieves.
How similar studies have performed: Previous small studies using locally delivered statins in periodontal pockets have reported modest improvements in pocket depth and attachment, so this approach has some preliminary positive evidence but is not yet definitive.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bielsko-Biala, Silesian Voivodeship
- Pietrzko Dental Clinic — Bielsko-Biala, Silesian Voivodeship, Poland (Recruiting)
Study contacts
- Study coordinator: Magdalena Pietrzko, DMD
- Email: pietrzkoperio@gmail.com
- Phone: +48604796143
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.