Actively Recruiting

Phase Not Applicable
Age: 18Years - 59Years
All Genders
ID07282756

Assessment of Changes in Clinical and Radiological Parameters in Gingival Pockets After Subgingival Application of Lovastatin Gel Combined With Scaling and Root Planing in Healthy Smokers and Non-Smokers with Periodontal Disease

Led by Medical University of Silesia · Updated on 2026-02-20

44

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of a 1.2% lovastatin gel applied under the gum to improve outcomes of classic periodontal treatment called scaling and root planing (SRP). The study compares adults with periodontitis who are generally healthy, dividing them into two groups: non-smokers and smokers with at least 5 years of tobacco use. The goal is to assess whether the medicated gel improves gum health more than a placebo gel without medicine. Participants will receive two treatments on different teeth: one tooth will get the lovastatin gel under the gum after SRP cleaning, and another tooth will receive a similar-appearing placebo gel. The study lasts six months, observing differences between smokers and non-smokers and between treated and placebo areas. The treatment is applied directly to gum pockets meeting specific criteria. During the study, participants will have gum health measured by clinical attachment level, probing depth, bleeding index, and plaque index before treatment and up to six months after. Researchers will monitor changes in gum condition and bone defect depth. The study involves regular assessments to track treatment effects and safety over the full six-month period.

CONDITIONS

Brief 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

Age: 18Years - 59Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Generally healthy patients
  • Diagnosed periodontal disease with at least one pair of non-adjacent sites having probing depth ≥5 mm or clinical attachment level ≥4 mm and vertical bone loss ≥3 mm
  • No prior treatment for periodontal disease
  • No antibiotic use in the past 6 months
  • Eligible tooth must be alive with no history of root canal treatment
  • Non-smokers or active smokers
Not Eligible

You will not qualify if you...

  • Allergy to statins
  • Currently receiving systemic statin therapy
  • Alcoholism
  • Immunocompromised conditions
  • Pregnant or breastfeeding women

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment visit with follow-up assessments over 6 months

Participants receive scaling and root planing followed by subgingival application of either lovastatin gel or placebo gel to selected gingival pockets.

1 treatment visit and periodic follow-up visits for up to 6 months

Trial Site Locations

Total: 1 location

1

Pietrzko Dental Clinic

Bielsko-Biala, Silesian Voivodeship, Poland, 43-300

Actively Recruiting

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Research Team

M

Magdalena Pietrzko, DMD

R

Rafał Wiench, profesor

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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