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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorMedical University of Silesia

About this trial

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

Qualifiers

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

Disqualifiers

Statin allergy

receiving systemic statin therapy,

alcoholics

immunocompromised patients

Trial design

Treatments tested in this trial

  • Subgingival application of 1.2% lovastatin
  • Subgingival application of placebo gel

Treatment groups

44 Participants
are divided into 4 treatment groups

Sponsors and collaborators