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.

Condition(s) studied

Investigational drug(s) / intervention(s)

Subgingival application of 1.2% lovastatin: Each patient will be assigned 2 sites that meet the inclusion criteria. After the SRP (scaling, root planing) procedure is applied within the qualified gingival pockets, a gel drug (1.2% concentration of lovastatin) will be applied to one site selected by randomization.

Subgingival application of placebo gel: Each patient will be assigned 2 sites that meet inclusion criteria. After the SRP procedure (scaling, root planing) procedure is applied within qualified gingival pockets, placebo gel will be applied to one site selected by randomization.

Study 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

Primary outcome measure(s)

• Clinical Attachment Level — change from baseline to 6 months after intervention
  the distance between the enamel-cement junction (CEJ) and the bottom of the gingival pocket; expressed in mm
• Probing Depth — change from baseline to 6 months after intervention
  the distance between the gingival margin and the bottom of the gingival pocket, measured with a calibrated periodontalprobe, expressed in mm
• modified Sulcus Bleeding Index (mSBI) — from baseline to six months after intervention
  an index used to determine the severity of inflammation in the periodontal tissues; determines the percentage of the study area that is inflamed. Expressed as a percentage, where 0% indicates no inflammation and 100% indicates maximum inflammation.
• Plaque Index Pl.I. (Silness i Löe) — from baseline to 6 months after intervention
  an index that evaluates the patient's level of oral hygiene on a numerical scale of 0-3. Optimal hygiene occurs at values \<1, while values \>1 indicate insufficient hygiene that needs improvement. The higher the value, the worse the hygiene.

Trial sites (1)

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