An interventional study of Subgingival application of 1.2% lovastatin and Subgingival application of placebo gel in Periodontal Diseases, Periodontitis and Periodontal Disease, sponsored by Medical University of Silesia. Recruiting at 1 site in Poland. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Medical University of Silesia · Not applicable, Interventional, and Treatment
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:
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:
Exclusion Criteria:
Test side- gingival pocket that meets the inclusion criteria and to which a gel containing 1.2% lovastatin will be assigned in patients generally healthy, non-smokers, diagnosed with periodontitis.
Drug: Subgingival application of 1.2% lovastatin
Test side- gingival pocket that meets the inclusion criteria and to which a gel containing 1.2% lovastatin will be assigned in patients generally healthy,smokers, diagnosed with periodontitis.
Drug: Subgingival application of 1.2% lovastatin
control side: gingival pocket that meets the inclusion criteria and to which a placebo gel in patients generally healthy, smokers, diagnosed with periodontitis.
Drug: Subgingival application of placebo gel
control side: gingival pocket that meets the inclusion criteria and to which a placebo gel in patients generally healthy, non-smokers, diagnosed with periodontitis.
Drug: Subgingival application of placebo gel
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.
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.
Clinical Attachment Level
the distance between the enamel-cement junction (CEJ) and the bottom of the gingival pocket; expressed in mm
Time frame: change from baseline to 6 months after intervention
Probing Depth
the distance between the gingival margin and the bottom of the gingival pocket, measured with a calibrated periodontalprobe, expressed in mm
Time frame: change from baseline to 6 months after intervention
modified Sulcus Bleeding Index (mSBI)
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.
Time frame: from baseline to six months after intervention
Plaque Index Pl.I. (Silness i Löe)
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.
Time frame: from baseline to 6 months after intervention
Infrabony Defect Depth
a parameter measured as the distance from the edge of the alveolar crest to the bottom of the bony defect; assessed on conebeam computed tomography (CBCT) scanning
Time frame: from baseline to six months after intervention
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Medical University of Silesia