EVALUATION OF THE EFFECTIVNESS OF SUBGINGIVAL APPLICATION OF 1.2% LOVASTATIN GEL AS AN ADJUNCT TO NON-SURGICAL TREATMENT OF PERIODONTITIS IN GENERALLY HEALTHY SMOKERS AND NON-SMOKERS PATIENTS FROM CENTAL EUROPE- A SPLIT-MOUTH RANDOMIZED CONTROLLED TRIAL. (RCT)

Medical University of Silesia

Status: Enrolling

Conditions: Periodontitis; Smokers; Periodontal Diseases; Periodontal Disease

Treatments: Drug: Subgingival application of 1.2% lovastatin; Drug: Subgingival application of placebo gel

Study type: Interventional

Funder types: Other

Identifiers

NCT07282756

2025/6/5/4

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 4 patient groups, including a placebo group

patients generally healthy, non-smokers, diagnosed with periodontal disease

Experimental group

Description:

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.

Treatment:

Drug: Subgingival application of 1.2% lovastatin

Generally healthy patients active smokers with periodontits

Experimental group

Description:

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.

Treatment:

Drug: Subgingival application of 1.2% lovastatin

Generally healthy patients, active smokers with periodontits

Placebo Comparator group

Description:

control side: gingival pocket that meets the inclusion criteria and to which a placebo gel in patients generally healthy, smokers, diagnosed with periodontitis.

Treatment:

Drug: Subgingival application of placebo gel

patients generally healthy, non-smokers, diagnosed with periodontitis

Placebo Comparator group

Description:

control side: gingival pocket that meets the inclusion criteria and to which a placebo gel in patients generally healthy, non-smokers, diagnosed with periodontitis.

Treatment:

Drug: Subgingival application of placebo gel