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. (RCT)

February 18, 2026 updated by: Medical University of Silesia

Assessment of Changes in Clinical and Radiological Parameters in Gingival Pockets After Subgingival Application of Lovastatin Gel in Combination With SRP Procedure Compared to SRP and Placebo Gel Application in the Treatment of Periodontal Disease in Generally Healthy Non-smokers and Smokers From Central Europe: a Split-mouth Randomized Controlled 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Silesian Voivodeship
      • Bielsko-Biala, Silesian Voivodeship, Poland, 43-300
        • Recruiting
        • Pietrzko Dental Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients generally healthy, non-smokers, diagnosed with periodontal disease
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
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.
Experimental: Generally healthy patients active smokers with periodontits
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
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.
Placebo Comparator: Generally healthy patients, active smokers with periodontits
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
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.
Placebo Comparator: patients generally healthy, non-smokers, diagnosed with periodontitis
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Attachment Level
Time Frame: 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
change from baseline to 6 months after intervention
Probing Depth
Time Frame: 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
change from baseline to 6 months after intervention
modified Sulcus Bleeding Index (mSBI)
Time Frame: 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.
from baseline to six months after intervention
Plaque Index Pl.I. (Silness i Löe)
Time Frame: 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.
from baseline to 6 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infrabony Defect Depth
Time Frame: from baseline to six months after intervention
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
from baseline to six months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/6/5/4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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