MedTrace Logo

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.

NCT07282756 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-02-20

No results posted yet for this 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.

Conditions

  • Periodontal Diseases
  • Periodontitis
  • Periodontal Disease
  • Smokers

Interventions

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.

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.

Sponsors & Collaborators

  • Medical University of Silesia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-11
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07282756 on ClinicalTrials.gov