Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07282756

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.

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pietrzko Dental Clinic

Bielsko-Biala, Silesian Voivodeship, 43-300, Poland

Location status: Recruiting

Location contact

Magdalena Pietrzko, DMD

CONTACT

[email protected]

+48604796143

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subgingival application of 1.2% lovastatin

Drug

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

Drug

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.

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Magdalena Pietrzko, DMD

CONTACT

[email protected]

+48604796143

Rafał Wiench, profesor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

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.

Acronym: RCT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.