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 | Recruiting

• 1 other identifier: 2025/6/5/4
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

periodontitis; statins; lovastatin; smoking; periodontal disease

Outcome Measures

Primary Outcomes (4)

• Clinical Attachment Level

  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

  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)

  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)

  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 Outcomes (1)

• Infrabony Defect Depth

  from baseline to six months after intervention

Study Arms (4)

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

EXPERIMENTAL

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

Generally healthy patients active smokers with periodontits

EXPERIMENTAL

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

Generally healthy patients, active smokers with periodontits

PLACEBO COMPARATOR

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

patients generally healthy, non-smokers, diagnosed with periodontitis

PLACEBO COMPARATOR

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

Interventions

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.

Generally healthy patients active smokers with periodontits; patients generally healthy, non-smokers, diagnosed with periodontal disease

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.

Generally healthy patients, active smokers with periodontits; patients generally healthy, non-smokers, diagnosed with periodontitis

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Statin allergy
• receiving systemic statin therapy,
• alcoholics
• immunocompromised patients
• pregnant or breastfeeding women.

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

Pietrzko Dental Clinic

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

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Smoking

Interventions

Lovastatin

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Magdalena Pietrzko, DMD

CONTACT

+48604796143; pietrzkoperio@gmail.com

Rafał Wiench, profesor

CONTACT

rwiench@sum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After the SRP procedure is applied within the qualified gingival pockets, a gel drug (1.2% concentration of lovastatin) will be applied to the first designated site, and a placebo gel (split-mouth design) will be applied to the second site.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 15, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2025-11

Locations

PL (1)