Periodontal Disease, Periodontal Diseases, Periodontitis, Smokers
Conditions
Keywords
periodontitis, statins, lovastatin, smoking, periodontal disease
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.
Interventions
DRUGSubgingival 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.
DRUGSubgingival 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
Medical University of Silesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Level | 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 |
| Probing Depth | 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 |
| modified Sulcus Bleeding Index (mSBI) | 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. |
| Plaque Index Pl.I. (Silness i Löe) | 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
| Measure | Time frame | Description |
|---|---|---|
| Infrabony Defect Depth | 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 |
Countries
Poland
Contacts
CONTACTMagdalena Pietrzko, DMD
CONTACTRafał Wiench, profesor
Outcome results
None listed