Pietrzko Dental Clinic
Bielsko-Biala, Silesian Voivodeship, 43-300, Poland
Location status: Recruiting
NCT Number: NCT07282756
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.
Interested in participating?
Request Info18 year–59 year
All sexes
Interventional
Not applicable
Bielsko-Biala, Silesian Voivodeship, 43-300, Poland
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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
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
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.
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.
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
Contact information is provided by the study sponsor or research team.
Magdalena Pietrzko, DMD
CONTACT
Rafał Wiench, profesor
CONTACT
Medical University of Silesia
Other
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
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.
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