Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT07282756
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EVALUATION OF THE EFFECTIVNESS OF SUBGINGIVAL APPLICATION OF 1.2% LOVASTATIN GEL AS AN ADJUNCT TO NON-SURGICAL TREATMENT OF PERIODONTITIS IN GENERALLY HEALTHY SMOKERS AND NON-SMOKERS PATIENTS FROM CENTAL EUROPE- A SPLIT-MOUTH RANDOMIZED CONTROLLED TRIAL.
Sponsor:
Medical University of Silesia
Organization:
Study Overview
Official Title:
Assessment of Changes in Clinical and Radiological Parameters in Gingival Pockets After Subgingival Application of 1.2% 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.
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RCT
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: