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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- modified Sulcus Bleeding Index (mSBI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Statin allergy
- •receiving systemic statin therapy,
- •alcoholics
- •immunocompromised patients
- •pregnant or breastfeeding women.
研究组 & 干预措施
patients generally healthy, non-smokers, diagnosed with periodontal disease
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.
干预措施: Subgingival application of 1.2% lovastatin (Drug)
Generally healthy patients active smokers with periodontits
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.
干预措施: Subgingival application of 1.2% lovastatin (Drug)
Generally healthy patients, active smokers with periodontits
control side: gingival pocket that meets the inclusion criteria and to which a placebo gel in patients generally healthy, smokers, diagnosed with periodontitis.
干预措施: Subgingival application of placebo gel (Drug)
patients generally healthy, non-smokers, diagnosed with periodontitis
control side: gingival pocket that meets the inclusion criteria and to which a placebo gel in patients generally healthy, non-smokers, diagnosed with periodontitis.
干预措施: Subgingival application of placebo gel (Drug)
结局指标
主要结局
modified Sulcus Bleeding Index (mSBI)
时间窗: 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)
时间窗: 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.
Clinical Attachment Level
时间窗: 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
时间窗: 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
次要结局
- Infrabony Defect Depth(from baseline to six months after intervention)