"Efficacy of Noisome as A Carrier of Locally Delivered Minocycline Hydrochloride Gel in Stage II or Stage III Periodontitis: A Randomized Controlled Clinical Trial With Biochemical Analysis"
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To measure clinical assessment Plaque Index (PI) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of Noisome as carrier of minocycline hydrochloride gel to minocycline hydrochloride in Stage II or Stage III Periodontitis . The main questions it aims to answer are:
- Is the Noisome carrier of minocycline hydrochloride has an effect in comparing to minocycline hydrochloride in Stage II or Stage III Periodontitis?
- what is the release profile of of minocycline hydrochloride noisome gel and minocycline hydrochloride gel? Participants will be asked to maintain oral hygiene after application of treatment Researchers will compare the effect of noisome as a carrier of locally delivered minocycline hydrochloride gel to minocycline hydrochloride gel in stage II or stage III periodontitis patients as an adjunct to non-surgical periodontal treatment] to see if Plaque Index (PI) , Gingival index,Clinical attachment level (CAL) &Periodontal Pocket Depth decreased or not.
详细描述
This study is designed to be a Randomized, Controlled, blinded, clinical trial; the eligible participants will be randomly allocated for one of the two comparative parallel-Groups; test and control group . The interventions will be prepared by the pharmacist and coded and the whole-time frame for the study will be 18 weeks.
The intervention to all participants will be Non-surgical debridement the the test group will receive the Noisome minocycline hydrochloride & control group will receive minocycline hydrochloride.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study.
- •Generalized Periodontitis (Stage II or stage III ) Patients; ( ≥ 3 mm CAL, PD 5-7 mm ) , premolar-molar area (test site) .
- •Having more than 16 tooth excluding wisdom and test teeth that still had both mesial and distal neighboring teeth.
- •Systemically free according to the modified Burkitt's health history questionnaire
排除标准
- •Non-surgical periodontal therapy within the previous 12 months, systemic or local use of antibiotics with the previous 3 months, medication with possible influence on the periodontium.
- •Pregnancy or contraceptives usage.
- •Breastfeeding.
- •Known allergy to the ingredients of the treatment.
- •vulnerable group; prisoners & orphans .
研究组 & 干预措施
Minocycline hydrochloride with noisome as carrier
Group I ( Minocycline hydrochloride with noisome carrier)
15 patients will receive the drug ( Minocycline hydrochloride with noisome carrier gel) at intervals 1,3,7&14 days
干预措施: Minocycline hydrochloride with noisome carrier (Drug)
Minocycline hydrochoride only
Group II (Minocycline hydrochloride only)
15 patients will receive the drug (Minocycline hydrochloride only gel) at intervals 1,3,7&14 days
干预措施: Minocycline Hydrochloride only (Drug)
结局指标
主要结局
To measure clinical assessment Plaque Index (PI) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)
时间窗: measured at the baseline, before the application of drug& after 18 weeks
To measure the clinical parameter Plaque Index (PI) on score from zero to three 0 = No plaque in gingival area. 1. = A film of plaque adhering to the free gingival margin and adjacent area of tooth. The plaque may be recognized only by running a probe across the tooth surface. 2. = Moderate accumulation of soft deposit within the gingival pocket and on the gingival pocket and on the gingival margin and/or adjacent tooth surface that can be seen by naked eye. 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
To measure clinical assessment Gingival Index (GI) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)
时间窗: measured at the baseline, before the application of drug& after 18 weeks
To measure the clinical parameter gingival Index(GI) on score from zero to three Gingival index (GI) 0 = Normal gingiva. 1. = Mild inflammation, slight change in color, slight edema; no bleeding on probing. 2. = Moderate inflammation, redness, edema, and glazing; bleeding on probing. 3. = Sever inflammation, marked redness and edema, ulceration; tendency to spontaneous bleeding.
To measure Clinical attachment level (CAL) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)
时间窗: measured at the baseline, before the application of drug& after 18 weeks
To measure Clinical attachment level (CAL) in millimeter (mm).
To measure Periodontal Pocket Depth (PPD) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)
时间窗: measured at the baseline, before the application of drug& after 18 weeks
To measure Periodontal Pocket Depth (PPD) in millimeter (mm).
次要结局
- - Evaluate the releasing profile of minocycline hydrochloride noisome gel and minocycline hydrochloride gel(first day then third day then seventh day lastly after fourteen days)
研究者
israa saiid
MSc student
Ain Shams University