Locally Delivered Antibiotics for the Treatment of Periodontitis Topical Doxycycline Versus Minocycline Gels as an Adjunct to Mechanical Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 主要终点
- plaque index
研究概览
简要总结
The sample consists of patients with moderate to severe periodontitis who will be subjected to machanical therapy in combination to local antibiotics. The participants will be divided into two groups, mechanical therapy with metronidazole hyclate, and mechanical therapy with minocycline hydrochloride. Both antibiotics will be delivered locally as gels. Outcome measures include probing pocket depth and several gingival indices. IL6 will be also measured for all participants.
详细描述
Forty-four patients in the age group of 25-50 years (males and females) who are suffering from periodontitis with almost similar probing depth bilaterally (≥ 6 mm) at the selected sites and exhibiting bleeding on probing.
A written informed consent will be taken from the patients prior to the study.
Each patient will be recalled 4 weeks after completion of both sides supra-gingival scaling, which formed the baseline visit. Plaque scores will be brought to zero, and the probing pocket depth and gingival index, will be recorded on the proforma specially prepared for the purpose.
The selected treatment sites will be then divided into two groups, and sub-gingival SRP will be performed prior to the delivery of the drugs at the test sites.
- Group I: Consist of periodontal pockets on the left side of maxillary or mandibular arch and received sub-gingival Minocycline 2% gel.
- Group II: Consist of periodontal pockets on the left side of maxillary or mandibular arch and received Metronidazole 0.75% gel.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients suffering from chronic periodontitis with almost similar probing depth bilaterally (≥
- •6 mm) at the selected sites and exhibiting bleeding on probing Patients with no caries and restorations on the selected teeth
- •Patients showing effective individual oral hygiene.
排除标准
- •Patients presenting with history of intake of local and/or systemic antibiotic therapy for the last 3 months
- •Patients with known systemic and debilitating diseases (Muscular Dystrophy)
- •Patients presenting with known adverse reactions to any component of the test agent
- •Patients on anticoagulant therapy
- •Pregnant and lactating females
- •Patients in a regular use of mouth wash
研究组 & 干预措施
Mincycline hydrochloride 2% oral gel
Minocycline will be delivered locally in the periodontal pocket.
干预措施: Minocycline Topical (Drug)
Metronidazole hylcate 0.75 % oral gel
Metronidazole gel will be delivered locally in the periodontal pocket.
干预措施: Metronidazole Topical Gel (Drug)
结局指标
主要结局
plaque index
时间窗: Baseline to six weeks
To measure the state of oral hygiene as: 0 = No plaque in the gingival area 1. = A film of plaque adhering to the free gingival margin and adjacent of the tooth 2. = Moderate accumulation of soft deposits within the gingival pocket 3. = Abundance of soft matter within the gingival pocket The Plaque Index is the four gingival areas of the tooth (buccal, lingual/palatal, mesial, distal) given a score from 0-3 and scores were added and divided by four. The plaque index for the individual was obtained by adding the indices for the teeth and divide by the number of teeth examined.
gingival index
时间窗: Baseline to six weeks
To assess the gingival condition and record qualitative chances in the gingiva as: 0 = Normal gingiva 1. = Mild inflammation - slight change in color and slight edema but no bleeding on probing. 2. = Moderate inflammation - redness, edema and glazing, bleeding on probing 3. = Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding. The bleeding will be assessed by gently probing along the wall of the soft tissue of the gingival sulcus. To get the gingival index for the tooth, the four areas of the tooth (buccal, lingual/palatal, mesial, distal) are scored by the sum and divided by four. The gingival index for the individual will be obtained by adding the indices of the teeth and divided by the number of teeth examined.
probing depth
时间窗: Baseline to six weeks
The distance from the gingival margin to base of the sulcus. Will be measured at six sites per tooth (mesio-buccal, buccal, disto-buccal, disto-lingual, lingual and mesio-lingual) at all teeth with UNC-15 probe.
IL6
时间窗: Baseline to six weeks
In healthy subjects it ranges from 0.5-5 pg/ml In eosinophilic subjects it ranges from 3-18pg/ml in plasma
次要结局
未报告次要终点
研究者
Sasha Suliman
lecturer
Riyadh Elm University