Efficiency of Hyaluronic Acid Versus Red Injectable Platelet-Rich Fibrin (i-PRF) in Treatment of Stage III Periodontitis (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Clinical Attachment Level
研究概览
简要总结
the aim of this clinical trial is to compare the efficacy of hyaluronic acid (HA) used as an adjunctive to scaling and root planing (SRP) and red injectable platelet rich-fibrin (i-PRF) in the non-surgical treatment of stage III periodontitis. The main question it aims to answer is: is there a difference between HA and red i-prf when used as an adjunct to SRP in terms of efficacy?
Participants who are eligible will be assigned to one of the treatment groups:
- Group 1= receives HA+ SRP
- Group 2= receives red i-prf + SRP
- Group 3= receives only SRP
Researchers will compare Groups 1,2 and 3 to see if there's a difference in the periodontal parameters measured.
详细描述
Complete medical and dental histories as well as informed consent will be collected from eligible participants, and periodontal charting will be done for them.
The selected patients will be allocated into three groups (each containing 25) with the help of a computerized randomizer (Randomizer.org):
- Group one (G1): 25 patients will be treated with hyaluronic acid gel as an adjunct to scaling and root planing by applying one ml of 0.8% HA to the base of the pocket (subgingivally) and 0.2 ml of 0.2% HA topically (applied by the patient).
- Group two (G2): 25 patients will be treated with red i-PRF as an adjunct to scaling and root planing.
- Group three (G3): 25 patients will be treated with scaling and root planing only.
The clinical examiner will not be informed of the treatment groups' distribution.
Before the baseline examination, a full mouth supragingival scaling and root planing will be performed under local anesthesia in one or two sessions (over a 24-hour period). Patients will be informed on self-performed plaque control measures, including using the modified Bass brushing technique using a soft toothbrush and regular toothpaste twice a day and interdental cleaning using interdental brushes once a day. Patients will receive the same toothbrushes, toothpaste, and interdental brushes.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical periodontal loss and radiographic bone loss of stage III/grades A and B with no history of systemic disease.
- •at least four periodontal sites with a pocket depth of six mm or greater
- •radiographic evidence of bone loss extending to the middle third of the root
- •clinical attachment loss of five mm or more
排除标准
- •uncontrolled systemic conditions (uncontrolled diabetes or uncontrolled hypertension)
- •bleeding disorders, or on anticoagulant therapy
- •alcohol users
- •pregnant or lactating females
- •heavy smokers (more than ten cigarettes per day)
- •chemo or radio therapy
- •antibiotic/anti-inflammatory drugs over the last three months before treatment.
研究组 & 干预措施
Treated with hyaluronic acid + SRP
After scaling and root planing, hyaluronic acid (GENGIGEL®) will be applied in the following forms (one ml of 0.8% HA was injected subgingivally once every four weeks), topically (0.2 ml of 0.8% HA applied by the patient twice daily for the following 14 days after the subgingival application).
干预措施: Hyaluronic acid (Drug)
Treated with red i-PRF + SRP
The red i-PRF will be injected into the pocket at the point of interdental space after SRP. Moreover, to control bleeding due to the needle tip after the procedure, a saline-soaked sponge will be placed between the lip and the gingiva and removed after 15 minutes. A total of four sessions of i-PRF will be administered to patients at a ten-day interval.
干预措施: red injectable platelet rich fibrin (i-prf) (Procedure)
结局指标
主要结局
Clinical Attachment Level
时间窗: 4 weeks
used to assess the loss of periodontal tissue support in periodontitis. It is the distance from the cemento-enamel junction (fixed point on the tooth) to the depth of the pocket
Probing Depth
时间窗: 4 weeks
used to detect the depth of the periodontal pocket. It is the distance from the gingival margin to the base of the pocket.
次要结局
- Gingival index(4 weeks)
- Bleeding on Probing(4 weeks)
- Plaque index(4 weeks)