Scaling and Root Planning With Localized Delivery of Autogenous Growth Factors- Platelet Rich Fibrin (PRF): A Randomized Split-mouth Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in clinical attachment level (CAL)
研究概览
简要总结
The purpose of this research study is to find out about the effect of growth factors extracted from blood on improving healing of periodontal pockets (Gum pockets) after deep gum cleaning.
详细描述
Blood has a lot of cells that help with healing and regeneration. These cells could be obtained by spinning blood in a centrifuge machine which allows the cells to separate at high spinning forces. After spinning, the blood will be separated into 3 different layers. The middle layer has the highest concentration of cells that help in healing and it is called the leukocyte platelet rich plasma (L-PRF).
The aim of this study is to use participant's own blood to retrieve (L-PRF) and place it in the diseased tissue around teeth, after the deep cleaning, to examine its effect in improving the healing and compare the results with gum pockets that haven't received L-PRF
In this study, participants will be asked to do the following things:
- Visit VCU Graduate Periodontics clinic 6 times for scheduled study visits after the initial periodontal exam.:
- 1st appointment: A digital impression of upper and lower teeth using an intraoral scanner, a light source laser that will capture digital impressions of the teeth, will be taken. These digital impressions will be used to create removable resin stents that fit on top of the teeth which will help in obtaining accurate and reproducible clinical measurements. The stents will be used on almost all participant's visits to the graduate periodontics clinic for the duration of the study for data collection.
- 2nd and 3rd appointment: The deep cleaning will be divided into 2 appointments which should be less than 2 weeks apart. During each appointment, one arch, either the upper or the lower arch, will be scaled and root planed. Local anesthesia will be used to anesthetize the participant before the cleaning. Ultrasonic cleaner and hand instruments will be used for the deep cleaning. After finishing the deep cleaning, 36 ml of participant's blood will be collected in 4 tubes through the antecubital vein. The tubes will be spun in an FDA approved spinning machine to obtain the liquid and membrane forms of the L-PRF. The L-PRF will then be inserted in the test sites on one side of the arch while the other side will not receive the L-PRF.
- 4th appointment: Prophylaxis and plaque control 2 weeks after 2nd appointment.
- 5th appointment: Evaluation of deep periodontal cleaning and data collection 4-5 weeks after the 2nd appointment
- 6th appointment: Periodontal cleaning and data collection 3 months after 2nd appointment.
- Follow the oral hygiene instructions given
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy (ASA 1 or 2) adults over the age of 18
- •A similar number of bilateral 5-8 mm pocket depths
- •Diagnosed with Stage II or Stage III chronic periodontitis.
排除标准
- •Uncontrolled systemic illness that may affect healing or clotting such as diabetes mellitus, immunocompromisation, bleeding disorders, ongoing chemo- or radiotherapy
- •Active smokers
- •Pregnancy
- •Periodontal treatment in the last six months
- •Antibiotic therapy within three months prior to treatment
- •Taking medications that could affect periodontal status or healing
结局指标
主要结局
Change in clinical attachment level (CAL)
时间窗: Baseline to 6 months
CAL will be measured from cemento-enamel junction CEJ to the base of the pocket using the same stent as PD
Gingival index
时间窗: Baseline to 6 months
GI will be recorded using the Loe and Silness gingival index. Scores range from 0 - Normal gingiva to 3 - Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding.
Change in probing depths (PD)
时间窗: Baseline to 6 months
PD will be measured from the gingival margin to pocket base using a participant specific fabricated removable resin stent with an assigned #15 UNC probe.
Bleeding on probing (BOP)
时间窗: Baseline to 6 months
Bleeding on probing (BOP) will be recorded on an ordinal scale where sites that will bleed on probing will be given a score of 1 while sites that don't bleed will be given a score of 0.
Plaque index (PI)
时间窗: Baseline to 6 months
PI will be recorded using the Loe and Silness Index. Scores range from 0 - No plaque to 3 - Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
次要结局
未报告次要终点