Liquid S-Platelet Rich Fibrin as a Potential Adjunct in Conservative Closed Periodontal Debridement for Periodontitis Stages II-IV: A Randomized, Split-mouth, 3-month Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Periodontal probing depth
研究概览
简要总结
What is the purpose of this study? This study is to investigate the effect of a processed blood product in healing after treatment for gum disease. In addition to scaling & root debridement (deep cleaning) that is the standard treatment for periodontitis, this study will test the effectiveness of patient's processed blood in improving healing of diseased gums.
What are the procedures to be followed? First, all patients will undergo dental check-up and X-ray imaging for suitability as a participant for the project. For participants who are eligible and included into study, upper & lower jaws models will be made, and each will be given oral care kit & instructions. The next appointment will be given for scaling & root debridement with local numbing agent in one day. Towards the end of the treatment, a small amount (20 mℓ) of blood will be collected and spun to produce liquid platelet-rich fibrin that is then used to flush the treated gum pockets in half of the mouth. For the treated gum pockets in the opposite half of the mouth, sterile salt water (saline) will be used instead for comparison. Then, follow-up appointments are at monthly intervals until 3 months.
Who should enter the study? Symptoms of gum disease include bleeding and/or receding gums, tooth/teeth appearing longer or feeling shaky/loose/weak, formation of large amount of calculus and/or black/empty space between teeth, frequent/recurrent gum swelling/pus, and/or bad breath.
详细描述
Introduction: We appreciate your participation in the present study. This study is to investigate the effect of a processed blood product in healing after treatment for severe gum disease.
What is the purpose of this study? This study will test the efficacy of a biomaterial made by processing blood drawn from the participant's own arm that may improve healing once inserted into diseased gum pockets. For comparison, the other material used will be saline, which together with scaling & root debridement forms the basic standard of care protocol for the treatment of periodontitis.
What are the procedures to be followed? Clinical examination will be done on all the participants to screen and check for the suitability to be included as a participant for the project. Panoramic X-ray radiograph(s) will be taken to see the bone height underneath the gums. Included participants will be given oral care instructions & kit, and have alginate molds taken of their upper & lower jaws for making a custom guide. The first appointment will be given for scaling & root debridement with local numbing agent in one day. Towards the end of the treatment, 20 mℓ of blood will be collected from a vein in either arm. The blood will be processed to produce a liquid material that will be irrigated into tested gum pockets. For the other tested sites, saline irrigation will be performed instead. Then, appointment are given at monthly interval to review the results of the treatment until 3 months. Follow-up care will then be provided as necessary, outside the scope of this study.
Who should enter the study? Compliant adults with severe gum disease and having at least 20 teeth. What will be the benefits of the study?
- To you as a subject? The blood-derived biomaterial may improve gum healing compared to natural unassisted process. The involved procedures will be performed free-of-charge worth around RM 500-4000 as a token of appreciation for your participation. Stipend per appointment will be provided for travel expenses.
- To the investigator? The investigator can evaluate the clinical parameter.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have at least 20 teeth,
- •American Society of Anesthesiology class I or II
- •Periodontitis stages II-IV
- •Bilateral sites of deep periodontal pockets ≥5 mm
排除标准
- •Limited mouth opening or symptomatic temporomandibular joint disorder
- •Inability to tolerate extended long periodontal treatment and/or hyperactive gag reflex
- •Current or former smoker or vape user
- •Pregnant and/or breastfeeding
- •Having diabetes mellitus type I or II
- •Having bleeding disorder or is on anticoagulants
- •Underwent periodontal treatment and/or surgery in past 6 months prior
- •Undergoing orthodontic therapy, or completed in past 3 months prior
- •On or had anti-inflammatory drug(s) in past 3 months prior
- •On or had antibiotic(s) in past 3 months prior
- •Having autoimmune disorder
- •On or had immunosuppressant drug(s) in past 3 months prior
- •Undergoing or underwent radio- and/or chemo-therapy
研究组 & 干预措施
Control half of mouth
Normal saline irrigation after root debridement
干预措施: Normal saline irrigation (Procedure)
Experimental half of mouth
Liquid S-PRF irrigation after root debridement
干预措施: Platelet rich fibrin (Drug)
结局指标
主要结局
Periodontal probing depth
时间窗: Baseline immediately before treatment and 3-months post-operative
Measurement of periodontal pocket depth from gingival margin to base of pocket using UNC-15 probe with and without research stent
Clinical attachment level
时间窗: Baseline immediately before treatment and 3-months post-operative
Sum of measurement of periodontal pocket depth from gingival margin to base of pocket and marginal gingiva level from cementoenamel junction to gingival margin using UNC-15 probe with and without research stent
Number of bleeding sites
时间窗: Baseline immediately before treatment and 3-months post-operative
Record of scored, assessed bleeding after periodontal probing
次要结局
- Full mouth plaque score(Baseline immediately before treatment and monthly up to 3-months post-operative)
- Full mouth bleeding score(Baseline immediately before treatment and monthly up to 3-months post-operative)
- Gingival margin level & relative clinical attachment level(Baseline immediately before treatment and 3-months post-operative)
研究者
Wong Hong Zhang
Dr.
Mahsa University