The Use of a Non-Incised Minimally Invasive Flap Procedure in Conjunction With Emdogain® MI Compared to Traditional SRCP
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Attachment level change.
研究概览
简要总结
This study is designed to evaluate the use of Emdogain® MI in a procedure where a significant portion of the lining of the sulcus is removed by curettage (similar to the traditional clinical procedure described as "gingival curettage") to the point of tissue mobility. This will be designated as a "non-incised minimally invasive flap access procedure". A videoscope will be utilized to assist with the requirement to adequately visualize and debride the root surface. This research project will define the approach used as a "non-incised minimally invasive flap access" approach and will be a modification of recognized minimally invasive techniques. This modification will be made by Dr. Harrel who first describe the minimally invasive periodontal approach and defined minimally invasive periodontal procedures in 1995.
详细描述
The use of a non-incised minimally invasive flap procedure in conjunction with Emdogain MI compared to traditional scaling and root planing.
Background
The product Emdogain® MI is designed for use in a minimally invasive approach to periodontal treatment. This product is being marketed for what is termed a "flapless" procedure whereby scaling and root planing (SRP) is performed, the root surface is "visualized", debrided, and conditioned with EDTA (PrefGel), and then Emdogain® MI is inserted between the root surface and the sulcus tissue to reduce inflammation and stimulate reattachment.
The approach described above has met with mixed success. The concerns are associated with difficulty in the visualization of the sulcus and the difficulty in removing root accretions (calculus) with the "flapless" approach.
Purpose
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
Participants, investigators, and outcome assessors are unaware of the assigned interventions. The care provider will know at this time of procedure what site will receive the intervention and what site will be the control site.
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To participate in this study, you must present:
- •Generalized gum disease with isolated pocket depths of 5 mm to less than 7 mm on bicuspid and cuspid teeth.
- •At least 2 mm of attachment loss.
- •Need to have two similar teeth meeting the criteria for isolated pockets on two other quadrants of the mouth.
- •Need to be between 30 and 75 years of age.
- •Be in good health.
- •Smoke less than 10 cigarettes or equivalent per day.
- •No antibiotics for the past 90 days.
- •Not be taking medications that are known to inhibit or slow healing.
排除标准
- •You are not eligible if:
- •You are pregnant.
- •You are breast feeding.
- •Received gum treatment in the last 6 months.
- •Smoke more than ten cigarettes per day.
- •You have any serious medical conditions.
结局指标
主要结局
Attachment level change.
时间窗: The attachment change will be determined from baseline to the 3 month follow-up and at the 6-month follow-up examination.
Attachment change will be determined by measuring clinical probing depth and gingival marginal level with an UNC probe. The clinical attachment level is the distance from the cemento-enamel junction to the tip of a periodontal probe during periodontal diagnostic probing. The health of the attachment apparatus can affect the measurement.
Probing depth change.
时间窗: Probing depth change will be determined from baseline to the 3 month follow-up and 6 month follow-up.
Probing depth change will be determined with an UNC probe during clinical examination on the control and test sites. Probing depth will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. Probing depth is the distance from the soft tissue (gingiva or alveolar mucosa) margin to the tip of the periodontal probe.
Bleeding on probing change.
时间窗: The bleeding of probing change will be determined from the baseline to the 3 month follow-up and 6 month follow-up.
Bleeding on probing will be determined with an UNC probe during clinical examination on the control and test sites. Bleeding of probing sites will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. Bleeding on probing happens when induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.
Gingival margin level / recession change.
时间窗: Gingival margin level / recession level change will be determined from baseline to the 3 month follow-up and 6 month follow-up.
Gingival margin level / recession will be determined with an UNC probe during clinical examination on the control and test sites. Gingival margin level / recession will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. The migration of the marginal soft tissue to a point apical to the cemento-enamel junction of a tooth or the platform of a dental implant is defined as recession.
Biofilm presence change.
时间窗: Biofilm presence change will be determined from the baseline to the 3 month follow-up and 6 month follow-up.
Biofilm presence will be determined with an UNC probe during clinical examination on the control and test sites. Biofilm will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. Dental plaque is the prototypical example of a biofilm.
次要结局
- VAS pain scale 1 week after appointment.(1 week following the procedure.)
- VAS pain scale 24 hours after appointment.(24 hour follow-up.)
- Time necessary to perform the test procedures(1 day (Time necessary to perform the test procedure at the initial appointment.))