The Use of a Non-Incised Minimally Invasive Flap Procedure in Conjunction With Emdogain® MI Compared to Traditional SRCP
Recruiting now · Not applicable
Conditions studied: Periodontitis, Attachment Loss, Periodontal
In brief
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.
Key facts
- Study ID
- NCT05964699
- Run by
- Texas A&M University
- People needed
- 32
- Starts
- 2023-07-31
- Expected to finish
- 2025-07-31
- Last updated by the study team
- 2024-08-21
Who can join
Age: 30 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Texas A&M School of Dentistry — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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