The Use of a Non-Incised Minimally Invasive Flap Procedure in Conjunction With Emdogain® MI Compared to Traditional SRCP

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: t
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⁃ 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.

Locations
United States
Texas
Texas A&M School of Dentistry
RECRUITING
Dallas
Contact Information
Primary
Daniel Patrick O Ryan, DDS
dryan@tamu.edu
2143642857
Backup
Carlos Parra, DDS
cparra@tamu.edu
6179716788
Time Frame
Start Date: 2023-07-31
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 32
Treatments
Experimental: Periodontal regeneration
Regeneration will be attempted during root scaling and planing with the application of Emdogain and the use of a Videoscope.
Placebo_comparator: Control
The control group will receive standard-of-care root scaling and planing without the application of Emdogain and the use of a Videoscope.
Related Therapeutic Areas
Sponsors
Leads: Texas A&M University
Collaborators: Institut Straumann AG

This content was sourced from clinicaltrials.gov