RecruitingNot ApplicableNCT05964699

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


Sponsor

Texas A&M University

Enrollment

32 participants

Start Date

Jul 31, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 30 YearsMax Age: 75 Years

Inclusion Criteria9

  • 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.

Exclusion Criteria6

  • 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.

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Interventions

PROCEDUREMinimally invasive periodontal therapy with use of Emdogain

Scaling of root with assisted use of the Videoscope and regrowth of attachment by the use of Emdogain.

PROCEDUREMinimally invasive periodontal therapy without the use of Emdogain

Scaling of root with assisted use of the Videoscope.


Locations(1)

Texas A&M School of Dentistry

Dallas, Texas, United States

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NCT05964699


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