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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Texas A&M University
Study ID
NCT05964699
Status
Recruiting
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Conditions

  • Attachment Loss, Periodontal
  • Periodontitis

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Minimally invasive periodontal therapy with use of Emdogain — PROCEDURE
    Scaling of root with assisted use of the Videoscope and regrowth of attachment by the use of Emdogain.
  • Minimally invasive periodontal therapy without the use of Emdogain — PROCEDURE
    Scaling of root with assisted use of the Videoscope.

Study Details

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 Dates

Start date
Jul 31, 2023
Status verified
Aug 2024
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Attachment level change. [ Time Frame: The attachment change will be determined from baseline to the 3 month follow-up and at the 6-month follow-up examination. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas A&M School of DentistryDallasTexas75246
Daniel Patrick O Ryan, DDS
[email protected]
214-364-2857

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By research site
Texas A&M School of Dentistry· Dallas, TX

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