Actively Recruiting

Phase Not Applicable
Age: 30Years - 75Years
All Genders
Healthy Volunteers
NCT05964699

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

Led by Texas A&M University · Updated on 2024-08-21

32

Participants Needed

1

Research Sites

104 weeks

Total Duration

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Sponsors

T

Texas A&M University

Lead Sponsor

I

Institut Straumann AG

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 30Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Two similar teeth with isolated pockets in two separate quadrants
  • Age between 30 and 75 years
  • In good general health
  • Smoke less than 10 cigarettes or equivalent per day
  • No antibiotics in the past 90 days
  • Not taking medications known to inhibit or slow healing
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Received gum treatment in the last 6 months
  • Smoke more than 10 cigarettes per day
  • Have any serious medical conditions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Texas A&M School of Dentistry

Dallas, Texas, United States, 75246

Actively Recruiting

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Research Team

D

Daniel Patrick O Ryan, DDS

CONTACT

C

Carlos Parra, DDS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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