Status:

RECRUITING

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

Lead Sponsor:

Texas A&M University

Collaborating Sponsors:

Institut Straumann AG

Conditions:

Periodontitis

Attachment Loss, Periodontal

Eligibility:

All Genders

30-75 years

Phase:

NA

Brief 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...

Detailed Description

The use of a non-incised minimally invasive flap procedure in conjunction with Emdogain MI compared to traditional scaling and root planing. Background The product Emdogain® MI is designed for use i...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 31 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 31 2025

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT05964699

Start Date

July 31 2023

End Date

July 31 2025

Last Update

August 21 2024

Active Locations (1)

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1

Texas A&M School of Dentistry

Dallas, Texas, United States, 75246