Recruiting

Emdogain® MI & SRCP

Sponsor:

Texas A&M University

Code:

NCT05964699

Conditions

Periodontitis

Attachment Loss, Periodontal

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

Interventions

Minimally invasive periodontal therapy with use of Emdogain

Minimally invasive periodontal therapy without the use of Emdogain

Study Details

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 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

Periodontitis

Attachment Loss, Periodontal

Study ID

NCT05964699

Start date

Jul 31, 2023

Status verified date

Aug, 2024

Completion date

Jul 31, 2025

Anticipated

Primary completion date

Jul 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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 Criteria:

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.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Minimally 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.

Minimally invasive periodontal therapy without the use of Emdogain

Scaling of root with assisted use of the 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. ]
  • Probing depth change. [ Time Frame: Probing depth change will be determined from baseline to the 3 month follow-up and 6 month follow-up. ]
  • Gingival margin level / recession change. [ Time Frame: Gingival margin level / recession level change will be determined from baseline to the 3 month follow-up and 6 month follow-up. ]
  • Bleeding on probing change. [ Time Frame: The bleeding of probing change will be determined from the baseline to the 3 month follow-up and 6 month follow-up. ]
  • Biofilm presence change. [ Time Frame: Biofilm presence change will be determined from the baseline to the 3 month follow-up and 6 month follow-up. ]

Central Contacts and Locations

Central contacts

Daniel Patrick O Ryan, DDS

2143642857dryan@tamu.edu

Carlos Parra, DDS

6179716788cparra@tamu.edu

Locations

Texas A&M School of Dentistry

Recruiting

Dallas, Texas, United States, 75246

Contacts

Daniel Patrick O Ryan, DDS

214-364-2857dryan@tamu.edu

More Information

Sponsor

Texas A&M University

Last update posted

Aug 21, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas A&M University on 2024-08-21.