Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07053969

The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness

Scientists do research to answer important questions which might help change or improve the way we do things in the future.

The investigators know that using Enamel Matrix Derivatives results in thicker gum tissues around teeth. This study will test to see if using EMD around implants results in thicker gum tissues around implants.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location status: Recruiting

Location contact

Angela A Palaiologou-Gallis, DDS., MS.

CONTACT

[email protected]

210-567-3567

About this study

The hypothesis of the study is that the addition of EMD under the gingival flap prior to suturing will result in increased mucosal tissue thickness and increased keratinized tissue width as compared to not using the EMD.

The EMD will be deposited under the mucosal flap during the second stage implant uncovering. After flap suturing, an intraoral scan will be obtained. This procedure will require approximately 5 - 10 minutes per patient. All patients will be followed up at 14 days for suture removal per standard of care and not as part of the study. All patients will be followed up at one and three months per standard of care during which visits they will undergo an intraoral scan to allow evaluation of soft tissue dimensions. This is research only procedure that is expected to add 5 - 10 minutes to the regular postoperative visit. Study participation will be completed at the 3-month visit.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability of subject to understand and the willingness to sign a written informed consent document.
  • Males and females; Age 18 to 89 years old
  • Require second stage implant uncovering
  • In either the maxillary or mandibular arch
  • Has consistent transportation for all clinical and study visits

Exclusion criteria

  • Pregnancy, or those planning to become pregnant
  • Allergy or any medical issue using EMD
  • Non-English speaking
  • Patients on anticoagulants
  • Patients who object to the use of animal products

Treatment and study plan

Enamel Matrix Derivative

Device

EMD is an FDA approved medical device used in periodontal procedures since 1996. It has been shown to enhance soft and hard tissue healing, increased root coverage and aid in periodontal regeneration. It's use as an adjunct during implant uncovering may increase peri-implant mucosal thickness.

Other names: EMD

Primary outcomes

  1. Mucosal Thickness

    Time frame: One month and 3 months

    Mucosal thickness at 1 and 5mm below the free gingival margin will be measured

  2. Change in Keratinized mucosal width

    Time frame: One month and 3 months

    measurement of keratinized mucosal width at one and three months after surgical uncovering of the dental implant

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Palaiologou-Gallis, DDS

CONTACT

[email protected]

210-450-3715

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness. A Randomized Controlled Trial.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2025
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.