The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness

NCT07053969 | Recruiting FDA Device

• 1 other identifier: 00001758
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implantation; Missing Teeth; Periodontitis, Adult; Mucositis

Keywords

Enamel Matrix Derivatives; EMD; Keratinized mucosa width; Mucosal thickness

Outcome Measures

Primary Outcomes (2)

• Mucosal Thickness

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

  One month and 3 months

• Change in Keratinized mucosal width

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

  One month and 3 months

Study Arms (2)

Group 1: Experimental Group using EMD

EXPERIMENTAL

During implant uncovering the experimental group will receive EMD under the buccal flap

Device: Enamel Matrix Derivative

Group 2: Control Group

NO INTERVENTION

No EMD is administered under the buccal flap during suturing

Interventions

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.

Also known as: EMD

Group 1: Experimental Group using EMD

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Anodontia; Chronic Periodontitis; Mucositis

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Periodontitis; Periodontal Diseases; Mouth Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Angela Palaiologou-Gallis, DDS

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Palaiologou-Gallis, DDS

CONTACT

210-450-3715; PalaiologouA@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Prior to the beginning of the surgical procedure, the PI will request that a faculty member not involved in the case randomly select a sealed envelope and hand it to the resident completing the procedure. The surgeon will not be blinded as it is not possible since only the experimental group will only receive the EMD.The patients will be blinded as to which group they are randomized into.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A two-arm randomized controlled trial

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At the conclusion of the study after data analysis is complete and the research is published in a peer reviewed journal

Locations

US (1)