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RecruitingNCT07053969Updated Nov 12, 2025

The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness

An interventional study of Enamel Matrix Derivative in Dental Implantation, Missing Teeth and Periodontitis, Adult, sponsored by The University of Texas Health Science Center at San Antonio. Recruiting at 1 site in United States. Open to participants aged 18 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-12.

Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 18 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Dental Implantation
  • Missing Teeth
  • Periodontitis, Adult
  • Mucositis

Keywords

  • Enamel Matrix Derivatives
  • EMD
  • Keratinized mucosa width
  • Mucosal thickness
03

In context

Anodontia

85 studies on the registry are indexed under Anodontia; 22 are open to participants now.

This study's planned enrollment of 32 is close to the median of 30 across 61 interventional studies indexed under Anodontia.

Browse Anodontia studies →

Lead sponsor

The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy, or those planning to become pregnant
  2. Allergy or any medical issue using EMD
  3. Non-English speaking
  4. Patients on anticoagulants
  5. Patients who object to the use of animal products
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Group 1: Experimental Group using EMD

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

    Device: Enamel Matrix Derivative

  • No intervention
    Group 2: Control Group

    No EMD is administered under the buccal flap during suturing

Interventions

  • DeviceEnamel Matrix Derivative

    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

06

What researchers measure

Primary outcomes

  1. Mucosal Thickness

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

    Time frame: One month and 3 months

  2. Change in Keratinized mucosal width

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

    Time frame: One month and 3 months

07

Study locations

1 of 1 sites recruiting
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be implemented as appropriate.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07053969
Lead sponsor
The University of Texas Health Science Center at San Antonio
Responsible party
Angela Palaiologou-Gallis, DDS, MS (Professor, The University of Texas Health Science Center at San Antonio) — Principal investigator
First posted
Jul 8, 2025
Start date
Aug 31, 2025
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Nov 12, 2025

Study contacts

Angela Palaiologou-Gallis, DDS
Contact
PalaiologouA@uthscsa.edu
210-450-3715
Angela Palaiologou-Gallis, DDS
principal investigator · The University of Texas Health Science Center at San Antonio

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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