Actively Recruiting

Phase Not Applicable
Age: 18Years - 18Years
All Genders
Healthy Volunteers
ID07053969

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

Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-11-12

32

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of Enamel Matrix Derivatives (EMD) on the thickness of gum tissue around dental implants. The study tests whether applying EMD under the gum flap during implant uncovering increases mucosal tissue thickness and keratinized tissue width compared to not using EMD. This is a randomized controlled trial sponsored by The University of Texas Health Science Center at San Antonio. Participants will be divided into two groups: one receiving EMD applied under the gum flap during the second stage implant uncovering, and the other receiving no EMD. The EMD application adds about 5 to 10 minutes to the procedure. All patients will have follow-up visits at 14 days for suture removal, and at one and three months for intraoral scans to assess soft tissue changes. The study treatment is performed during routine implant care. Participants will undergo intraoral scans at one and three months after treatment to measure mucosal thickness and changes in keratinized mucosal width. Follow-up visits coincide with standard care appointments, minimizing extra visits. Study participation concludes at the three-month visit, during which researchers collect important data to evaluate the impact of EMD on gum tissue around implants.

CONDITIONS

Brief Title

The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness

Who Can Participate

Age: 18Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability of subject to understand and willingness to sign informed consent
  • Males and females aged 18 to 89 years
  • Require second stage implant uncovering
  • Implant located in either the maxillary or mandibular arch
  • Consistent transportation for all clinical and study visits
Not Eligible

You will not qualify if you...

  • Pregnancy or planning to become pregnant
  • Allergy or medical issues using Enamel Matrix Derivative
  • Non-English speaking
  • Use of anticoagulant medications
  • Objection to the use of animal products in treatment materials or procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Single day procedure

Participants undergo the second stage implant uncovering procedure during which the experimental group receives enamel matrix derivative (EMD) under the buccal flap prior to suturing.

1 visit (in-person)

Post-operative Follow-up

Duration - 3 months

Participants have follow-up visits for suture removal and intraoral scans to evaluate soft tissue dimensions. The suture removal occurs at 14 days per standard care. Intraoral scans occur at one and three months, adding approximately 5 to 10 minutes to regular postoperative visits.

3 visits (in-person) including suture removal at 14 days and follow-ups at 1 month and 3 months

Trial Site Locations

Total: 1 location

1

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States, 78229

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Research Team

A

Angela Palaiologou-Gallis, DDS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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