Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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)
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
Actively Recruiting
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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