Enamel matrix derivatives to thicken gum tissue around dental implants
The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness. A Randomized Controlled Trial.
We will test whether applying enamel matrix derivatives under the gum flap during implant uncovering makes gum tissue thicker and increases the width of keratinized mucosa in adults getting dental implants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 18 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT07053969 on ClinicalTrials.gov |
What this trial studies
Adults requiring second-stage implant uncovering at a single center will have enamel matrix derivative (EMD) deposited under the mucosal flap at the time of uncovering, followed by routine flap suturing. An intraoral scan will be obtained after suturing and at one and three months to measure mucosal thickness and keratinized tissue width. Suture removal at 14 days and other postoperative visits follow standard care, and the EMD application adds about 5–10 minutes to the visit. Study participation is completed at the three-month visit when tissue measurements are compared between sites with and without EMD.
Who should consider this trial
Good fit: Adults aged 18 to 89 who require second-stage implant uncovering in the maxillary or mandibular arch, can consent, attend follow-up visits in San Antonio, and are not pregnant, allergic to EMD, on anticoagulants, or opposed to animal products are ideal candidates.
Not a fit: Patients who are pregnant, allergic to EMD, on anticoagulants, object to animal products, cannot speak English, or do not require second-stage uncovering are not eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, this could produce thicker, more stable gum tissue around implants, improving esthetics and long-term implant health.
How similar studies have performed: EMD has been shown to increase gingival thickness around natural teeth in prior work, but its use specifically around implants is less studied and is the focus of this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 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
Where this trial is running
San Antonio, Texas
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Angela Palaiologou-Gallis, DDS — The University of Texas Health Science Center at San Antonio
- Study coordinator: Angela Palaiologou-Gallis, DDS
- Email: PalaiologouA@uthscsa.edu
- Phone: 210-450-3715
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.