NCT07053969

The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Enamel 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.

Timeline

• Start date: 2025-08-31
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-07-08
• Last updated: 2025-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study