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

Not Applicable

Not yet recruiting

• Conditions: Dental Implantation; Missing Teeth; Periodontitis, Adult; Mucositis

• Registration Number: NCT07053969
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief 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 ("EMD", a commonly used dental material) 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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-27
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Study Start: 2025-08-01
• Primary Completion: 2027-09
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mucosal Thickness	One month and 3 months	Mucosal thickness at 1 and 5mm below the free gingival margin will be measured
Change in Keratinized mucosal width	One month and 3 months	measurement of keratinized mucosal width at one and three months after surgical uncovering of the dental implant

Trial Locations

Locations (1)

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States