The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness

The University of Texas System (UT)

Status: Enrolling

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

Treatments: Device: Enamel Matrix Derivative

Study type: Interventional

Funder types: Other

Identifiers

NCT07053969

00001758

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

32 participants in 2 patient groups

Group 1: Experimental Group using EMD

Experimental group

Description:

During implant uncovering the experimental group will receive EMD under the buccal flap

Treatment:

Device: Enamel Matrix Derivative

Group 2: Control Group

No Intervention group

Description:

No EMD is administered under the buccal flap during suturing