The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Between 18 Years and 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
A two-arm randomized controlled trial
Primary Purpose
Treatment
Masking
Single (Participant)
Masking Description
Prior to the beginning of the surgical procedure, the PI will request that a faculty member not involved in the case randomly select a sealed envelope and hand it to the resident completing the procedure. The surgeon will not be blinded as it is not possible since only the experimental group will only receive the EMD.The patients will be blinded as to which group they are randomized into.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1: Experimental Group using EMD 		During implant uncovering the experimental group will receive EMD under the buccal flap
  • 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.
    Other names:
    • EMD
No Intervention
Group 2: Control Group 		No EMD is administered under the buccal flap during suturing

Recruiting Locations

University of Texas Health Science Center at San Antonio
San Antonio 4726206, Texas 4736286 78229
Contact:
Angela A Palaiologou-Gallis, DDS., MS.
210-567-3567
palaiologoua@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Angela Palaiologou-Gallis, DDS
210-450-3715
PalaiologouA@uthscsa.edu

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.