Dental Implantation, Missing Teeth, Mucositis, Periodontitis, Adult
Conditions
Keywords
Enamel Matrix Derivatives, EMD, Keratinized mucosa width, Mucosal thickness
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 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.
Interventions
DEVICEEnamel 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.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Intervention model description
A two-arm randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactAngela Palaiologou-Gallis, DDS
Outcome results
None listed