The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enamel Matrix Derivative.
- Who it may be relevant to
- Registry conditions: Dental Implantation, Missing Teeth, Periodontitis, Adult, Mucositis. Basic parameters: 18 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness. A Randomized Controlled Trial.
Overview
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
- 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.
Primary outcome measures
- Mucosal Thickness [Time frame: One month and 3 months]
- Change in Keratinized mucosal width [Time frame: One month and 3 months]
Eligibility criteria
Inclusion criteria
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Males and females; Age 18 to 89 years old
- Require second stage implant uncovering
- In either the maxillary or mandibular arch
- Has consistent transportation for all clinical and study visits
Exclusion criteria
- Pregnancy, or those planning to become pregnant
- Allergy or any medical issue using EMD
- Non-English speaking
- Patients on anticoagulants
- Patients who object to the use of animal products
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Texas Health Science Center at San Antonio — San Antonio
Identifiers
NCT: NCT07053969 · 00001758