Enamel Matrix Derivative for Gum Health
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a treatment called Enamel Matrix Derivative (EMD) can promote thicker gum tissue growth around dental implants. Researchers believe EMD can enhance gum health and are evaluating its effectiveness with implants. Participants will either receive this treatment during implant procedures or not, to compare results. Suitable candidates have dental implants ready for a second stage of uncovering and can attend all study visits. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve dental implant outcomes.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude patients who are on anticoagulants (blood thinners).
What prior data suggests that using Enamel Matrix Protein is safe for gum health?
Research has shown that enamel matrix derivatives (EMD) are generally safe for dental procedures. Since 1996, EMD has been used in gum treatments and is approved by the FDA for these purposes. Studies have found that it aids in healing and tissue growth around teeth.
Both animal and human studies support EMD's safety. These studies indicate that EMD promotes gum tissue growth and healing without causing major side effects. Although more research is needed to fully understand its effectiveness, current evidence suggests that EMD is safe and well-tolerated for improving gum health.12345Why are researchers excited about this trial?
Unlike the standard of care for gum health, which often involves cleaning and surgery to remove infected tissue, the enamel matrix derivative (EMD) treatment is derived from enamel matrix proteins that play a key role in tooth development. This treatment is unique because it uses these proteins to stimulate the regeneration of gum tissue and bone, potentially promoting natural healing and repair. Researchers are excited about EMD because it targets the underlying problem by encouraging the body’s own regenerative processes, which could lead to healthier gums without the need for more invasive procedures.
What evidence suggests that Enamel Matrix Protein is effective for improving gum health around implants?
This trial will compare the use of Enamel Matrix Derivative (EMD) with no intervention for gum health. Studies have shown that EMD effectively aids in the healing of gums and bones. Research indicates that EMD can thicken gums around teeth, benefiting overall gum health. Clinical studies have demonstrated positive results in tissue healing with EMD, particularly for bone loss and gum disease. EMD supports the healing process and helps maintain healthier gums, making it a promising option for improving gum health around dental implants.13467
Who Is on the Research Team?
Angela Palaiologou-Gallis, DDS
Principal Investigator
The University of Texas Health Science Center at San Antonio
Are You a Good Fit for This Trial?
This trial is for adults aged 18-89 who need dental implant uncovering and can consent to the study. They must speak English, not be pregnant or planning pregnancy, have no allergies to EMD, not object to animal products, and not be on blood thinners.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
EMD is deposited under the mucosal flap during the second stage implant uncovering
Follow-up
Participants are monitored for mucosal thickness and keratinized mucosal width at one and three months
What Are the Treatments Tested in This Trial?
Interventions
- Enamel Matrix Protein
Trial Overview
The trial is testing if Enamel Matrix Derivative (EMD), a dental material that thickens gum tissue around teeth, also works to thicken gums around implants when used during second stage implant uncovering procedures.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
During implant uncovering the experimental group will receive EMD under the buccal flap
No EMD is administered under the buccal flap during suturing
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San Antonio
Lead Sponsor
Citations
Research progress of enamel matrix derivative on ...
EMD has been demonstrated to facilitate periodontal tissue regeneration, repair damaged bone tissue, and inhibit further bone resorption. Its application has ...
Long‐term clinical outcomes of periodontal regeneration with ...
The present study indicated that regenerative periodontal therapy of intrabony defects using EMD alone yielded positive clinical outcomes that ...
Enamel matrix derivative monotherapy versus combination ...
This systematic review evaluated the effectiveness of combining enamel matrix derivative (EMD) with various bone grafts in periodontal regenerative surgery.
Enamel matrix protein derivatives: role in periodontal ...
Histologic results from animal and human studies have shown that treatment with EMD promotes periodontal regeneration. Moreover, clinical studies have indicated ...
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clinicaltrials.gov
clinicaltrials.gov/study/NCT03972267?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(repair%20palatine))&rank=5&checkSpell=Influence of Enamel Matrix Derivative (Emdogain®) on ...
The objective of this study is to evaluate clinical and patients-centered parameters of 3-month outcome of the enamel-derived matrix (EMD) application on wound ...
The Effect Of Enamel Matrix Derivatives On Gingival Tissue ...
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 ...
Enamel matrix derivative (Emdogain®) for periodontal tissue ...
EMD is an extract of enamel matrix and contains amelogenins of various molecular weights. Amelogenins are involved in the formation of enamel and periodontal ...
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