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The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness

NCT ID: NCT07053969

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2027-09-30

Brief Summary

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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

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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.

Conditions

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Dental Implantation Missing Teeth Periodontitis, Adult Mucositis

Keywords

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Enamel Matrix Derivatives EMD Keratinized mucosa width Mucosal thickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A two-arm randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Group 1: Experimental Group using EMD

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

Group Type EXPERIMENTAL

Enamel Matrix Derivative

Intervention Type DEVICE

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.

Group 2: Control Group

No EMD is administered under the buccal flap during suturing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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EMD

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Angela Palaiologou-Gallis, DDS, MS

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angela Palaiologou-Gallis, DDS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Angela Palaiologou-Gallis, DDS

Role: CONTACT

Phone: 210-450-3715

Email: [email protected]

Facility Contacts

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Angela A Palaiologou-Gallis, DDS., MS.

Role: primary

Other Identifiers

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00001758

Identifier Type: -

Identifier Source: org_study_id