Dental ImplantationNCT07053969
The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness
A study testing Enamel Matrix Derivative in people with Dental Implantation and Missing Teeth, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implantation, Missing Teeth, Periodontitis, Adult
- What is being tested?
- Enamel Matrix Derivative
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Angela A Palaiologou-Gallis, DDS., MS., 210-567-3567, palaiologoua@uthscsa.edu
About this study
Official title: The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness. A Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Dental Implantation, Missing Teeth, Periodontitis, Adult, Mucositis
- Being tested
- Enamel Matrix Derivative
- Keywords
- Enamel Matrix Derivatives, EMD, Keratinized mucosa width, Mucosal thickness
- Medical subject headings
- Anodontia, Chronic Periodontitis, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enamel Matrix DerivativeDevice
Also called EMD
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Experimental Group using EMD | Experimental | During implant uncovering the experimental group will receive EMD under the buccal flap Receives: Device: Enamel Matrix Derivative |
| Group 2: Control Group | No intervention | No EMD is administered under the buccal flap during suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal Thickness
Mucosal thickness at 1 and 5mm below the free gingival margin will be measured
Measured: One month and 3 months
Change in Keratinized mucosal width
measurement of keratinized mucosal width at one and three months after surgical uncovering of the dental implant
Measured: One month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start31 Aug 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Palaiologou-Gallis, DDS, MS, The University of Texas Health Science Center at San Antonio
- Investigators
- Angela Palaiologou-Gallis, DDS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053969
- Sponsor's protocol ID
- 00001758
- Status last verified
- Nov 2025
- First submitted
- 27 Jun 2025
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be implemented as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07053969
- Acronym / sponsor ID
- 00001758
- Conditions
- Dental Implantation, Missing Teeth, Periodontitis, Adult, Mucositis
- Keywords
- Enamel Matrix Derivatives, EMD, Keratinized mucosa width, Mucosal thickness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 31 Aug 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A two-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group 1: Experimental Group using EMD | Experimental | Device: Enamel Matrix DerivativeDuring implant uncovering the experimental group will receive EMD under the buccal flap |
| Group 2: Control Group | No intervention | –No EMD is administered under the buccal flap during suturing |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enamel Matrix DerivativeAlso: EMDEMD 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. | Device | Group 1: Experimental Group using EMD |
Primary outcome
Mucosal Thickness
Time frame: One month and 3 months
Mucosal thickness at 1 and 5mm below the free gingival margin will be measured
Change in Keratinized mucosal width
Time frame: One month and 3 months
measurement of keratinized mucosal width at one and three months after surgical uncovering of the dental implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Individual participant dataSharing planned: Yes. The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be implemented as appropriate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Palaiologou-Gallis, DDS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enamel Matrix Derivative in people with Dental Implantation and Missing Teeth, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Palaiologou-Gallis, DDS (210-450-3715, PalaiologouA@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucosal Thickness (time frame: One month and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.