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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Experimental Group using EMD | Experimental | During 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enamel Matrix Derivative | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mucosal Thickness | Mucosal thickness at 1 and 5mm below the free gingival margin will be 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 | One month and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Palaiologou-Gallis, DDS | Contact | 210-450-3715 | PalaiologouA@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Angela Palaiologou-Gallis, DDS | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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.
At the conclusion of the study after data analysis is complete and the research is published in a peer reviewed journal
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| ID | Term |
|---|---|
| D000848 | Anodontia |
| D055113 | Chronic Periodontitis |
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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A two-arm randomized controlled trial
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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.
|
|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |