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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 glasses with special attachments that provide magnification (dental loupes) for dental procedures results in better healing than not using magnification. This study will test if using a microscope, that gives much higher magnification, can result in even better healing than using dental loupes.
A two-arm split mouth randomized controlled trial investigating the effect of using an experimental microsurgical approach with a digital microscope (Group 1) or standard of care surgical approach with dental loupes (Group 2) on post-operative wound healing of two standardized vertical releasing incisions. The split mouth design will ensure that each patient serves as their own control.
The hypothesis is that the wound closure technique in Group 1: Microsurgical approach with digital microscope will have improved periodontal flap vertical releasing incision wound healing as compared to the Group 2: Standard of Care surgical approach with dental loupes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Microsurgical incision closure | Experimental | Microsurgical approach to wound closure using a digital microscope to enhance view |
|
| Group 2: Dental loupes incision closure | No Intervention | Standard of care surgical approach to wound closure using Dental Loupes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microsurgical approach with Digital Microscope | Procedure | The incision will be sutured with the use of a digital microscope (30 X) (Group 1). The microsurgical approach is a research only procedure that may add time to the total surgical time (< 6%). |
| Measure | Description | Time Frame |
|---|---|---|
| Early wound healing index | Assessment of early soft tissue wound healing | One, two and three weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in time between procedures | The time needed for suturing the incision with the digital microscope (Group 1) and with standard of care dental loupes (Group 2) will be documented immediately after placement of the last suture. | End of surgical procedure at last suture placement |
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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 |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D008866 | Microsurgery |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D008846 | Micromanipulation |
| D008919 | Investigative Techniques |
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A two-arm randomized controlled split-mouth trial. Subjects will be randomized only for the first (mesial) incision to Group 1 (microscope) or Group 2 (dental loupes). The second incision (distal) will receive the other treatment. Every patient will receive both treatments.
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