Periodontal Diseases
Conditions
Keywords
Surgical flap treatment
Brief 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 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.
Detailed description
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.
Interventions
PROCEDUREMicrosurgical approach with Digital Microscope
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%).
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ability of subject to understand and the willingness to sign a written informed consent document. 2. Males and females; Age 18 -89 years old 3. Require surgical flap treatment of periodontal disease 4. Either maxillary or mandibular arch 5. ASA I or II 6. Has consistent transportation for all clinical and study visits
Exclusion criteria
1. Pregnancy, or those planning to become pregnant 2. Diabetics with an HbA1c \>7.1 3. Not eligible for surgical periodontal therapy 4. Require vertical or horizontal hard tissue augmentation 5. Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early wound healing index | One, two and three weeks | Assessment of early soft tissue wound healing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in time between procedures | End of surgical procedure at last suture placement | 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. |
Countries
United States
Contacts
Primary ContactAngela Palaiologou-Gallis, DDS
Outcome results
None listed