Using a surgical microscope to improve gum flap healing
The Effect of Microsurgical Approach to Periodontal Flap Healing: A Randomized Controlled Trial
This study will test whether using a digital surgical microscope helps adults needing periodontal flap surgery heal better than using dental loupes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 18 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT07054008 on ClinicalTrials.gov |
What this trial studies
This is a randomized, two-arm split-mouth trial comparing a microsurgical approach with a digital microscope to the standard surgical approach using dental loupes. Each participant receives both approaches on different sites, so they serve as their own control. The trial uses standardized vertical releasing incisions and random allocation of which side receives the microscope versus loupes. Post-operative wound healing of the incision sites will be measured and compared between the two approaches.
Who should consider this trial
Good fit: Adults aged 18–89 who require surgical periodontal flap treatment (maxillary or mandibular), are ASA I–II, can provide informed consent, and can attend all study visits are ideal candidates.
Not a fit: People who are pregnant, have poorly controlled diabetes (HbA1c > 7.1), require hard-tissue augmentation, are not eligible for periodontal surgery, or are non-English speaking are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the microsurgical approach could lead to faster or stronger healing of periodontal flap incisions and fewer surgical complications.
How similar studies have performed: Prior studies show dental loupes improve surgical outcomes over no magnification, but evidence that higher-magnification surgical microscopes improve periodontal incision healing is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Antonio, Texas
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Angela Palaiologou-Gallis, DDS — The University of Texas Health Science Center at San Antonio
- Study coordinator: Angela Palaiologou-Gallis, DDS
- Email: PalaiologouA@uthscsa.edu
- Phone: 210-450-3715
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.