Microsurgery and Periodontal Healing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Microsurgical approach with Digital Microscope.
- Who it may be relevant to
- Registry conditions: Periodontal Diseases. Basic parameters: 18 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Microsurgical Approach to Periodontal Flap Healing: A Randomized Controlled Trial
Overview
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
- Procedure Microsurgical 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%).
Primary outcome measures
- Early wound healing index [Time frame: One, two and three weeks]
Secondary outcome measures (1)
- Difference in time between procedures [Time frame: End of surgical procedure at last suture placement]
Eligibility criteria
Inclusion criteria
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Males and females; Age 18 -89 years old
- Require surgical flap treatment of periodontal disease
- Either maxillary or mandibular arch
- ASA I or II
- Has consistent transportation for all clinical and study visits
Exclusion criteria
- Pregnancy, or those planning to become pregnant
- Diabetics with an HbA1c >7.1
- Not eligible for surgical periodontal therapy
- Require vertical or horizontal hard tissue augmentation
- Non-English speaking
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Texas Health Science Center at San Antonio — San Antonio
Identifiers
NCT: NCT07054008 · STUDY00001809