Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
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.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1: Microsurgical incision closure
Microsurgical approach to wound closure using a digital microscope to enhance view
  • 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%).
    Other names:
    • Microsurgery
No Intervention
Group 2: Dental loupes incision closure
Standard of care surgical approach to wound closure using Dental Loupes.

Recruiting Locations

University of Texas Health Science Center at San Antonio
San Antonio 4726206, Texas 4736286 78229
Contact:
Angela A Palaiologou-Gallis, DDS., MS.
210-567-3567
palaiologoua@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Angela Palaiologou-Gallis, DDS
210-450-3715
PalaiologouA@uthscsa.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.