Microsurgery and Periodontal Healing

The University of Texas Health Science Center at San Antonio25 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Periodontal Diseases

Interventions

Microsurgical approach with Digital MicroscopePROCEDURE

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%).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Early wound healing index

Assessment of early soft tissue wound healing

Time frame: One, two and three weeks

Secondary Outcomes

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.

Time frame: End of surgical procedure at last suture placement

Central Contacts

Angela Palaiologou-Gallis, DDS

CONTACT

210-450-3715 PalaiologouA@uthscsa.edu

Data from ClinicalTrials.gov

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