Microsurgery and Periodontal Healing

NCT07054008 | Recruiting

• 1 other identifier: STUDY00001809
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Keywords

Surgical flap treatment

Outcome Measures

Primary Outcomes (1)

• Early wound healing index

  Assessment of early soft tissue wound healing

  One, two and three weeks

Secondary Outcomes (1)

• Difference in time between procedures

  End of surgical procedure at last suture placement

Study Arms (2)

Group 1: Microsurgical incision closure

EXPERIMENTAL

Microsurgical approach to wound closure using a digital microscope to enhance view

Procedure: Microsurgical approach with Digital Microscope

Group 2: Dental loupes incision closure

NO INTERVENTION

Standard of care surgical approach to wound closure using Dental Loupes.

Interventions

Microsurgical approach with Digital Microscope PROCEDURE

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%).

Also known as: Microsurgery

Group 1: Microsurgical incision closure

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Microsurgery

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Micromanipulation; Investigative Techniques

Study Officials

• Angela Palaiologou-Gallis, DDS

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Palaiologou-Gallis, DDS

CONTACT

210-450-3715; PalaiologouA@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At the conclusion of the study after data analysis is complete and the research is published in a peer reviewed journal

Locations

US (1)