Microsurgery and Periodontal Healing

NCT ID: NCT07054008

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Periodontal Diseases

Keywords

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Surgical flap treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: Microsurgical incision closure

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

Group Type EXPERIMENTAL

Microsurgical approach with Digital Microscope

Intervention Type 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%).

Group 2: Dental loupes incision closure

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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%).

Intervention Type PROCEDURE

Other Intervention Names

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Microsurgery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Angela Palaiologou-Gallis, DDS, MS

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angela Palaiologou-Gallis, DDS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Angela Palaiologou-Gallis, DDS

Role: CONTACT

Phone: 210-450-3715

Email: [email protected]

Facility Contacts

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Angela A Palaiologou-Gallis, DDS., MS.

Role: primary

Other Identifiers

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STUDY00001809

Identifier Type: -

Identifier Source: org_study_id