Microsurgery and Periodontal Healing

The University of Texas System (UT)

Status: Enrolling

Conditions: Periodontal Diseases

Treatments: Procedure: Microsurgical approach with Digital Microscope

Study type: Interventional

Funder types: Other

Identifiers

NCT07054008

STUDY00001809

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Group 1: Microsurgical incision closure

Experimental group

Description:

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

Treatment:

Procedure: Microsurgical approach with Digital Microscope

Group 2: Dental loupes incision closure

No Intervention group

Description:

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