Laser Bandage and Surgical Stent as Palatal Donor Site Dressing After Free Gingival Graft Surgery.

NCT05841641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-05-03

No results posted yet for this study

Summary

The free gingival graft (FGG) procedure is a harvesting technique that creates an open wound that heals by secondary intention. Retarded wound healing, excessive bleeding, and postoperative pain have been reported after FGG procedures. Hemostatic agents include ferric sub-sulfate solution, absorbable synthetic collagen, absorbable gelatin sponge, or oxidized regenerated cellulose. The agents are often combined with a surgical stent designed to cover the donor site, providing protection and pressure hemostasis. Diode laser also exhibits excellent thermal effects with deep tissue penetrative properties, to enhance coagulation. Laser Bandage (LB) could also enhance wound healing and reduce subjective postoperative complications in the palatal donor area after harvesting FGG similarly.

Conditions

  • Palate; Wound

Interventions

DEVICE

Laser Bandage

The Diode Laser will create a biological bandage at a wavelength of 810 nm, set at 5W in continuous-wave mode, applied via a 400-µm optical fibre.

PROCEDURE

Hemostatic agent with surgical stent

Following graft harvesting, the donor site was secured with a hemostatic agent and protected with a palatal stent

Sponsors & Collaborators

  • Krishnadevaraya College of Dental Sciences & Hospital

    lead OTHER

Principal Investigators

  • Prabhuji MLV · Rajiv Gandhi University of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-12
Primary Completion
2022-11-01
Completion
2022-12-01

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05841641 on ClinicalTrials.gov