NCT05841641

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

1.4 years

First QC Date

February 6, 2023

Last Update Submit

April 24, 2023

Conditions

Palate; Wound

Keywords

LASER BANDAGEWOUND HEALING

Outcome Measures

Primary Outcomes (1)

  • EPITHELIALIZATION

    Hydrogen peroxide bubble test

    30 days

Study Arms (2)

Laser Bandage

EXPERIMENTAL

Graft site charred with Diode Laser at 5 Watts to created charred layer

Device: Laser Bandage

Hemostatic agent with surgical stent

EXPERIMENTAL

Graft donor site secured with hemostatic agent with surgical stent

Procedure: Hemostatic agent with surgical stent

Interventions

Laser BandageDEVICE

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.

Also known as: Diode laser (A.R.C- Fox)
Laser Bandage
Hemostatic agent with surgical stentPROCEDURE

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

Also known as: Abgel with surgical stent
Hemostatic agent with surgical stent

Eligibility Criteria

Age22 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients willing to participate in the study.
  • Patients between the age group of 25 to 55 years.
  • Systemically healthy subjects, non-smokers, no record of allergies
  • Patients with esthetic concerns.
  • Patients with palatal mucosa thickness greater than 4mm
  • Absence of periapical or palatal pathologies and the absence of excessive forces (e.g. mechanical forces from orthodontics and traumatic occlusion).
  • Full mouth plaque score (FMPS) \< 20%, Full mouth bleeding score (FMBS) \< 20%.

You may not qualify if:

  • Patients with any systemic diseases.
  • Patients with a history of coagulation disorders.
  • Patients with immunological disorders.
  • Pregnant and lactating females.
  • History of tobacco usage in any form.
  • Patients taking medication that interfere with healing.
  • Patients with palatal mucosa thickness lesser than 2.5mm.
  • Patients who have undergone periodontal surgery within 6 months from the time they enrolled in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

Location

Related Publications (1)

  • Coleton S. Lasers in surgical periodontics and oral medicine. Dent Clin North Am. 2004 Oct;48(4):937-62, vii. doi: 10.1016/j.cden.2004.05.008.

    PMID: 15464559RESULT

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Lasers, SemiconductorHemostasis

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and SuppliesBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Prabhuji MLV

    Rajiv Gandhi University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2023

First Posted

May 3, 2023

Study Start

June 12, 2021

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)