Free Gingival Graft Adjunct With Low Level Laser Therapy

Free Gingival Graft Adjunct With Low Level Laser Therapy: A Randomized Placebo- Controlled Parallel Group Study

The present placebo-controlled parallel design clinical study was planned to determine the effect of low level laser therapy on clinical periodontal conditions and dimensions of free gingival graft as well as postoperative pain levels in the surgical area.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Low-Level Light Therapy; Gingival Recession, Localized; Transplants
• Intervention / Treatment: Device: CheseeTM Diode Laser; Other: Clinical examination

Detailed Description

Background: Shrinkage of the free gingival graft (FGG) and patient's discomfort during healing period are important concerns. Therefore, this study aimed to evaluate the effect of low level laser therapy (LLLT) in terms of enhancing wound healing, reducing graft shrinkage and postoperative pain.

Methods: Thirty patients were randomly assigned to receive either FGG+ LLLT (test, n = 15) or FGG + placebo LLLT (control, n = 15). In the test group, a diode laser (aluminum-gallium-arsenide, 810 nm, 0.1 W, continuous mode, time of irradiation:60 s, energy density: 6 J/cm2, spot size:0.5 cm) was applied immediately after the FGG surgery and 1,3,7, and 14 days later. The control group received the same sequence of irradiation with the laser-off. Comparison of the graft surface areas between groups at 1st, 3rd and 6th months were made with an image-analyzing software. Complete wound epithelization, visual analogue scale (VAS) pain score of recipient site and the number of analgesic used were evaluated after the surgery.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients >18 years old
• Patients presenting Class I or II Miller gingival recession on vital incisors in the mandibular anterior region with no caries or restoration
• The included teeth had also keratinized gingiva <2 mm; PI and GI<1.
• The patients had to be systemically healthy and non-smokers.

Exclusion Criteria:

• Patients presenting active periodontal disease and probing depth >3 mm; taking medications that would interfere with the wound-healing process or that contraindicate the surgical procedure;
• Pregnant or lactating women;
• Patients who underwent periodontal surgery in the study area;
• Patients with orthodontic therapy in progress were excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; Free Gingival Graft (FGG) + Low Level Laser Therapy (LLLT) + Clinical Examination The test group received LLLT with a diode laser (CheseeTM Diode Laser, Wuhan, China ) at the FGG sites with a wavelength of 810 nm and output power of 0.1 W, for 60 s, with an energy density of 6 J/cm2 in the continuous wave mode (spot size:0.5 cm). The laser beam was directed perpendicularly toward the tissue in the noncontact mode. The laser was irradiated at the recipient sites immediately after surgery and 1, 3, 7, and 14 days later.	Device: CheseeTM Diode Laser; low level laser therapy was utilized adjunct with free gingival graft.; Other: Clinical examination; The shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd, and 6th months. Epithelization was determined via bubbling test by using 3% hydrogen peroxide (H2O2) at 7, 14, 21, and 28 days after surgery.
Placebo Comparator: Control group; Free Gingival Graft (FGG)+Placebo Low Level Laser Therapy (PLLLT) + Clinical Examination The control group received PLLLT with a diode laser (CheseeTM Diode Laser, Wuhan, China ) same as test group without pushing the start button	Device: CheseeTM Diode Laser; low level laser therapy was utilized adjunct with free gingival graft.; Other: Clinical examination; The shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd, and 6th months. Epithelization was determined via bubbling test by using 3% hydrogen peroxide (H2O2) at 7, 14, 21, and 28 days after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft shrinkage	The shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd, and 6th months.	1-, 3-, and 6-months after FGG surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epithelization	Epithelization was determined via bubbling test by using 3% hydrogen peroxide (H2O2). This test was carried out at 7, 14, 21, and 28 days after surgery.	7, 14, 21, and 28 days after FGG surgery

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University
• Investigators: Study Chair: AIBU Faculty of Dentistry, Abant Izzet Baysal University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 8, 2018
• Last Update Submitted That Met QC Criteria: February 7, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Free gingival graft, Low level laser therapy, Shrinkage
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Wounds and Injuries; Gingival Recession
• Other Study ID Numbers: AIBU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No