Free Gingival Graft Adjunct With Low Level Laser Therapy

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03425695
• Other study ID #: AIBU
• Status: Completed
• Phase: N/A
• First received: January 26, 2018
• Last updated: February 7, 2018
• Start date: June 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recession, Localized
• Low-Level Light Therapy
• Transplants
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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