Clinical trial NCT03425695: Free Gingival Graft Adjunct With Low Level Laser Therapy
Official title: Free Gingival Graft Adjunct With Low Level Laser Therapy: A Randomized Placebo- Controlled Parallel Group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds and Injuries
Transplants
Gingival Recession, Localized
Low-Level Light Therapy
Keywords: Free gingival graft, Low level laser therapy, Shrinkage
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled parallel design
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Graft shrinkage
timeFrame: 1-, 3-, and 6-months after FGG surgery
Secondary outcomes:
measure: Epithelization
timeFrame: 7, 14, 21, and 28 days after FGG surgery
Other outcomes:
Locations:
Study officials:
affiliation: Abant Izzet Baysal University
name: AIBU Faculty of Dentistry
role: STUDY_CHAIR
References: