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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03425695
Enrollment
30
Registered
2018-02-07
Start date
2016-06-30
Completion date
2017-09-30
Last updated
2018-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Free gingival graft, Low level laser therapy, Shrinkage

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.

Interventions

DEVICECheseeTM Diode Laser

low level laser therapy was utilized adjunct with free gingival graft.

OTHERClinical 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.

Sponsors

Abant Izzet Baysal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Randomized placebo-controlled parallel design

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Graft shrinkage1-, 3-, and 6-months after FGG surgeryThe shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd, and 6th months.

Secondary

MeasureTime frameDescription
Epithelization7, 14, 21, and 28 days after FGG surgeryEpithelization 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026