Free Gingival Graft Adjunct With Low Level Laser Therapy
NCT ID: NCT03425695
Last Updated: 2018-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2016-06-30
2017-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
CheseeTM Diode Laser
low level laser therapy was utilized adjunct with free gingival graft.
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.
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
CheseeTM Diode Laser
low level laser therapy was utilized adjunct with free gingival graft.
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.
Interventions
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CheseeTM Diode Laser
low level laser therapy was utilized adjunct with free gingival graft.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant or lactating women;
* Patients who underwent periodontal surgery in the study area;
* Patients with orthodontic therapy in progress were excluded.
18 Years
65 Years
ALL
Yes
Sponsors
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Abant Izzet Baysal University
OTHER
Responsible Party
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Sadiye Gunpinar
Asst. Prof. Dr.
Principal Investigators
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AIBU Faculty of Dentistry
Role: STUDY_CHAIR
Abant Izzet Baysal University
Other Identifiers
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AIBU
Identifier Type: -
Identifier Source: org_study_id
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