Free Gingival Graft Adjunct With Low Level Laser Therapy

NCT03425695 | Completed

• 1 other identifier: AIBU
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Free gingival graft, Low level laser therapy, Shrinkage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Epithelization

  7, 14, 21, and 28 days after FGG surgery

Study Arms (2)

Test group

EXPERIMENTAL

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; Other: Clinical examination

Control group

PLACEBO COMPARATOR

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; Other: Clinical examination

Interventions

CheseeTM Diode Laser DEVICE

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

Control group; Test group

Clinical examination OTHER

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; Test group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

MeSH Terms

Conditions

Wounds and Injuries; Gingival Recession

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• AIBU Faculty of Dentistry

  Abant Izzet Baysal University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Model Details: Randomized placebo-controlled parallel design

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 7, 2018
• Study Start: June 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 8, 2018

Record last verified: 2018-01