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Effect of Low-Level Laser on Pain and Healing of Donor Site Following Free Gingival Graft

T

Tehran University of Medical Sciences

Status and phase

Completed
Phase 3
Phase 2

Conditions

Gingival Recession

Treatments

Radiation: Turned-off laser
Radiation: Low-level laser therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02896283
91-01-97-16886

Details and patient eligibility

About

The aim of this randomized split-mouth design clinical trial is to clinically evaluate the effectiveness of diode laser in the healing of donor site of palate in free gingival graft.

Full description

Free gingival graft is the most predictable and successful method for increasing the width of keratinized tissue around teeth/dental implants and vestibular deepening. However, patient discomfort during the healing time is a major disadvantage of this procedure. Several methods have been introduced to accelerate the healing time and reduction of patient's pain during first days after surgery. Low-level lasers have shown promising results in biostimulation of cell growth and differentiation in cultures. However, there are lack of well designed double blind placebo controlled randomized controlled clinical studies evaluating the effects of Low-level laser therapy in acceleration of wound healing and pain relief of patients undergoing free gingival grafts.

Enrollment

12 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • lack of keratinized tissue around teeth (bilateral)

Exclusion criteria

  • patients with systemic diseases
  • non-cooperative patients
  • smokers
  • poor oral hygiene
  • root surface restorations or active caries

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

12 participants in 2 patient groups, including a placebo group

low-level laser therapy
Experimental group
Description:
Low-level laser (Diode, 66o nanometer, power:200 milli Watt (mW), Continuous wave, time of irradiation:32 seconds)is irradiated in donor site
Treatment:
Radiation: Low-level laser therapy
Turned-off laser
Placebo Comparator group
Description:
The same protocol is applied in te donor site, unless the laser is remained off.
Treatment:
Radiation: Turned-off laser

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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