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

NCT ID: NCT02896283

Last Updated: 2016-09-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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low-level laser therapy

Low-level laser (Diode, 66o nanometer, power:200 milli Watt (mW), Continuous wave, time of irradiation:32 seconds)is irradiated in donor site

Group Type EXPERIMENTAL

Low-level laser therapy

Intervention Type RADIATION

Low-level laser therapy with the following parameters: Wavelength:660 nanometer, power: 200 mW, continuous mode, tme of irradiation: 32 seconds

Turned-off laser

The same protocol is applied in te donor site, unless the laser is remained off.

Group Type PLACEBO_COMPARATOR

Turned-off laser

Intervention Type RADIATION

Laser device is turned-off. All parameters are like experimental group, however the laser in turned-off.

Interventions

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Low-level laser therapy

Low-level laser therapy with the following parameters: Wavelength:660 nanometer, power: 200 mW, continuous mode, tme of irradiation: 32 seconds

Intervention Type RADIATION

Turned-off laser

Laser device is turned-off. All parameters are like experimental group, however the laser in turned-off.

Intervention Type RADIATION

Other Intervention Names

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low-level laser Placebo

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Neda Moslemi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neda Moslemi

Role: STUDY_DIRECTOR

Laser Research Center of Dentistry, Tehran University of Medical Sciences

Locations

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Neda Moslemi

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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91-01-97-16886

Identifier Type: -

Identifier Source: org_study_id

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