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

September 6, 2016 updated by: Neda Moslemi, Tehran University of Medical Sciences

The Effect of Low-Level Laser Therapy on Patient's Pain and Healing of Palatal Donor Site Following Free Gingival Graft: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Radiation: 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
Other Names:
  • low-level laser
Placebo Comparator: Turned-off laser
The same protocol is applied in te donor site, unless the laser is remained off.
Radiation: Turned-off laser
Laser device is turned-off. All parameters are like experimental group, however the laser in turned-off.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
degree of epithelialization
Time Frame: At day 7

3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling

  • Complete epithelialization: bubble was not seen
  • Partial epithelialization: bubbles were seen in lesser than half of donor site
  • No epithelialization: bubble were seen in more than half of donor site
At day 7
degree of epithelialization
Time Frame: At day 14

3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling

  • Complete epithelialization: bubble was not seen
  • Partial epithelialization: bubbles were seen in lesser than half of donor site
  • No epithelialization: bubble were seen in more than half of donor site
At day 14
degree of epithelialization
Time Frame: At day 21

3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling

  • Complete epithelialization: bubble was not seen
  • Partial epithelialization: bubbles were seen in lesser than half of donor site
  • No epithelialization: bubble were seen in more than half of donor site
At day 21

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS) pain score
Time Frame: at day 1
ask from patient about numbers of tablet consumption,record VAS analysis
at day 1
Visual analogue scale (VAS) pain score
Time Frame: at day 2
ask from patient about numbers of tablet consumption,record VAS analysis
at day 2
Visual analogue scale (VAS) pain score
Time Frame: at day 3
ask from patient about numbers of tablet consumption,record VAS analysis
at day 3
Visual analogue scale (VAS) pain score
Time Frame: at day 4
ask from patient about numbers of tablet consumption,record VAS analysis
at day 4
Visual analogue scale (VAS) pain score
Time Frame: at day 5
ask from patient about numbers of tablet consumption,record VAS analysis
at day 5
Visual analogue scale (VAS) pain score
Time Frame: at day 6
ask from patient about numbers of tablet consumption,record VAS analysis
at day 6
Visual analogue scale (VAS) pain score
Time Frame: at day 7
ask from patient about numbers of tablet consumption,record VAS analysis
at day 7
Visual analogue scale (VAS) pain score
Time Frame: at day 14
ask from patient about numbers of tablet consumption,record VAS analysis
at day 14
Clinical healing
Time Frame: at day 1
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
at day 1
Clinical healing
Time Frame: at day 2
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
at day 2
Clinical healing
Time Frame: at day 7
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
at day 7
Clinical healing
Time Frame: at day 14
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
at day 14
Clinical healing
Time Frame: at day 21
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
at day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tehran University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Neda Moslemi, Laser Research Center of Dentistry, Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 91-01-97-16886

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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