Free Gingival Graft Adjunct With Low Level Laser Therapy

February 7, 2018 updated by: Sadiye Gunpinar, Abant Izzet Baysal University

Free Gingival Graft Adjunct With Low Level Laser Therapy: A Randomized Placebo- Controlled Parallel Group Study

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.

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

Background: Shrinkage of the free gingival graft (FGG) and patient's discomfort during healing period are important concerns. Therefore, this study aimed to evaluate the effect of low level laser therapy (LLLT) in terms of enhancing wound healing, reducing graft shrinkage and postoperative pain.

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.

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.
30

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.
  • Not Applicable

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: Parallel Assignment
  • Masking: Triple

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: 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.
Device: CheseeTM Diode Laser
low level laser therapy was utilized adjunct with free gingival graft.
Other: 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.
Placebo Comparator: 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
Device: CheseeTM Diode Laser
low level laser therapy was utilized adjunct with free gingival graft.
Other: 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.

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
Graft shrinkage
Time Frame: 1-, 3-, and 6-months after FGG surgery
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 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
Epithelization
Time Frame: 7, 14, 21, and 28 days after FGG surgery
Epithelization was determined via bubbling test by using 3% hydrogen peroxide (H2O2). This test was carried out at 7, 14, 21, and 28 days after surgery.
7, 14, 21, and 28 days after FGG surgery

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.
Abant Izzet Baysal University

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 Chair: AIBU Faculty of Dentistry, Abant Izzet Baysal University

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 (Actual)

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.
June 1, 2016

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.
September 1, 2017

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.
September 1, 2017

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).
January 26, 2018

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.
February 1, 2018

First Posted (Actual)

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.
February 7, 2018

Study Record Updates

Last Update Posted (Actual)

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.
February 8, 2018

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.
February 7, 2018

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.
January 1, 2018

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.
  • AIBU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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