Photobiomodulation of Palatal Donor Site After Free Gingival Graft Removal

December 23, 2021 updated by: Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

Comparison of Two Energy Densities for Photobiomodulation of Palatal Donor Site After Free Gingival Graft Removal. Randomized Clinical Trial

The aim of this study is to compare the influence of two different energy densities for photobiomodulation on recovery of palatal donor area after free gingival graft technique.

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

This is a prospective, parallel and controlled clinical trial. The population evaluated in the study was selected at Science and Technology Institute (STI) -São José dos Campos, College of Dentistry.

Patients were assigned to one of the three treatment groups:

  • Group 1: ridge preservation surgery through free gingival graft and photobiomodulation (PBM) application through a gallium aluminum arsenide laser (GaAlAs) in the donor area using a 60 Joule/cm² dose
  • Group 2: ridge of preservation surgery through free gingival graft and PBM through a gallium aluminum arsenide laser (GaAlAs) in the donor area using a 15 Joule/cm² dose
  • Group 3: ridge preservation surgery through free gingival graft and PBM Sham.

All surgeries were performed by the same expert periodontist (MPS). A blade 15c (Swann-Morton® - Sheffield, England) mounted on No. 3 scalpel handle will make an intrasulcular incision around the tooth indicated for exodontia. Then, the tooth will be extracted through the use of appropriate instruments in order to obtain a minimally traumatic exodontia.

After the exodontia, curettage and irrigation of the dental socket will be performed. After that, the socket will be filled with xenogenous bone graft (GenOx Inorg; Campinas, SP), and sealed with a free gingival graft removed from the palate. For the free gingival graft removal, a circular template of 5 millimeters in diameter will be used. This mold has the objective of standardizing the palatal graft removal ensuring the wounds will have always the same size. After the circular incision, the graft will be removed with a thickness of 2 millimeters. After free gingival graft removal from palate, it will be adjusted to the entrance of the socket and sutured with Vicryl® 5.0 reabsorbable (Ethicon Johnsons do Brasil, São José dos Campos - SP).

The evaluated parameters were wound remaining area (WRA), scar and tissue colorimetry (TC), tissue thickness (TT) and postoperative discomfort (D), evaluated at baseline and 7, 14, 45, 60, and 90 days after surgery.

Statistical Analysis: All data were expressed as mean ± standard deviation or expressed in percentages during the descriptive phase. Data were analyzed according to distribution by the Shapiro-Wilk test. For the remaining wound area, tissue colorimetry, tissue thickness, and postoperative discomfort parameter analysis, two way repeated measures ANOVA was performed for intra- and intergroup analysis. T test was used for intergroup comparison of the number of analgesics taken. The presence or absence of scars was measured by Q-square test. Statistical analysis was performed using Sigma Plot 12.0. In all tests a significance level of 0.05 was chosen.

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.
45

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

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

  • Brazil
    • São Paulo
      • Sao Jose dos Campos, São Paulo, Brazil, 12243-700
        • Felipe Lucas da Silva Neves

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients presenting indication of anterior maxillary exodontia (15 to 25), with normal gingival contour in the teeth indicated for exodontia; The tooth included in the study, as well as the adjacent teeth do not present a loss of periodontal insertion.
  • Patients agreed to and signed the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the present study (Resolution no. 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - 179/93).

Exclusion Criteria:

  • Were excluded patients with systemic problems that contraindicated surgical procedure
  • Those under medication that could interfere with the wound healing
  • Those who smoked
  • Those who were pregnant or lactating, and
  • Those who had had periodontal surgery on the study area.

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.
Sham Comparator: Free gingival graft + PBM Sham
The patients allocated to the control group will receive sham irradiation. For this, black rubber protection will be placed at the tip of the laser device, which do not allow the light to reach the tissue. The applications will be performed by a different operator from the one who will measure the study parameters. During irradiation, the tip of the laser probe will be placed perpendicularly with slight contact on the area. Laser therapy will be initiated in the immediate postoperative period (just after sutures) and will be repeated by four more applications performed every other day, with a total of 5 laser applications.
Procedure: Free gingival graft
Free gingival graft removal from palate for socket preservation
Other Names:
  • Socket preservation
Device: GaAlAs laser
Utilization of GaAlAs laser to irradiation on the palatal donor site for photobiomodulation
Other Names:
  • Low level GaAlAs laser
Experimental: Free gingival graft + GaAlAs Laser 60
The irradiation will be performed with a GaAlAs diode laser that continuously emits a wavelength of 660 nm with a power of 30 milliwatts (mW). The patients allocated for the group 60 will receive the following protocol for laser application: Five (5) points of irradiation will be performed using a total energy density (fluence) of 60 Joules/cm2 and a time of 56 seconds per point (1,68 Joules/cm2 per point). During irradiation, the tip of the laser probe will be placed perpendicularly with slight contact on the area. Laser therapy will be initiated in the immediate postoperative period (just after sutures) and will repeated by four more applications performed every other day, with a total of 5 laser applications. The power of the equipment will be calibrated prior to each application.
Procedure: Free gingival graft
Free gingival graft removal from palate for socket preservation
Other Names:
  • Socket preservation
Device: GaAlAs laser
Utilization of GaAlAs laser to irradiation on the palatal donor site for photobiomodulation
Other Names:
  • Low level GaAlAs laser
Experimental: Free gingival graft + GaAlAs Laser 15
The irradiation will be performed with a GaAlAs diode laser that continuously emits a wavelength of 660 nm with a power of 30 milliwatts (mW). The patients allocated for the group 15 will receive the following protocol for laser application: Five (5) points of irradiation will be performed using a total energy density (fluence) of 15 Joules/cm2 and a time of 14 seconds per point (0,42 Joules/cm2 per point). During irradiation, the tip of the laser probe will be placed perpendicularly with slight contact on the area. Laser therapy will be initiated in the immediate postoperative period (just after sutures) and will be repeated by four more applications performed every other day, with a total of 5 laser applications. The power of the equipment will be calibrated prior to each application.
Procedure: Free gingival graft
Free gingival graft removal from palate for socket preservation
Other Names:
  • Socket preservation
Device: GaAlAs laser
Utilization of GaAlAs laser to irradiation on the palatal donor site for photobiomodulation
Other Names:
  • Low level GaAlAs laser

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
Remaining wound area analyzed through photographs
Time Frame: 3 months
The defect area was measured after 90 post-operative days. For this, standardized photographs were taken (in terms of brightness, distance, and angle). A scale was used as a reference to measure the area. These photographs were exported to image software (Image J-NIH, Bethesda, USA), and the wound area was measured in square millimeters (mm²)
3 months

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
Tissue colorimetric evaluation analyzed through photographs
Time Frame: 3 months
Tissue color similarity between the region adjacent to the operated area and the post-operative image were analyzed through photographs. The photographs were exported to image software (Adobe Photoshop 3, München, Germany), and two areas were used: one from the wound and another adjacent area. The areas were measured through the Adobe Photoshop red-green chroma scale and the yellow-blue chroma scale and the results were presented in Bit/Pixels for both scales.
3 months
Presence or absence of scars or keloids
Time Frame: 3 months
The scar area was measured after 90 post-operative days. For this, standardized photographs were taken (in terms of brightness, distance, and angle). A scale was used as a reference to measure the keloid area. These photographs were exported to image software (Image J-NIH, Bethesda, USA), and the scar extension was measured in square millimeters (mm²)
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tissue brightness evaluation
Time Frame: 3 months
The areas were compared using brightness parameters. The photographs were exported to image software (Adobe Photoshop 3, München, Germany), and two areas were used: one from the wound and another adjacent area. The areas were measured through the Adobe Photoshop, and the results were expressed in a scale from 0 (black) to 255 (white) units of brightness.
3 months

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.
Universidade Estadual Paulista Júlio de Mesquita Filho

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.
  • Principal Investigator: Mauro P Santamaria, PhD, ICT-UNESP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
November 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.
October 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.
February 1, 2018

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 6, 2016

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.
December 17, 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.
December 22, 2016

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.
December 27, 2021

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.
December 23, 2021

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.
December 1, 2021

More Information

Terms related to this study

Keywords

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.
  • UEPJMF 6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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