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Completed

NCT Number: NCT03000426

Photobiomodulation of Palatal Donor Site After Free Gingival Graft Removal

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.

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Key information

Conditions

Palatal Wound

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Felipe Lucas da Silva Neves

São José dos Campos, São Paulo, 12243-700, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Free gingival graft

Procedure

Free gingival graft removal from palate for socket preservation

Other names: Socket preservation

GaAlAs laser

Device

Utilization of GaAlAs laser to irradiation on the palatal donor site for photobiomodulation

Other names: Low level GaAlAs laser

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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)

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 22, 2016
Registry last updated
Dec 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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