Photobiomodulation of Palatal Donor Site After Free Gingival Graft Removal

• ClinicalTrials.gov Identifier: NCT03000426
• Recruitment Status: Unknown
• First Posted: December 22, 2016
• Last Update Posted: December 22, 2016
• Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
• Information provided by (Responsible Party): Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Palatal Wound	Procedure: Free gingival graft; Device: GaAlAs laser	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Two Energy Densities for Photobiomodulation of Palatal Donor Site After Free Gingival Graft Removal. Randomized Clinical Trial
• Study Start Date: November 2016
• Estimated Primary Completion Date: October 2017
• Estimated Study Completion Date: February 2018

Arms and Interventions

Arm	Intervention/treatment
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 Name: Socket preservation; Device: GaAlAs laser; Utilization of GaAlAs laser to irradiation on the palatal donor site for photobiomodulation; Other Name: 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 Name: Socket preservation; Device: GaAlAs laser; Utilization of GaAlAs laser to irradiation on the palatal donor site for photobiomodulation; Other Name: 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 Name: Socket preservation; Device: GaAlAs laser; Utilization of GaAlAs laser to irradiation on the palatal donor site for photobiomodulation; Other Name: Low level GaAlAs laser

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Contact: Mauro P Santamaria, PhD; +55 (16) 981937777; mauro.santamaria@ict.unesp.br

Locations

Brazil

Felipe Lucas da Silva Neves; Recruiting

Sao Jose dos Campos, São Paulo, Brazil, 12243-700

Contact: Felipe L Neves, Ms 55 12 997993703 fe-lucas21@hotmail.com

Sponsors and Collaborators

Universidade Estadual Paulista Júlio de Mesquita Filho

Investigators

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

More Information

Publications:

da Silva Neves FL, Silveira CA, Dias SB, Santamaria Júnior M, de Marco AC, Kerbauy WD, de Melo Filho AB, Jardini MA, Santamaria MP. Comparison of two power densities on the healing of palatal wounds after connective tissue graft removal: randomized clinical trial. Lasers Med Sci. 2016 Sep;31(7):1371-8. doi: 10.1007/s10103-016-1988-6. Epub 2016 Jun 25.

Wagner VP, Meurer L, Martins MA, Danilevicz CK, Magnusson AS, Marques MM, Filho MS, Squarize CH, Martins MD. Influence of different energy densities of laser phototherapy on oral wound healing. J Biomed Opt. 2013 Dec;18(12):128002. doi: 10.1117/1.JBO.18.12.128002.

Ozcelik O, Seydaoglu G, Haytac CM. Diode laser for harvesting de-epithelialized palatal graft in the treatment of gingival recession defects: a randomized clinical trial. J Clin Periodontol. 2016 Jan;43(1):63-71. doi: 10.1111/jcpe.12487. Epub 2016 Jan 21.

• Responsible Party: Mauro Pedrine Santamaria, Assistant Professor, Universidade Estadual Paulista Júlio de Mesquita Filho
• ClinicalTrials.gov Identifier: NCT03000426
• Other Study ID Numbers: UEPJMF 6
• First Posted: December 22, 2016
• Last Update Posted: December 22, 2016
• Last Verified: December 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho:

Low level laser therapy