Photobiomodulation of Palatal Donor Site After Free Gingival Graft Removal
Comparison of Two Energy Densities for Photobiomodulation of Palatal Donor Site After Free Gingival Graft Removal. Randomized Clinical Trial
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 6, 2016
CompletedFirst Posted
Study publicly available on registry
December 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedDecember 27, 2021
December 1, 2021
11 months
December 6, 2016
December 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remaining wound area analyzed through photographs
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 Outcomes (2)
Tissue colorimetric evaluation analyzed through photographs
3 months
Presence or absence of scars or keloids
3 months
Other Outcomes (1)
Tissue brightness evaluation
3 months
Study Arms (3)
Free gingival graft + PBM Sham
SHAM COMPARATORThe 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.
Free gingival graft + GaAlAs Laser 60
EXPERIMENTALThe 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.
Free gingival graft + GaAlAs Laser 15
EXPERIMENTALThe 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.
Interventions
Free gingival graft removal from palate for socket preservation
Utilization of GaAlAs laser to irradiation on the palatal donor site for photobiomodulation
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Felipe Lucas da Silva Neves
São José dos Campos, São Paulo, 12243-700, Brazil
Related Publications (3)
da Silva Neves FL, Silveira CA, Dias SB, Santamaria Junior 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.
PMID: 27344670BACKGROUNDWagner 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.
PMID: 24337496BACKGROUNDOzcelik 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.
PMID: 26660000BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mauro P Santamaria, PhD
ICT-UNESP
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 6, 2016
First Posted
December 22, 2016
Study Start
November 1, 2016
Primary Completion
October 1, 2017
Study Completion
February 1, 2018
Last Updated
December 27, 2021
Record last verified: 2021-12