Comparison of Two Different Low-level Laser Intensity Protocols on the Healing of Palatal Wounds

NCT02580357 | Completed Results

• 1 other identifier: UEPJMF 2
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to compare two intensities of LLLT on wound healing process of the donor palatine area after CTG removal.

Conditions

Palatal Wound

Keywords

Connective tissue graft; Gingival recession; Low level laser therapy

Outcome Measures

Primary Outcomes (1)

• Change in the Remaining Wound Area (RWA)

  For this, standardized photographs were taken (brightness, distance and angle). A scale was used as a reference to measure this area. These photographs were exported to image software ( Image J - NIH, Bethesda, USA) and remaining wound area was measured in square millimeters (mm²).

  7,14, 45 and 60 post operative days

Secondary Outcomes (1)

• Postoperative Discomfort

  7, 14, 45, and 60 days after surgical procedure

Other Outcomes (1)

• Tissue Thickness

  Before the procedure and 3 months after the procedure

Study Arms (3)

Low Level Laser therapy (LLLT) Sham

SHAM COMPARATOR

The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.

Procedure: Low Level Laser Therapy; Device: GaAlAs laser

GaAlAs Laser therapy (LLLT) 60 J/cm²

EXPERIMENTAL

The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.

Procedure: Low Level Laser Therapy; Device: GaAlAs laser

GaAlAs Laser therapy (LLLT) 30 J/cm²

EXPERIMENTAL

The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.

Procedure: Low Level Laser Therapy; Device: GaAlAs laser

Interventions

Low Level Laser Therapy PROCEDURE

Low Level Laser Therapy on the palatal donor site of connective tissue graft.

Also known as: Laser stimulation

GaAlAs Laser therapy (LLLT) 30 J/cm²; GaAlAs Laser therapy (LLLT) 60 J/cm²; Low Level Laser therapy (LLLT) Sham

GaAlAs laser DEVICE

Utilization of GaAlAs laser to irradiation on the palatal donor site.

Also known as: Low level GaAlAs laser

GaAlAs Laser therapy (LLLT) 30 J/cm²; GaAlAs Laser therapy (LLLT) 60 J/cm²; Low Level Laser therapy (LLLT) Sham

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were 20 to 70 years old and of both genders, presenting Class I or II Miller gingival recession on vital canines or premolars in the palatine region (donor site) with no pathological or morphological alterations.
• 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 - CFO 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.

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Related Publications (3)

• Zucchelli G, Amore C, Sforza NM, Montebugnoli L, De Sanctis M. Bilaminar techniques for the treatment of recession-type defects. A comparative clinical study. J Clin Periodontol. 2003 Oct;30(10):862-70. doi: 10.1034/j.1600-051x.2003.00397.x.

  PMID: 14710766 BACKGROUND

• Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.

  PMID: 7928129 BACKGROUND

• 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: 27344670 DERIVED

MeSH Terms

Conditions

Gingival Recession

Interventions

Low-Level Light Therapy; Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Dr. Mauro P. Santamaria
• Organization: Institute of Science and Technology of São José dos Campos (Unesp)

mauro.santamaria@ict.unesp.br

+55 (16) 981937777

Study Officials

• Mauro P Santamaria, PhD

  College of Dentistry - São José dos Campos, State University of São Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Professor

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: October 20, 2015
• Study Start: February 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 8, 2017
• Results First Posted: May 8, 2017

Record last verified: 2017-03