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

Primary Purpose

Palatal Wound

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low Level Laser Therapy
GaAlAs laser
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Palatal Wound focused on measuring Connective tissue graft, Gingival recession, Low level laser therapy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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).

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Sham Comparator

    Experimental

    Experimental

    Arm Label

    Low Level Laser therapy (LLLT) Sham

    GaAlAs Laser therapy (LLLT) 60 J/cm²

    GaAlAs Laser therapy (LLLT) 30 J/cm²

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Postoperative Discomfort
    After air jet application, patients were requested to score postoperative discomfort through on a visual analogue scale (VAS) of 10 centimeters, in which 0 meant "no pain" and 10 meant "extreme pain". After this, a postoperative discomfort average for all groups was obtained.

    Full Information

    First Posted
    October 9, 2015
    Last Updated
    March 27, 2017
    Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02580357
    Brief Title
    Comparison of Two Different Low-level Laser Intensity Protocols on the Healing of Palatal Wounds
    Official Title
    Comparison of Two Different Low-level Laser Intensity Protocols on the Healing of Palatal Wounds After Connective Tissue Graft Removal: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    This is a prospective, parallel and controlled clinical trial. The population evaluated in the study was selected at Science and Technology Institute - ICT- São José dos Campos, College of Dentistry. Patients were assigned to one of the three treatment groups: Group 60 (Test, n=18): Periodontal surgery for root coverage through connective tissue graft and LLLT application on donor site using a 60 J/cm² dose. Group 30 (Test, n=18): Periodontal surgery for root coverage through connective tissue graft and LLLT application on donor site using a 30 J/cm² dose. Group Sham (Control, n= 18): Periodontal surgery for root coverage through connective tissue graft and LLLT SHAM on donor site. All surgeries were performed by the same expert periodontist (MPS). Before the surgical procedure, all patients were enlightened about the causes and consequences of gingival recession and prevention techniques. Factors related to the origin of gingival recession, such as toothbrush trauma and inflammation caused by biofilm, were controlled through instruction on standardized brushing technique to avoid the influence of other hygiene methods capable of promoting trauma on soft tissues. Standardized dental floss and toothbrushes were given to patients. The surgical technique adopted in the recession defects was the trapezoidal-type of CAF and the connective tissue graft was removed from palate mucosa . Briefly, a first incision on the palate was performed perpendicularly to the long axis of the teeth, 2 to 3 mm apical to the gingival margin. The mesial-distal length of the incision was determined by the length of the graft required to cover the recession. Because the selected recessions were in maxillary canines and premolars, the lengths of the graft varied minimally (10-12mm). The second incision was made parallel to the first one (1-2 mm apically and parallel to the long axis of the teeth) to separate the subepithelium connective tissue from the epithelial layer. The incision is carried far enough apically to provide a 7- mm height of connective tissue to cover the denuded root surface. Afterward, another incision parallel to the long axis of the teeth starting from the first incision was performed to separate the subepithelium connective tissue from the periosteum. Then, the connective tissue graft was removed from the palate as atraumatically as possible. Single sutures were made on the palate (4-0 silk) and the graft was sutured on the receptor site. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Palatal Wound
    Keywords
    Connective tissue graft, Gingival recession, Low level laser therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low Level Laser therapy (LLLT) Sham
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Arm Title
    GaAlAs Laser therapy (LLLT) 60 J/cm²
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    GaAlAs Laser therapy (LLLT) 30 J/cm²
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Low Level Laser Therapy
    Other Intervention Name(s)
    Laser stimulation
    Intervention Description
    Low Level Laser Therapy on the palatal donor site of connective tissue graft.
    Intervention Type
    Device
    Intervention Name(s)
    GaAlAs laser
    Other Intervention Name(s)
    Low level GaAlAs laser
    Intervention Description
    Utilization of GaAlAs laser to irradiation on the palatal donor site.
    Primary Outcome Measure Information:
    Title
    Change in the Remaining Wound Area (RWA)
    Description
    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).
    Time Frame
    7,14, 45 and 60 post operative days
    Secondary Outcome Measure Information:
    Title
    Postoperative Discomfort
    Description
    After air jet application, patients were requested to score postoperative discomfort through on a visual analogue scale (VAS) of 10 centimeters, in which 0 meant "no pain" and 10 meant "extreme pain". After this, a postoperative discomfort average for all groups was obtained.
    Time Frame
    7, 14, 45, and 60 days after surgical procedure
    Other Pre-specified Outcome Measures:
    Title
    Tissue Thickness
    Description
    Through four fixed points marked 5 and 7 mm from the gingival margin in the operated region, tissue thickness of palatine masticatory mucosa. One stent was made to standardize the points to be measured. The stent was positioned, and with a periodontal probe and the points were marked. Then the stent was removed and measurements were taken. For this, an endodontic spacer with a rubber cursor was put on the marked points for it to reach the palatine bone plate. Then the cursor was taken to the tissue carefully to not pressuring it. The distance between the spacer tip and the cursor was measured using a digital pachymeter and measured in millimeters (mm).
    Time Frame
    Before the procedure and 3 months after the procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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). 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mauro P Santamaria, PhD
    Organizational Affiliation
    College of Dentistry - São José dos Campos, State University of São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    14710766
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    7928129
    Citation
    Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.
    Results Reference
    background
    PubMed Identifier
    27344670
    Citation
    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.
    Results Reference
    derived

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

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