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Effect of Low-Level Laser on Pain and Healing of Donor Site Following Free Gingival Graft

Primary Purpose

Gingival Recession

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Low-level laser therapy
Turned-off laser
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring wound healing, low-level laser therapy, gingival recession

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • lack of keratinized tissue around teeth (bilateral)

Exclusion Criteria:

  • patients with systemic diseases
  • non-cooperative patients
  • smokers
  • poor oral hygiene
  • root surface restorations or active caries

Sites / Locations

  • Neda Moslemi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

low-level laser therapy

Turned-off laser

Arm Description

Low-level laser (Diode, 66o nanometer, power:200 milli Watt (mW), Continuous wave, time of irradiation:32 seconds)is irradiated in donor site

The same protocol is applied in te donor site, unless the laser is remained off.

Outcomes

Primary Outcome Measures

degree of epithelialization
3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling Complete epithelialization: bubble was not seen Partial epithelialization: bubbles were seen in lesser than half of donor site No epithelialization: bubble were seen in more than half of donor site
degree of epithelialization
3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling Complete epithelialization: bubble was not seen Partial epithelialization: bubbles were seen in lesser than half of donor site No epithelialization: bubble were seen in more than half of donor site
degree of epithelialization
3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling Complete epithelialization: bubble was not seen Partial epithelialization: bubbles were seen in lesser than half of donor site No epithelialization: bubble were seen in more than half of donor site

Secondary Outcome Measures

Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Clinical healing
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
Clinical healing
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
Clinical healing
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
Clinical healing
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
Clinical healing
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.

Full Information

First Posted
December 15, 2012
Last Updated
September 6, 2016
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02896283
Brief Title
Effect of Low-Level Laser on Pain and Healing of Donor Site Following Free Gingival Graft
Official Title
The Effect of Low-Level Laser Therapy on Patient's Pain and Healing of Palatal Donor Site Following Free Gingival Graft: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this randomized split-mouth design clinical trial is to clinically evaluate the effectiveness of diode laser in the healing of donor site of palate in free gingival graft.
Detailed Description
Free gingival graft is the most predictable and successful method for increasing the width of keratinized tissue around teeth/dental implants and vestibular deepening. However, patient discomfort during the healing time is a major disadvantage of this procedure. Several methods have been introduced to accelerate the healing time and reduction of patient's pain during first days after surgery. Low-level lasers have shown promising results in biostimulation of cell growth and differentiation in cultures. However, there are lack of well designed double blind placebo controlled randomized controlled clinical studies evaluating the effects of Low-level laser therapy in acceleration of wound healing and pain relief of patients undergoing free gingival grafts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
wound healing, low-level laser therapy, gingival recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low-level laser therapy
Arm Type
Experimental
Arm Description
Low-level laser (Diode, 66o nanometer, power:200 milli Watt (mW), Continuous wave, time of irradiation:32 seconds)is irradiated in donor site
Arm Title
Turned-off laser
Arm Type
Placebo Comparator
Arm Description
The same protocol is applied in te donor site, unless the laser is remained off.
Intervention Type
Radiation
Intervention Name(s)
Low-level laser therapy
Other Intervention Name(s)
low-level laser
Intervention Description
Low-level laser therapy with the following parameters: Wavelength:660 nanometer, power: 200 mW, continuous mode, tme of irradiation: 32 seconds
Intervention Type
Radiation
Intervention Name(s)
Turned-off laser
Other Intervention Name(s)
Placebo
Intervention Description
Laser device is turned-off. All parameters are like experimental group, however the laser in turned-off.
Primary Outcome Measure Information:
Title
degree of epithelialization
Description
3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling Complete epithelialization: bubble was not seen Partial epithelialization: bubbles were seen in lesser than half of donor site No epithelialization: bubble were seen in more than half of donor site
Time Frame
At day 7
Title
degree of epithelialization
Description
3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling Complete epithelialization: bubble was not seen Partial epithelialization: bubbles were seen in lesser than half of donor site No epithelialization: bubble were seen in more than half of donor site
Time Frame
At day 14
Title
degree of epithelialization
Description
3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling Complete epithelialization: bubble was not seen Partial epithelialization: bubbles were seen in lesser than half of donor site No epithelialization: bubble were seen in more than half of donor site
Time Frame
At day 21
Secondary Outcome Measure Information:
Title
Visual analogue scale (VAS) pain score
Description
ask from patient about numbers of tablet consumption,record VAS analysis
Time Frame
at day 1
Title
Visual analogue scale (VAS) pain score
Description
ask from patient about numbers of tablet consumption,record VAS analysis
Time Frame
at day 2
Title
Visual analogue scale (VAS) pain score
Description
ask from patient about numbers of tablet consumption,record VAS analysis
Time Frame
at day 3
Title
Visual analogue scale (VAS) pain score
Description
ask from patient about numbers of tablet consumption,record VAS analysis
Time Frame
at day 4
Title
Visual analogue scale (VAS) pain score
Description
ask from patient about numbers of tablet consumption,record VAS analysis
Time Frame
at day 5
Title
Visual analogue scale (VAS) pain score
Description
ask from patient about numbers of tablet consumption,record VAS analysis
Time Frame
at day 6
Title
Visual analogue scale (VAS) pain score
Description
ask from patient about numbers of tablet consumption,record VAS analysis
Time Frame
at day 7
Title
Visual analogue scale (VAS) pain score
Description
ask from patient about numbers of tablet consumption,record VAS analysis
Time Frame
at day 14
Title
Clinical healing
Description
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
Time Frame
at day 1
Title
Clinical healing
Description
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
Time Frame
at day 2
Title
Clinical healing
Description
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
Time Frame
at day 7
Title
Clinical healing
Description
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
Time Frame
at day 14
Title
Clinical healing
Description
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
Time Frame
at day 21

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: lack of keratinized tissue around teeth (bilateral) Exclusion Criteria: patients with systemic diseases non-cooperative patients smokers poor oral hygiene root surface restorations or active caries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neda Moslemi
Organizational Affiliation
Laser Research Center of Dentistry, Tehran University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Neda Moslemi
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Effect of Low-Level Laser on Pain and Healing of Donor Site Following Free Gingival Graft

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