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Completed

NCT Number: NCT02896283

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

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.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Neda Moslemi

Tehran, Tehran Province, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-Level Laser Therapy

Radiation

Low-level laser therapy with the following parameters: Wavelength:660 nanometer, power: 200 mW, continuous mode, tme of irradiation: 32 seconds

Other names: low-level laser

Turned-off laser

Radiation

Laser device is turned-off. All parameters are like experimental group, however the laser in turned-off.

Other names: Placebo

Primary outcomes

  1. degree of epithelialization

    Time frame: At day 7

    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

  2. degree of epithelialization

    Time frame: At day 14

    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

  3. degree of epithelialization

    Time frame: At day 21

    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 outcomes

  1. Visual analogue scale (VAS) pain score

    Time frame: at day 1

    ask from patient about numbers of tablet consumption,record VAS analysis

  2. Visual analogue scale (VAS) pain score

    Time frame: at day 2

    ask from patient about numbers of tablet consumption,record VAS analysis

  3. Visual analogue scale (VAS) pain score

    Time frame: at day 3

    ask from patient about numbers of tablet consumption,record VAS analysis

  4. Visual analogue scale (VAS) pain score

    Time frame: at day 4

    ask from patient about numbers of tablet consumption,record VAS analysis

  5. Visual analogue scale (VAS) pain score

    Time frame: at day 5

    ask from patient about numbers of tablet consumption,record VAS analysis

  6. Visual analogue scale (VAS) pain score

    Time frame: at day 6

    ask from patient about numbers of tablet consumption,record VAS analysis

  7. Visual analogue scale (VAS) pain score

    Time frame: at day 7

    ask from patient about numbers of tablet consumption,record VAS analysis

  8. Visual analogue scale (VAS) pain score

    Time frame: at day 14

    ask from patient about numbers of tablet consumption,record VAS analysis

  9. Clinical healing

    Time frame: at day 1

    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.

  10. Clinical healing

    Time frame: at day 2

    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.

  11. Clinical healing

    Time frame: at day 7

    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.

  12. Clinical healing

    Time frame: at day 14

    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.

  13. Clinical healing

    Time frame: at day 21

    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.

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 12, 2016
Registry last updated
Sep 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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