NCT02896283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2012

Completed
3.7 years until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

Enrollment Period

6 months

First QC Date

December 15, 2012

Last Update Submit

September 6, 2016

Conditions

Gingival Recession

Keywords

wound healinglow-level laser therapygingival recession

Outcome Measures

Primary Outcomes (3)

  • 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

    At day 7

  • 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

    At day 14

  • 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

    At day 21

Secondary Outcomes (13)

  • Visual analogue scale (VAS) pain score

    at day 1

  • Visual analogue scale (VAS) pain score

    at day 2

  • Visual analogue scale (VAS) pain score

    at day 3

  • Visual analogue scale (VAS) pain score

    at day 4

  • Visual analogue scale (VAS) pain score

    at day 5

  • +8 more secondary outcomes

Study Arms (2)

low-level laser therapy

EXPERIMENTAL

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

Radiation: Low-level laser therapy

Turned-off laser

PLACEBO COMPARATOR

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

Radiation: Turned-off laser

Interventions

Low-level laser therapyRADIATION

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

Also known as: low-level laser
low-level laser therapy
Turned-off laserRADIATION

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

Also known as: Placebo
Turned-off laser

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • lack of keratinized tissue around teeth (bilateral)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neda Moslemi

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Neda Moslemi

    Laser Research Center of Dentistry, Tehran University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 15, 2012

First Posted

September 12, 2016

Study Start

February 1, 2012

Primary Completion

August 1, 2012

Study Completion

November 1, 2012

Last Updated

September 12, 2016

Record last verified: 2016-09

Locations

IR(1)