Gingival RecessionPhase 2/3NCT02896283
Effect of Low-Level Laser on Pain and Healing of Donor Site Following Free Gingival Graft
A Phase 2/3 study testing Low-level laser therapy and Turned-off laser in people with Gingival Recession, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Low-level laser therapy and Turned-off laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteIran
- Study dates
- Feb 2012to Nov 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- lack of keratinized tissue around teeth (bilateral)
Who cannot join
- patients with systemic diseases
- non-cooperative patients
- smokers
- poor oral hygiene
- root surface restorations or active caries
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Gingival Recession
- Being tested
- Low-level laser therapy, Turned-off laser
- Keywords
- wound healing, low-level laser therapy, gingival recession
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapyRadiation
Also called low-level laser
Low-level laser therapy with the following parameters: Wavelength:660 nanometer, power: 200 mW, continuous mode, tme of irradiation: 32 seconds
Turned-off laserRadiation
Also called Placebo
Laser device is turned-off. All parameters are like experimental group, however the laser in turned-off.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Radiation: Turned-off laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: At day 21
Secondary outcomes (13)
Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Measured: at day 1
Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Measured: at day 2
Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Measured: at day 3
Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Measured: at day 4
Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Measured: at day 5
Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Measured: at day 6
Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Measured: at day 7
Visual analogue scale (VAS) pain score
ask from patient about numbers of tablet consumption,record VAS analysis
Measured: at day 14
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.
Measured: at day 1
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.
Measured: at day 2
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.
Measured: at day 7
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.
Measured: at day 14
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.
Measured: at day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neda Moslemi, Tehran University of Medical Sciences
- Investigators
- Neda Moslemi, Study director, Laser Research Center of Dentistry, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896283
- Sponsor's protocol ID
- 91-01-97-16886
- Status last verified
- Sep 2016
- First submitted
- 15 Dec 2012
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02896283
- Acronym / sponsor ID
- 91-01-97-16886
- Conditions
- Gingival Recession
- Keywords
- wound healing, low-level laser therapy, gingival recession
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-level laser therapy | Experimental | Radiation: Low-level laser therapyLow-level laser (Diode, 66o nanometer, power:200 milli Watt (mW), Continuous wave, time of irradiation:32 seconds)is irradiated in donor site |
| Turned-off laser | Placebo comparator | Radiation: Turned-off laserThe same protocol is applied in te donor site, unless the laser is remained off. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- lack of keratinized tissue around teeth (bilateral)
Key exclusion criteria (5 listed)
- patients with systemic diseases
- non-cooperative patients
- smokers
- poor oral hygiene
- root surface restorations or active caries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-level laser therapyAlso: low-level laserLow-level laser therapy with the following parameters: Wavelength:660 nanometer, power: 200 mW, continuous mode, tme of irradiation: 32 seconds | Radiation | low-level laser therapy |
| Turned-off laserAlso: PlaceboLaser device is turned-off. All parameters are like experimental group, however the laser in turned-off. | Radiation | Turned-off laser |
Primary outcome
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
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
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
13 secondary outcomes
Visual analogue scale (VAS) pain score
Time frame: at day 1
Visual analogue scale (VAS) pain score
Time frame: at day 2
Visual analogue scale (VAS) pain score
Time frame: at day 3
Visual analogue scale (VAS) pain score
Time frame: at day 4
Visual analogue scale (VAS) pain score
Time frame: at day 5
Visual analogue scale (VAS) pain score
Time frame: at day 6
Visual analogue scale (VAS) pain score
Time frame: at day 7
Visual analogue scale (VAS) pain score
Time frame: at day 14
Clinical healing
Time frame: at day 1
Clinical healing
Time frame: at day 2
Clinical healing
Time frame: at day 7
Clinical healing
Time frame: at day 14
Clinical healing
Time frame: at day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
Related trials for Gingival Recession
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Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Recruiting
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Gingival Graft, Recession, Gingival
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neda Moslemi study director
Laser Research Center of Dentistry, Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Low-level laser therapy and Turned-off laser in people with Gingival Recession, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of epithelialization (time frame: At day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2016.