Wounds and InjuriesNCT03425695
Free Gingival Graft Adjunct With Low Level Laser Therapy
A study testing CheseeTM Diode Laser and Clinical examination in people with Wounds and Injuries and Transplants, run by Abant Izzet Baysal University.
Trial summary
The present placebo-controlled parallel design clinical study was planned to determine the effect of low level laser therapy on clinical periodontal conditions and dimensions of free gingival graft as well as postoperative pain levels in the surgical area. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds and Injuries, Transplants, Gingival Recession, Localized
- What is being tested?
- CheseeTM Diode Laser and Clinical examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Sep 2017
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients >18 years old
- Patients presenting Class I or II Miller gingival recession on vital incisors in the mandibular anterior region with no caries or restoration
- The included teeth had also keratinized gingiva <2 mm; PI and GI<1.
- The patients had to be systemically healthy and non-smokers.
Who cannot join
- Patients presenting active periodontal disease and probing depth >3 mm; taking medications that would interfere with the wound-healing process or that contraindicate the surgical procedure;
- Pregnant or lactating women;
- Patients who underwent periodontal surgery in the study area;
- Patients with orthodontic therapy in progress were excluded.
About this study
Official title: Free Gingival Graft Adjunct With Low Level Laser Therapy: A Randomized Placebo- Controlled Parallel Group Study
The present placebo-controlled parallel design clinical study was planned to determine the effect of low level laser therapy on clinical periodontal conditions and dimensions of free gingival graft as well as postoperative pain levels in the surgical area.
Read the detailed description
Background: Shrinkage of the free gingival graft (FGG) and patient's discomfort during healing period are important concerns. Therefore, this study aimed to evaluate the effect of low level laser therapy (LLLT) in terms of enhancing wound healing, reducing graft shrinkage and postoperative pain.
Methods: Thirty patients were randomly assigned to receive either FGG+ LLLT (test, n = 15) or FGG + placebo LLLT (control, n = 15). In the test group, a diode laser (aluminum-gallium-arsenide, 810 nm, 0.1 W, continuous mode, time of irradiation:60 s, energy density: 6 J/cm2, spot size:0.5 cm) was applied immediately after the FGG surgery and 1,3,7, and 14 days later. The control group received the same sequence of irradiation with the laser-off. Comparison of the graft surface areas between groups at 1st, 3rd and 6th months were made with an image-analyzing software. Complete wound epithelization, visual analogue scale (VAS) pain score of recipient site and the number of analgesic used were evaluated after the surgery.
- Being tested
- CheseeTM Diode Laser, Clinical examination
- Keywords
- Free gingival graft, Low level laser therapy, Shrinkage
- Medical subject headings
- Wounds and Injuries, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CheseeTM Diode LaserDevice
low level laser therapy was utilized adjunct with free gingival graft.
Clinical examinationOther
The shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd, and 6th months.
Epithelization was determined via bubbling test by using 3% hydrogen peroxide (H2O2) at 7, 14, 21, and 28 days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Free Gingival Graft (FGG) + Low Level Laser Therapy (LLLT) + Clinical Examination
The test group received LLLT with a diode laser (CheseeTM Diode Laser, Wuhan, China ) at the FGG sites with a wavelength of 810 nm and output power of 0.1 W, for 60 s, with an energy density of 6 J/cm2 in the continuous wave mode (spot size:0.5 cm). The laser beam was directed perpendicularly toward the tissue in the noncontact mode. The laser was irradiated at the recipient sites immediately after surgery and 1, 3, 7, and 14 days later. Receives: Device: CheseeTM Diode Laser; Other: Clinical examination |
| Control group | Placebo comparator | Free Gingival Graft (FGG)+Placebo Low Level Laser Therapy (PLLLT) + Clinical Examination
The control group received PLLLT with a diode laser (CheseeTM Diode Laser, Wuhan, China ) same as test group without pushing the start button Receives: Device: CheseeTM Diode Laser; Other: Clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft shrinkage
The shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd, and 6th months.
Measured: 1-, 3-, and 6-months after FGG surgery
Secondary outcomes (1)
Epithelization
Epithelization was determined via bubbling test by using 3% hydrogen peroxide (H2O2). This test was carried out at 7, 14, 21, and 28 days after surgery.
Measured: 7, 14, 21, and 28 days after FGG surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study startJun 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo-controlled parallel design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadiye Gunpinar, Abant Izzet Baysal University
- Investigators
- AIBU Faculty of Dentistry, Study chair, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425695
- Sponsor's protocol ID
- AIBU
- Status last verified
- Jan 2018
- First submitted
- 26 Jan 2018
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Gingival Graft Adjunct With Low Level Laser Therapy: A Randomized Placebo- Controlled Parallel Group Study
- ClinicalTrials.gov ID
- NCT03425695
- Acronym / sponsor ID
- AIBU
- Keywords
- Free gingival graft, Low level laser therapy, Shrinkage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Feb 2018 (actual)
- 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 present placebo-controlled parallel design clinical study was planned to determine the effect of low level laser therapy on clinical periodontal conditions and dimensions of free gingival graft as well as postoperative pain levels in the surgical area.
Detailed description
Background: Shrinkage of the free gingival graft (FGG) and patient's discomfort during healing period are important concerns. Therefore, this study aimed to evaluate the effect of low level laser therapy (LLLT) in terms of enhancing wound healing, reducing graft shrinkage and postoperative pain.
Methods: Thirty patients were randomly assigned to receive either FGG+ LLLT (test, n = 15) or FGG + placebo LLLT (control, n = 15). In the test group, a diode laser (aluminum-gallium-arsenide, 810 nm, 0.1 W, continuous mode, time of irradiation:60 s, energy density: 6 J/cm2, spot size:0.5 cm) was applied immediately after the FGG surgery and 1,3,7, and 14 days later. The control group received the same sequence of irradiation with the laser-off. Comparison of the graft surface areas between groups at 1st, 3rd and 6th months were made with an image-analyzing software. Complete wound epithelization, visual analogue scale (VAS) pain score of recipient site and the number of analgesic used were evaluated after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled parallel design
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: CheseeTM Diode Laser, Other: Clinical examinationFree Gingival Graft (FGG) + Low Level Laser Therapy (LLLT) + Clinical Examination The test group received LLLT with a diode laser (CheseeTM Diode Laser, Wuhan, China ) at the FGG sites with a wavelength of 810 nm and output power of 0.1 W, for 60 s, with an energy density of 6 J/cm2 in the continuous wave mode (spot size:0.5 cm). The laser beam was directed perpendicularly toward the tissue in the noncontact mode. The laser was irradiated at the recipient sites immediately after surgery and 1, 3, 7, and 14 days later. |
| Control group | Placebo comparator | Device: CheseeTM Diode Laser, Other: Clinical examinationFree Gingival Graft (FGG)+Placebo Low Level Laser Therapy (PLLLT) + Clinical Examination The control group received PLLLT with a diode laser (CheseeTM Diode Laser, Wuhan, China ) same as test group without pushing the start button |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients >18 years old
- Patients presenting Class I or II Miller gingival recession on vital incisors in the mandibular anterior region with no caries or restoration
- The included teeth had also keratinized gingiva <2 mm; PI and GI<1.
- The patients had to be systemically healthy and non-smokers.
Key exclusion criteria (4 listed)
- Patients presenting active periodontal disease and probing depth >3 mm; taking medications that would interfere with the wound-healing process or that contraindicate the surgical procedure;
- Pregnant or lactating women;
- Patients who underwent periodontal surgery in the study area;
- Patients with orthodontic therapy in progress were excluded.
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 |
|---|---|---|
| CheseeTM Diode Laserlow level laser therapy was utilized adjunct with free gingival graft. | Device | Control group, Test group |
| Clinical examinationThe shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd, and 6th months. Epithelization was determined via bubbling test by using 3% hydrogen peroxide (H2O2) at 7, 14, 21, and 28 days after surgery. | Other | Control group, Test group |
Primary outcome
Graft shrinkage
Time frame: 1-, 3-, and 6-months after FGG surgery
The shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd, and 6th months.
1 secondary outcome
Epithelization
Time frame: 7, 14, 21, and 28 days after FGG surgery
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 8 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
AIBU Faculty of Dentistry study chair
Abant Izzet Baysal University
Questions about this trial
What is this clinical trial studying?
A study testing CheseeTM Diode Laser and Clinical examination in people with Wounds and Injuries and Transplants, run by Abant Izzet Baysal University.
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 4 inclusion and 4 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 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Graft shrinkage (time frame: 1-, 3-, and 6-months after FGG surgery). 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 8 Feb 2018.