Palatal WoundPhase 4LLLTNCT02239042
Effect of Low-level Laser Therapy on Palatal Wound Healing
A Phase 4 study testing LLLT in people with Palatal Wound, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
The aim of the present study was to evaluate the influence of LLLT on the recovery of the palatine donor site wounds after harvest connective tissue graft. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Palatal Wound
- What is being tested?
- LLLT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to Jun 2013
- Phase
- Phase 4
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients that were 20 to 70 years old, both genders; presenting gingival recession Class I or II Miller, on vital canines or pre-molars, palatine region (donor site) with no pathological or morphological alterations; patients who agreed with and signed the formal consent to participate in the study, after receiving an explanation of risks and benefits, by an individual who was not a member of the present study (Resolution no. 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO 179/93).
Who cannot join
- Patients with systemic problems that contraindicated surgical procedure; patients under medication that would interfere with the wound healing; patients who smoked; patients who were pregnant or lactating; patients who had had periodontal surgery on the study area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Gallium-Aluminum-Arsenide Laser - AsGaAl Low-level Laser Therapy on the Healing of Human Palate Mucosa After Connective Tissue Graft Harvesting: Randomized Clinical Trial
The aim of the present study was to evaluate the influence of LLLT on the recovery of the palatine donor site wounds after harvest connective tissue graft.
Read the detailed description
This was a prospective, parallel and controlled clinical trial. The population evaluated in this study was selected at Science and Technology Institute - ICT - São José dos Campos, College of Dentistry
The selected patients were randomly allocated (by a computer generated list) into:
- Group 1 (Test, n=16): Periodontal surgery for root coverage through connective tissue graft and LLLT on donor site.
- Group 2 (Control, n=16): Periodontal surgery for root coverage through connective tissue graft and LLLT SHAM on donor site.
Surgical procedure was performed by one surgeon. The gingival recession defects were treated by connective tissue graft technique. A connective tissue graft was removed from palate mucosa following Bruno technique. Briefly, a first incision on the palate was performed perpendicularly to the long axis of the teeth, 2 to 3 mm apical to the gingival margin. The mesiodistal length of the incision was determined by the length of the graft required to cover the recession. Since the selected recessions were in maxillary canines and premolars, the length of the graft vary minimally (10-12mm). The second incision was made parallel to the first one, 1-2mm apically, and parallel to the long axis of the teeth in order to separate the subepithelium connective tissue from the epithelial layer. The incision is carried far enough apically to provide a 7mm height of connective tissue to cover the denuded root surface. Afterwards, another incision parallel to the long axis of the teeth, starting from the first incision was performed to separate the subepithelium connective tissue from the periosteum. Then, the connective tissue graft was removed from the palate as atraumatically as possible. Single sutures were made on the palate (4-0 silk) and the graft was sutured on the receptor site
Clinical parameters were assessed at baseline and 7, 14, 45, 60 and 90 days post-operatively
Statistical Analysis The null hypothesis considered in the study was the absence of difference in the clinical parameters between the different groups. For data analysis, the statistical program was used. The demographic and clinical data were compared between the groups using Student's t-test. The data were first analyzed for homogeneity using the Shapiro-Wilk test, which indicated non-normal distribution. . Those presenting Shapiro-Wilk p values < 0.05 were analyzed using a Friedman test (for intragroup comparisons) and Mann-Whitney tests (for intergroup comparisons). For remaining wound area, tissue colorimetry, tissue thickness, and post-operative discomfort parameter analysis, Two Way Repeated Measures ANOVA was performed for intra and intergroup analysis. T-test was used for intergroup comparison of number of analgesics taken. Presence or absence of scar was measured by Q-square test. For all tests significance level of 5% was used.
- Conditions
- Palatal Wound
- Being tested
- LLLT
- Keywords
- Gingival recessions
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLLTProcedure or surgery
Also called Low-level laser therapy (LLLT) after Coronally advanced falp and connective tissue graft technique to treat gingival recessions on the donor site
The patients allocated for the test group received the following protocol for laser application: Five (5) points of irradiation were performed. The irradiation was performed with a ASGaAl diode laser that continuously emitted a wavelength of 660 nm. 30 mW was used for 20 seconds, and the total applied energy density (fluence) was 15 J/cm2 (3 J/cm2 per point and an application time of 4 seconds per point). The applications were performed using punctual contact (to reduce reflection) with the tip perpendicular to the gingival tissue. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was followed by seven more applications performed every other day, with a total of 8 laser applications. The power of the equipment was calibrated prior to each application. The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue
| Study group | Role | What they receive |
|---|---|---|
| Low-level laser therapy (LLLT) Sham | Sham comparator | LLLT Sham on the palatal donor site of connective tissue graft Receives: Procedure: LLLT |
| Low-level laser therapy (LLLT) | Experimental | LLLT on the palatal donor site of connective tissue graft Receives: Procedure: LLLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Remaining wound area (RWA)
For this, standardized photographs were taken (brightness, distance and angle). A scale was used as a reference to measure this area. Theses photographs were exported to image software (Image J - NIH, Bethesda, USA) and the wound area was measured in square millimeters
Measured: 7, 14, 45 and 60 post-operative days
Secondary outcomes (1)
Post-operative discomfort
After air spray application, patients were required to fill a visual analogue scale (VAS), of 100mm, where the scale extremes were "no pain" to "extreme" to report measurement discomfort.
Measured: 7, 14, 45 and 60 days after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palatal WoundStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Pedrine Santamaria, UPECLIN HC FM Botucatu Unesp
- Investigators
- Mauro Santamaria, DDS, Ms, PhD, Principal investigator, FOSJC-UNESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239042
- Sponsor's protocol ID
- 132.831
- Acronym
- LLLT
- Status last verified
- Sep 2014
- First submitted
- 2 Sep 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dias SB, Fonseca MV, Dos Santos NC, Mathias IF, Martinho FC, Junior MS, Jardini MA, Santamaria MP. Effect of GaAIAs low-level laser therapy on the healing of human palate mucosa after connective tissue graft harvesting: randomized clinical trial. Lasers Med Sci. 2015 Aug;30(6):1695-702. doi: 10.1007/s10103-014-1685-2. Epub 2014 Nov 6.
PubMed 25373688
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gallium-Aluminum-Arsenide Laser - AsGaAl Low-level Laser Therapy on the Healing of Human Palate Mucosa After Connective Tissue Graft Harvesting: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02239042
- Acronym / sponsor ID
- LLLT / 132.831
- Conditions
- Palatal Wound
- Keywords
- Gingival recessions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Sep 2014 (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 the present study was to evaluate the influence of LLLT on the recovery of the palatine donor site wounds after harvest connective tissue graft.
Detailed description
This was a prospective, parallel and controlled clinical trial. The population evaluated in this study was selected at Science and Technology Institute - ICT - São José dos Campos, College of Dentistry
The selected patients were randomly allocated (by a computer generated list) into:
- Group 1 (Test, n=16): Periodontal surgery for root coverage through connective tissue graft and LLLT on donor site.
- Group 2 (Control, n=16): Periodontal surgery for root coverage through connective tissue graft and LLLT SHAM on donor site.
Surgical procedure was performed by one surgeon. The gingival recession defects were treated by connective tissue graft technique. A connective tissue graft was removed from palate mucosa following Bruno technique. Briefly, a first incision on the palate was performed perpendicularly to the long axis of the teeth, 2 to 3 mm apical to the gingival margin. The mesiodistal length of the incision was determined by the length of the graft required to cover the recession. Since the selected recessions were in maxillary canines and premolars, the length of the graft vary minimally (10-12mm). The second incision was made parallel to the first one, 1-2mm apically, and parallel to the long axis of the teeth in order to separate the subepithelium connective tissue from the epithelial layer. The incision is carried far enough apically to provide a 7mm height of connective tissue to cover the denuded root surface. Afterwards, another incision parallel to the long axis of the teeth, starting from the first incision was performed to separate the subepithelium connective tissue from the periosteum. Then, the connective tissue graft was removed from the palate as atraumatically as possible. Single sutures were made on the palate (4-0 silk) and the graft was sutured on the receptor site
Clinical parameters were assessed at baseline and 7, 14, 45, 60 and 90 days post-operatively
Statistical Analysis The null hypothesis considered in the study was the absence of difference in the clinical parameters between the different groups. For data analysis, the statistical program was used. The demographic and clinical data were compared between the groups using Student's t-test. The data were first analyzed for homogeneity using the Shapiro-Wilk test, which indicated non-normal distribution. . Those presenting Shapiro-Wilk p values < 0.05 were analyzed using a Friedman test (for intragroup comparisons) and Mann-Whitney tests (for intergroup comparisons). For remaining wound area, tissue colorimetry, tissue thickness, and post-operative discomfort parameter analysis, Two Way Repeated Measures ANOVA was performed for intra and intergroup analysis. T-test was used for intergroup comparison of number of analgesics taken. Presence or absence of scar was measured by Q-square test. For all tests significance level of 5% was used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-level laser therapy (LLLT) Sham | Sham comparator | Procedure: LLLTLLLT Sham on the palatal donor site of connective tissue graft |
| Low-level laser therapy (LLLT) | Experimental | Procedure: LLLTLLLT on the palatal donor site of connective tissue graft |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that were 20 to 70 years old, both genders; presenting gingival recession Class I or II Miller, on vital canines or pre-molars, palatine region (donor site) with no pathological or morphological alterations; patients who agreed with and signed the formal consent to participate in the study, after receiving an explanation of risks and benefits, by an individual who was not a member of the present study (Resolution no. 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO 179/93).
Key exclusion criteria (1 listed)
- Patients with systemic problems that contraindicated surgical procedure; patients under medication that would interfere with the wound healing; patients who smoked; patients who were pregnant or lactating; patients who had had periodontal surgery on the study area.
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 |
|---|---|---|
| LLLTAlso: Low-level laser therapy (LLLT) after Coronally advanced falp and connective tissue graft technique to treat gingival recessions on the donor siteThe patients allocated for the test group received the following protocol for laser application: Five (5) points of irradiation were performed. The irradiation was performed with a ASGaAl diode laser that continuously emitted a wavelength of 660 nm. 30 mW was used for 20 seconds, and the total applied energy density (fluence) was 15 J/cm2 (3 J/cm2 per point and an application time of 4 seconds per point). The applications were performed using punctual contact (to reduce reflection) with the tip perpendicular to the gingival tissue. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was followed by seven more applications performed every other day, with a total of 8 laser applications. The power of the equipment was calibrated prior to each application. The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue | Procedure or surgery | Low-level laser therapy (LLLT), Low-level laser therapy (LLLT) Sham |
Primary outcome
Change in the Remaining wound area (RWA)
Time frame: 7, 14, 45 and 60 post-operative days
For this, standardized photographs were taken (brightness, distance and angle). A scale was used as a reference to measure this area. Theses photographs were exported to image software (Image J - NIH, Bethesda, USA) and the wound area was measured in square millimeters
1 secondary outcome
Post-operative discomfort
Time frame: 7, 14, 45 and 60 days after surgical procedure
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 2014.
- Derived from this study: PubMed 25373688Dias SB, Fonseca MV, Dos Santos NC, Mathias IF, Martinho FC, Junior MS, Jardini MA, Santamaria MP. Effect of GaAIAs low-level laser therapy on the healing of human palate mucosa after connective tissue graft harvesting: randomized clinical trial. Lasers Med Sci. 2015 Aug;30(6):1695-702. doi: 10.1007/s10103-014-1685-2. Epub 2014 Nov 6.
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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.
Mauro Santamaria, DDS, Ms, PhD principal investigator
FOSJC-UNESP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LLLT in people with Palatal Wound, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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 1 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 2014. 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 Brazil. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in the Remaining wound area (RWA) (time frame: 7, 14, 45 and 60 post-operative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02239042, which also lists 1 linked publication.
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 2014.