Palatal WoundNCT02580357
Comparison of Two Different Low-level Laser Intensity Protocols on the Healing of Palatal Wounds
A study testing Low Level Laser Therapy and GaAlAs laser in people with Palatal Wound, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
Trial summary
The aim of this study was to compare two intensities of LLLT on wound healing process of the donor palatine area after CTG removal. 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?
- Low Level Laser Therapy and GaAlAs laser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 were 20 to 70 years old and of both genders, presenting Class I or II Miller gingival recession on vital canines or premolars in the palatine region (donor site) with no pathological or morphological alterations.
- Patients agreed to and signed the formal consent to participate in the study after receiving an explanation of risks and benefits from 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
- Were excluded patients with systemic problems that contraindicated surgical procedure
- Those under medication that could interfere with the wound healing
- Those who smoked
- Those who were pregnant or lactating, and
- Those who had had periodontal surgery on the study area.
About this study
Official title: Comparison of Two Different Low-level Laser Intensity Protocols on the Healing of Palatal Wounds After Connective Tissue Graft Removal: Randomized Clinical Trial
The aim of this study was to compare two intensities of LLLT on wound healing process of the donor palatine area after CTG removal.
Read the detailed description
This is a prospective, parallel and controlled clinical trial. The population evaluated in the study was selected at Science and Technology Institute - ICT- São José dos Campos, College of Dentistry.
Patients were assigned to one of the three treatment groups:
- Group 60 (Test, n=18): Periodontal surgery for root coverage through connective tissue graft and LLLT application on donor site using a 60 J/cm² dose.
- Group 30 (Test, n=18): Periodontal surgery for root coverage through connective tissue graft and LLLT application on donor site using a 30 J/cm² dose.
- Group Sham (Control, n= 18): Periodontal surgery for root coverage through connective tissue graft and LLLT SHAM on donor site.
All surgeries were performed by the same expert periodontist (MPS). Before the surgical procedure, all patients were enlightened about the causes and consequences of gingival recession and prevention techniques. Factors related to the origin of gingival recession, such as toothbrush trauma and inflammation caused by biofilm, were controlled through instruction on standardized brushing technique to avoid the influence of other hygiene methods capable of promoting trauma on soft tissues. Standardized dental floss and toothbrushes were given to patients. The surgical technique adopted in the recession defects was the trapezoidal-type of CAF and the connective tissue graft was removed from palate mucosa . 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 mesial-distal length of the incision was determined by the length of the graft required to cover the recession. Because the selected recessions were in maxillary canines and premolars, the lengths of the graft varied minimally (10-12mm). The second incision was made parallel to the first one (1-2 mm apically and parallel to the long axis of the teeth) to separate the subepithelium connective tissue from the epithelial layer. The incision is carried far enough apically to provide a 7- mm height of connective tissue to cover the denuded root surface. Afterward, 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.
The evaluated parameters were wound remaining area (WRA), scar and tissue colorimetry (TC), tissue thickness (TT) and postoperative discomfort (D), evaluated at baseline and 7, 14, 45, 60, and 90 days after surgery.
Statistical Analysis: All data were expressed as mean ± standard deviation or expressed in percentages during the descriptive phase. Data were analyzed according to distribution by the Shapiro-Wilk test. For the remaining wound area, tissue colorimetry, tissue thickness, and postoperative discomfort parameter analysis, two way repeated measures ANOVA was performed for intra- and intergroup analysis. T test was used for intergroup comparison of the number of analgesics taken. The presence or absence of scars was measured by Q-square test. Statistical analysis was performed using Sigma Plot 12.0. In all tests a significance level of 0.05 was chosen.
- Conditions
- Palatal Wound
- Being tested
- Low Level Laser Therapy, GaAlAs laser
- Keywords
- Connective tissue graft, Gingival recession, Low level laser therapy
- 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 TherapyProcedure or surgery
Also called Laser stimulation
Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laserDevice
Also called Low level GaAlAs laser
Utilization of GaAlAs laser to irradiation on the palatal donor site.
| Study group | Role | What they receive |
|---|---|---|
| Low Level Laser therapy (LLLT) Sham | Sham comparator | 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. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. Receives: Procedure: Low Level Laser Therapy; Device: GaAlAs laser |
| GaAlAs Laser therapy (LLLT) 60 J/cm² | Experimental | The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application. Receives: Procedure: Low Level Laser Therapy; Device: GaAlAs laser |
| GaAlAs Laser therapy (LLLT) 30 J/cm² | Experimental | The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application. Receives: Procedure: Low Level Laser Therapy; Device: GaAlAs laser |
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. These photographs were exported to image software ( Image J - NIH, Bethesda, USA) and remaining wound area was measured in square millimeters (mm²).
Measured: 7,14, 45 and 60 post operative days
Secondary outcomes (1)
Postoperative Discomfort
After air jet application, patients were requested to score postoperative discomfort through on a visual analogue scale (VAS) of 10 centimeters, in which 0 meant "no pain" and 10 meant "extreme pain". After this, a postoperative discomfort average for all groups was obtained.
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 posted20 Oct 2015 (estimated)
- Study startFeb 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Mauro P Santamaria, PhD, Principal investigator, College of Dentistry - São José dos Campos, State University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580357
- Sponsor's protocol ID
- UEPJMF 2
- Status last verified
- Mar 2017
- First submitted
- 9 Oct 2015
- Last updated
- 8 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Zucchelli G, Amore C, Sforza NM, Montebugnoli L, De Sanctis M. Bilaminar techniques for the treatment of recession-type defects. A comparative clinical study. J Clin Periodontol. 2003 Oct;30(10):862-70. doi: 10.1034/j.1600-051x.2003.00397.x.
PubMed 14710766Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.
PubMed 7928129da Silva Neves FL, Silveira CA, Dias SB, Santamaria Junior M, de Marco AC, Kerbauy WD, de Melo Filho AB, Jardini MA, Santamaria MP. Comparison of two power densities on the healing of palatal wounds after connective tissue graft removal: randomized clinical trial. Lasers Med Sci. 2016 Sep;31(7):1371-8. doi: 10.1007/s10103-016-1988-6. Epub 2016 Jun 25.
PubMed 27344670
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Low-level Laser Intensity Protocols on the Healing of Palatal Wounds After Connective Tissue Graft Removal: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02580357
- Acronym / sponsor ID
- UEPJMF 2
- Conditions
- Palatal Wound
- Keywords
- Connective tissue graft, Gingival recession, Low level laser therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Posted 8 May 2017
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 study was to compare two intensities of LLLT on wound healing process of the donor palatine area after CTG removal.
Detailed description
This is a prospective, parallel and controlled clinical trial. The population evaluated in the study was selected at Science and Technology Institute - ICT- São José dos Campos, College of Dentistry.
Patients were assigned to one of the three treatment groups:
- Group 60 (Test, n=18): Periodontal surgery for root coverage through connective tissue graft and LLLT application on donor site using a 60 J/cm² dose.
- Group 30 (Test, n=18): Periodontal surgery for root coverage through connective tissue graft and LLLT application on donor site using a 30 J/cm² dose.
- Group Sham (Control, n= 18): Periodontal surgery for root coverage through connective tissue graft and LLLT SHAM on donor site.
All surgeries were performed by the same expert periodontist (MPS). Before the surgical procedure, all patients were enlightened about the causes and consequences of gingival recession and prevention techniques. Factors related to the origin of gingival recession, such as toothbrush trauma and inflammation caused by biofilm, were controlled through instruction on standardized brushing technique to avoid the influence of other hygiene methods capable of promoting trauma on soft tissues. Standardized dental floss and toothbrushes were given to patients. The surgical technique adopted in the recession defects was the trapezoidal-type of CAF and the connective tissue graft was removed from palate mucosa . 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 mesial-distal length of the incision was determined by the length of the graft required to cover the recession. Because the selected recessions were in maxillary canines and premolars, the lengths of the graft varied minimally (10-12mm). The second incision was made parallel to the first one (1-2 mm apically and parallel to the long axis of the teeth) to separate the subepithelium connective tissue from the epithelial layer. The incision is carried far enough apically to provide a 7- mm height of connective tissue to cover the denuded root surface. Afterward, 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.
The evaluated parameters were wound remaining area (WRA), scar and tissue colorimetry (TC), tissue thickness (TT) and postoperative discomfort (D), evaluated at baseline and 7, 14, 45, 60, and 90 days after surgery.
Statistical Analysis: All data were expressed as mean ± standard deviation or expressed in percentages during the descriptive phase. Data were analyzed according to distribution by the Shapiro-Wilk test. For the remaining wound area, tissue colorimetry, tissue thickness, and postoperative discomfort parameter analysis, two way repeated measures ANOVA was performed for intra- and intergroup analysis. T test was used for intergroup comparison of the number of analgesics taken. The presence or absence of scars was measured by Q-square test. Statistical analysis was performed using Sigma Plot 12.0. In all tests a significance level of 0.05 was chosen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Level Laser therapy (LLLT) Sham | Sham comparator | Procedure: Low Level Laser Therapy, Device: GaAlAs laserThe 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. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. |
| GaAlAs Laser therapy (LLLT) 60 J/cm² | Experimental | Procedure: Low Level Laser Therapy, Device: GaAlAs laserThe irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application. |
| GaAlAs Laser therapy (LLLT) 30 J/cm² | Experimental | Procedure: Low Level Laser Therapy, Device: GaAlAs laserThe irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients were 20 to 70 years old and of both genders, presenting Class I or II Miller gingival recession on vital canines or premolars in the palatine region (donor site) with no pathological or morphological alterations.
- Patients agreed to and signed the formal consent to participate in the study after receiving an explanation of risks and benefits from 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 (5 listed)
- Were excluded patients with systemic problems that contraindicated surgical procedure
- Those under medication that could interfere with the wound healing
- Those who smoked
- Those who were pregnant or lactating, and
- Those 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 |
|---|---|---|
| Low Level Laser TherapyAlso: Laser stimulationLow Level Laser Therapy on the palatal donor site of connective tissue graft. | Procedure or surgery | GaAlAs Laser therapy (LLLT) 30 J/cm², GaAlAs Laser therapy (LLLT) 60 J/cm², Low Level Laser therapy (LLLT) Sham |
| GaAlAs laserAlso: Low level GaAlAs laserUtilization of GaAlAs laser to irradiation on the palatal donor site. | Device | GaAlAs Laser therapy (LLLT) 30 J/cm², GaAlAs Laser therapy (LLLT) 60 J/cm², 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. These photographs were exported to image software ( Image J - NIH, Bethesda, USA) and remaining wound area was measured in square millimeters (mm²).
1 secondary outcome
Postoperative Discomfort
Time frame: 7, 14, 45, and 60 days after surgical procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14710766Zucchelli G, Amore C, Sforza NM, Montebugnoli L, De Sanctis M. Bilaminar techniques for the treatment of recession-type defects. A comparative clinical study. J Clin Periodontol. 2003 Oct;30(10):862-70. doi: 10.1034/j.1600-051x.2003.00397.x.
- Background: PubMed 7928129Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.
- Derived from this study: PubMed 27344670da Silva Neves FL, Silveira CA, Dias SB, Santamaria Junior M, de Marco AC, Kerbauy WD, de Melo Filho AB, Jardini MA, Santamaria MP. Comparison of two power densities on the healing of palatal wounds after connective tissue graft removal: randomized clinical trial. Lasers Med Sci. 2016 Sep;31(7):1371-8. doi: 10.1007/s10103-016-1988-6. Epub 2016 Jun 25.
- 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.
Mauro P Santamaria, PhD principal investigator
College of Dentistry - São José dos Campos, State University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy and GaAlAs laser in people with Palatal Wound, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
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 2 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 8 May 2017. 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?
Yes. Results are posted in the registry (first posted 8 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 NCT02580357, which also lists 3 linked publications.
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 May 2017.