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Comparison of Two Different Low-level Laser Intensity Protocols on the Healing of Palatal Wounds

Comparison of Two Different Low-level Laser Intensity Protocols on the Healing of Palatal Wounds After Connective Tissue Graft Removal: Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02580357
Enrollment
54
Registered
2015-10-20
Start date
2014-02-28
Completion date
2015-06-30
Last updated
2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palatal Wound

Keywords

Connective tissue graft, Gingival recession, Low level laser therapy

Brief 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.

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.

Interventions

PROCEDURELow Level Laser Therapy

Low Level Laser Therapy on the palatal donor site of connective tissue graft.

Utilization of GaAlAs laser to irradiation on the palatal donor site.

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* 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).

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in the Remaining Wound Area (RWA)7,14, 45 and 60 post operative daysFor 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).

Secondary

MeasureTime frameDescription
Postoperative Discomfort7, 14, 45, and 60 days after surgical procedureAfter 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.

Other

MeasureTime frameDescription
Tissue ThicknessBefore the procedure and 3 months after the procedureThrough four fixed points marked 5 and 7 mm from the gingival margin in the operated region, tissue thickness of palatine masticatory mucosa. One stent was made to standardize the points to be measured. The stent was positioned, and with a periodontal probe and the points were marked. Then the stent was removed and measurements were taken. For this, an endodontic spacer with a rubber cursor was put on the marked points for it to reach the palatine bone plate. Then the cursor was taken to the tissue carefully to not pressuring it. The distance between the spacer tip and the cursor was measured using a digital pachymeter and measured in millimeters (mm).

Participant flow

Recruitment details

At clinical site

Participants by arm

ArmCount
Low Level Laser Therapy (LLLT) Sham
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. Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft. GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
15
GaAlAs Laser Therapy (LLLT) 60 J/cm²
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. Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft. GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
18
GaAlAs Laser Therapy (LLLT) 30 J/cm²
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. Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft. GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
18
Total51

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up200
Overall StudyProtocol Violation100

Baseline characteristics

CharacteristicGaAlAs Laser Therapy (LLLT) 30 J/cm²TotalLow Level Laser Therapy (LLLT) ShamGaAlAs Laser Therapy (LLLT) 60 J/cm²
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
18 Participants51 Participants15 Participants18 Participants
Age, Continuous47 years
STANDARD_DEVIATION 9.3
43.4 years
STANDARD_DEVIATION 8.9
40.01 years
STANDARD_DEVIATION 7.6
43.2 years
STANDARD_DEVIATION 9.8
Region of Enrollment
Brazil
18 participants51 participants15 participants18 participants
Remaining wound area (RWA-mm2 )65.74 square millimeters
STANDARD_DEVIATION 25.08
59.6 square millimeters
STANDARD_DEVIATION 22.28
62.91 square millimeters
STANDARD_DEVIATION 23.27
50.15 square millimeters
STANDARD_DEVIATION 18.49
Sex: Female, Male
Female
11 Participants32 Participants8 Participants13 Participants
Sex: Female, Male
Male
7 Participants19 Participants7 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 150 / 180 / 18
serious
Total, serious adverse events
0 / 150 / 180 / 18

Outcome results

Primary

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).

Time frame: 7,14, 45 and 60 post operative days

ArmMeasureGroupValue (MEAN)Dispersion
Low Level Laser Therapy (LLLT) ShamChange in the Remaining Wound Area (RWA)RWA 14 days29.86 Square millimetersStandard Deviation 21.84
Low Level Laser Therapy (LLLT) ShamChange in the Remaining Wound Area (RWA)RWA 7 days62.91 Square millimetersStandard Deviation 23.27
Low Level Laser Therapy (LLLT) ShamChange in the Remaining Wound Area (RWA)RWA 45 days6.63 Square millimetersStandard Deviation 11.85
Low Level Laser Therapy (LLLT) ShamChange in the Remaining Wound Area (RWA)RWA 60 days5.52 Square millimetersStandard Deviation 9.37
GaAlAs Laser Therapy (LLLT) 60 J/cm²Change in the Remaining Wound Area (RWA)RWA 60 days2.33 Square millimetersStandard Deviation 2.95
GaAlAs Laser Therapy (LLLT) 60 J/cm²Change in the Remaining Wound Area (RWA)RWA 7 days50.15 Square millimetersStandard Deviation 18.49
GaAlAs Laser Therapy (LLLT) 60 J/cm²Change in the Remaining Wound Area (RWA)RWA 14 days28.38 Square millimetersStandard Deviation 13.89
GaAlAs Laser Therapy (LLLT) 60 J/cm²Change in the Remaining Wound Area (RWA)RWA 45 days8.17 Square millimetersStandard Deviation 6.66
GaAlAs Laser Therapy (LLLT) 30 J/cm²Change in the Remaining Wound Area (RWA)RWA 60 days3.08 Square millimetersStandard Deviation 2.96
GaAlAs Laser Therapy (LLLT) 30 J/cm²Change in the Remaining Wound Area (RWA)RWA 45 days7.45 Square millimetersStandard Deviation 7.93
GaAlAs Laser Therapy (LLLT) 30 J/cm²Change in the Remaining Wound Area (RWA)RWA 7 days65.74 Square millimetersStandard Deviation 25.08
GaAlAs Laser Therapy (LLLT) 30 J/cm²Change in the Remaining Wound Area (RWA)RWA 14 days27.67 Square millimetersStandard Deviation 16.16
Secondary

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.

Time frame: 7, 14, 45, and 60 days after surgical procedure

ArmMeasureGroupValue (MEAN)Dispersion
Low Level Laser Therapy (LLLT) ShamPostoperative DiscomfortPain 45 days0 units on a scaleStandard Deviation 0
Low Level Laser Therapy (LLLT) ShamPostoperative DiscomfortPain 60 days0 units on a scaleStandard Deviation 0
Low Level Laser Therapy (LLLT) ShamPostoperative DiscomfortPain 7 days0 units on a scaleStandard Deviation 0
Low Level Laser Therapy (LLLT) ShamPostoperative DiscomfortPain 14 days0 units on a scaleStandard Deviation 0
GaAlAs Laser Therapy (LLLT) 60 J/cm²Postoperative DiscomfortPain 7 days0 units on a scaleStandard Deviation 0
GaAlAs Laser Therapy (LLLT) 60 J/cm²Postoperative DiscomfortPain 14 days0 units on a scaleStandard Deviation 0
GaAlAs Laser Therapy (LLLT) 60 J/cm²Postoperative DiscomfortPain 60 days0.056 units on a scaleStandard Deviation 0.23
GaAlAs Laser Therapy (LLLT) 60 J/cm²Postoperative DiscomfortPain 45 days0 units on a scaleStandard Deviation 0
GaAlAs Laser Therapy (LLLT) 30 J/cm²Postoperative DiscomfortPain 60 days0 units on a scaleStandard Deviation 0
GaAlAs Laser Therapy (LLLT) 30 J/cm²Postoperative DiscomfortPain 7 days0 units on a scaleStandard Deviation 0
GaAlAs Laser Therapy (LLLT) 30 J/cm²Postoperative DiscomfortPain 14 days0 units on a scaleStandard Deviation 0
GaAlAs Laser Therapy (LLLT) 30 J/cm²Postoperative DiscomfortPain 45 days0 units on a scaleStandard Deviation 0
Other Pre-specified

Tissue Thickness

Through four fixed points marked 5 and 7 mm from the gingival margin in the operated region, tissue thickness of palatine masticatory mucosa. One stent was made to standardize the points to be measured. The stent was positioned, and with a periodontal probe and the points were marked. Then the stent was removed and measurements were taken. For this, an endodontic spacer with a rubber cursor was put on the marked points for it to reach the palatine bone plate. Then the cursor was taken to the tissue carefully to not pressuring it. The distance between the spacer tip and the cursor was measured using a digital pachymeter and measured in millimeters (mm).

Time frame: Before the procedure and 3 months after the procedure

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026