Fosjc-Unesp
São Jose Dos Campos/ SP, Non-US Resident, 12245-000, Brazil
NCT Number: NCT02239042
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.
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Notify Me20 year–70 year
All sexes
Interventional
Phase 4
São Jose Dos Campos/ SP, Non-US Resident, 12245-000, Brazil
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Low-level laser therapy (LLLT) after Coronally advanced falp and connective tissue graft technique to treat gingival recessions on the donor site
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
Time frame: 7, 14, 45 and 60 days after surgical procedure
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.
Time frame: Before and 90 days after surgery
Through four fixed points (5mm and 7mm distant to gingival margin) from the operated region, tissue thickness of palatine masticatory mucosa before the procedure and 3 months after the procedure were assessed. One stent was made to standardize the points to be measured. The stent was positioned and, with a periodontal probe, the points were marked. Then the stent was removed and measures were made. For this, an endodontic spacer with a rubber cursor was put on the marked points for it to reach palatine bone plate. Then the cursor was taken to the tissue, not pressuring it. The distance between the spacer tip to the cursor was measured using a digital caliper
UPECLIN HC FM Botucatu Unesp
Other
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
Acronym: LLLT
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