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IRCT2017092036203N2 IRCT 2017-11-01 Private The effect of laser therapy on the healing of human palatal wound after free gingival graft surgery Effects of Ga Al As 940nm low-level laser therapy on the healing of human palatal mocusa after free gingival graft surgery:a clinical trial study 2017-11-22 anticipated 16 Complete https://irct.ir/trial/27132 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. N/A Palatal wound after free gingival graft surgery. Intervention 1: The patients allocated for the test group will receive the following protocol for laser application: A GaAlAs laser will be used for irradiation at a wavelength of 940 nm, an intensity that had been previously calibrated by the manufacturer.(Ezlase; Biolase Technology Inc., Irvine,CA, USA). The wounds of each experimental group receive laser stimulation at doses of 5J/cm2. The power output is maintained at a constant 0.21 W in the continuous-wave (cw) mode; The spot size is 1.26 cm2, the total energy dose per session is 6.3 J, and powerdensity is 0.16 W/cm2. Laser energy will be applied via a 400 micron optical fiber. The optical fiber is positioned at a distance of approximately 5 mm proximal to the wound, and the irradiation time is 30 s. The experimental groups will receive their first dose of irradiation immediately after surgery and within ten days, one day apart following the surgery for a total of 5 sessions. Intervention 2: The patients allocated to the control group will receive sham irradiation. For this, rubber protection is placed at the tip of the laser device, which don't allow the light to reach the tissue. The applications will be performed by a different operator from the one who measure the study parameters.
public Ghazal Morshedzade Tehrani
Dentistry faculty of Tehran University of Medical Sciences, North Karegar St, Tehran
Tehran Iran (Islamic Republic of) +98 21 8888 3575 ghzlmt@gmail.com Dentistry Faculty of Tehran University of Medical Sciences scientific Dr. Hoori Asl Roosta
Department of Periodontology, Third floor, Dentistry Faculty of Tehran University of Medical Sciences, North Karegar St, Tehran
Tehran Iran (Islamic Republic of) +98 912 547 0342 h-aslroosta@sina.tums.ac.ir Dentistry Faculty of Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: patents aged between 20 and 70 years old, systemically healthy, keratinized tissue width<1mm , Full Mouth Plaque Score (FMPS)<20%, Full Mouth Bleeding Score (FMBS)<20%, absence of pathological or morphological alterations in the palatal region (donor site). Exclusion criteria: presence of gag reflex, smoking, presence of proximal bone loss, loss of sensation in palatal mucosa, tooth mobility and/or occlusal trauma in corresponding area, excessive forces (e.g., mechanical forces from orthodontics and traumatic occlusions), systematic diseases that would contraindicate periodontal surgery or interfere with tissue healing such as diabetes, chronic high dose steroid therapy, history of radiation or immuno-suppressive therapy, pregnancy, lactation, gastro-intestinal problems, hyper sensitivity to impression materials, history of drug therapies that are known to interfere with healing or cause gingival enlargement, and patients not complying with postoperative protocols and/or attending their visits irregularly. 20 years 70 years Both K13.7 Other and unspecified lesions of oral mucosa Rehabilitation Placebo The patients allocated for the test group will receive the following protocol for laser application: A GaAlAs laser will be used for irradiation at a wavelength of 940 nm, an intensity that had been previously calibrated by the manufacturer.(Ezlase; Biolase Technology Inc., Irvine,CA, USA). The wounds of each experimental group receive laser stimulation at doses of 5J/cm2. The power output is maintained at a constant 0.21 W in the continuous-wave (cw) mode; The spot size is 1.26 cm2, the total energy dose per session is 6.3 J, and powerdensity is 0.16 W/cm2. Laser energy will be applied via a 400 micron optical fiber. The optical fiber is positioned at a distance of approximately 5 mm proximal to the wound, and the irradiation time is 30 s. The experimental groups will receive their first dose of irradiation immediately after surgery and within ten days, one day apart following the surgery for a total of 5 sessions. The patients allocated to the control group will receive sham irradiation. For this, rubber protection is placed at the tip of the laser device, which don't allow the light to reach the tissue. The applications will be performed by a different operator from the one who measure the study parameters. Remaining Wound Area. Timepoint: On the day of surgery and on the 7th , 14th, 28th, 60th days after surgery. Method of measurement: Image J software (mm2). Pain. Timepoint: The first 10 days after surgery. Method of measurement: Questionaire (VAS). Epithelialization. Timepoint: On the 7th , 14th, 28th, 60th days after surgery. Method of measurement: By means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface (total, partial or none). Secondary bleeding. Timepoint: The first 10 days after surgery. Method of measurement: Questionaire. Colour Match (brightness parameters). Timepoint: On the 7th , 14th, 28th, 60th days after surgery. Method of measurement: Adobe photoshop software. Private Approved 2017-09-10 Ethics Committee of Dentistry Faculty of Tehran University of Medical Sciences Dentistry Faculty of Tehran University of Medical Sciences, North Karegar St, Tehran, Iran Tehran Iran (Islamic Republic of)