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IRCT20210618051613N1 IRCT 2021-06-30 Tehran University of Medical Sciences Comparison of pain perception during anesthetic needle insertion with and without diode laser irradiation in adults Comparison of pain perception during anesthetic needle insertion in local infiltration in anterior maxilla with and without diode laser irradiation in adults: a randomized clinical trial 2021-06-30 anticipated 32 Complete https://irct.ir/trial/56956 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Dent 88, Italy , 915nm wavelength, power of 1.5W and energy density of 238.8J/cm2 for 40 S of diode laser, Randomization description: 32 empty envelops are given to the statistician and he randomly allocates them to A and B groups based on diode laser irradiation or shame laser. These sealed envelopes are then released to the project manager. Thus, a random allocation list is prepared. Random block sequence is formed using a table of random numbers. A sealed envelope is randomly selected by the project manager and it is presented to the person who applies the laser irradiation. After laser treatment (shame laser or active irradiation), the injection is performed by the student, while the student and the patient are completely blind regarding type of laser treatment. Therefore, half of the patients receive shame laser before injection in the first week and receive active laser irradiation on the following week. The treatment sequence is reverse for the second group of the patients, Blinding description: The patients are blinded to type of intervention. The patient is completely informed about the research process and a consent form is achieved. However, the patient does not know that in which group he or she will be allocated. Portable dental diode laser device is available in the surgery. Diode laser is irradiated in the intervention group and it is turned off in the control group. The person who does the injection is blind as well. The patient evaluates the pain severity. 3 1- Pain perception during needle insertion of local anesthesia 2- The effect of laser irradiation on pain perception. Intervention 1: The intervention group consisted of patients aged 20 to 50 year-old who referred to the restorative dentistry department of Tehran University of Medical Sciences for restoration of maxillary anterior teeth in two opposite quadrants. The teeth with carious lesion not extended to inner third of dentin were selected. It was determined by radiographic examination. Patients who meet the inclusion criteria are explained about the treatment procedures and written consent form is received from the volunteers who participated in this research program. Lidocaine (concentration of 1.80,000 epinephrine) (Darupakhsh Co.) is the anesthetics agent that is used in this study. One third of carpule (1.8mL) in injected for anesthesia. Diode laser characteristics were determined after conducting a pilot study on 6 volunteers. does not cause soft or hard tissue damage or pulpal tissue irritation after 40 seconds of radiation. Diode aser device is calibrated before treatment procedure. The minimum and maximum time interval between the laser irradiation and the injection is between 2 to 5 minutes. The mucobuccal fold is first dried with a cotton roll and the upper lip is retracted with the fingers and the laser tip is touched with mucusa at the injection area without pressure for 40S. Local infiltration is performed by the second operator afterwards using 27-gauge short needle. In this study, supraperiosteal injection method (local infiltration injection) is used for dental anesthesia of maxillary anterior teeth. The second appointment for restorative treatment is scheduled one week later for washing out period. The pain perception is marked in the numerical pain intensity scale by the patient immediately after injection. All the patients are trained how to mark the numerical pain intensity scale before treatment session. Intervention 2: Control group: Shame laser. No - There is not a plan to make this available Justification or reason for not sharing IPD is One of the reasons of contribution of participants in the research project and getting consent form is, hiding the personal information
public Fariba Motevasselian
خیابان کارگرشمالی
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8801 5088 f-motevasselian@sina.tums.ac.ir Tehran University of Medical Sciences scientific Fariba Motevasselian
North Karegar Street
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8801 5088 f-motevasselian@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Adult Patients who are physiologically in healthy condition determined using a questionnaires filled by the student Adult patients who need restoring two maxillary incisors in the opposite quadrants. 20 years 50 years Both 1-Patients that local anesthesia application with epinephrine vasoconstrictor is contraindicated such as patient with high blood pressure.. Patients who have mental illness such a depression, anxiety or epilepsy3 Patients who take analgesics (pain killer) Patients who smoke tobacco Patients who have severely destroyed painful teeth, teeth required endodontic treatment Patients who have painful soft or hard tissue lesions Patienrs who wear removable dentures caused denture stomatitis Patients with orofacial pain Treatment - Devices Treatment - Devices The intervention group consisted of patients aged 20 to 50 year-old who referred to the restorative dentistry department of Tehran University of Medical Sciences for restoration of maxillary anterior teeth in two opposite quadrants. The teeth with carious lesion not extended to inner third of dentin were selected. It was determined by radiographic examination. Patients who meet the inclusion criteria are explained about the treatment procedures and written consent form is received from the volunteers who participated in this research program. Lidocaine (concentration of 1.80,000 epinephrine) (Darupakhsh Co.) is the anesthetics agent that is used in this study. One third of carpule (1.8mL) in injected for anesthesia. Diode laser characteristics were determined after conducting a pilot study on 6 volunteers. does not cause soft or hard tissue damage or pulpal tissue irritation after 40 seconds of radiation. Diode aser device is calibrated before treatment procedure. The minimum and maximum time interval between the laser irradiation and the injection is between 2 to 5 minutes. The mucobuccal fold is first dried with a cotton roll and the upper lip is retracted with the fingers and the laser tip is touched with mucusa at the injection area without pressure for 40S. Local infiltration is performed by the second operator afterwards using 27-gauge short needle. In this study, supraperiosteal injection method (local infiltration injection) is used for dental anesthesia of maxillary anterior teeth. The second appointment for restorative treatment is scheduled one week later for washing out period. The pain perception is marked in the numerical pain intensity scale by the patient immediately after injection. All the patients are trained how to mark the numerical pain intensity scale before treatment session. Control group: Shame laser Pain perception by patient according to numerical pain intensity scale. Timepoint: Immediately after local infiltration. Method of measurement: numerical pain intensity scale. Vice Chancellor for Education, School of Dentistry, University of Tehran Approved 2021-04-04 Tehran University of Medical Sciences, School of Dentistry North Karegar street Tehran Tehran Iran (Islamic Republic of)