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IRCT20190210042679N1 IRCT 2020-02-11 Semnan University of Medical Sciences Evaluation of ٍDiode Laser in Frenectomy Comparison of Complications and Patients' Satisfaction using Diode laser versus Conventional Technique in Labial Frenectomy 2019-07-23 anticipated 20 Complete https://irct.ir/trial/38558 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are allocated randomly with simple sequential allocation in one of the two study groups by help of sealed envelope and receive the intervention of the same group. The unit of randomization is patient. Sealed envelopes are delivered to expert. With each patient's visit, one of the envelopes is randomly selected by the patients and determines the study group. The stratification approach is not used. N/A Labial frenectomy. Intervention 1: Intervention group:Patients undergo frenectomy according to the protocol using diode laser. First we numb the area. Then hold the top and bottom of the phrenom with the help of two hemostats. With the help of a diode laser, extra tissue is cut. The surgical area will be covered by CO-PAK periodontal dressing. Intervention 2: Control group: Patients underwent frenectomy according to the protocol standard surgical procedure. First we numb the area. Using a coronal razor number 15, extra tissue is cut. Then the incision with a suture 0.3 silk, We stitch. Yes - There is a plan to make this available What will be shared: Some of the data is shared, such as information about the main outcome When: Start of access period 6 months after printing results To whom: Researchers working in academic and scientific institutions Conditions: For re-study or scientific use Where to obtain: Hanieh Raz raz_hanie@yahoo.com How to obtain: Send an email containing the request for access to the study and the type of study use with the applicant's specification Check email Send data Comments:
public Hanieh Raz
Beside Range Tavakol, Mirzaye shirazi Blvd, Mashahir square
Semnan Iran (Islamic Republic of) 3519697344 +98 23 3332 1026 raz_hanie@yahoo.com Semnan University of Medical Sciences scientific Maryam Jalili Sadrabaad
Faculty of Dentistry, Oral and Maxillofacial Diseases, 17 Shahrivar Blvd, Semnan
Semnan Iran (Islamic Republic of) 3518794430 +98 23 3332 1026 dr.njalili@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Patients between 18 to 40 years old are admitted. patients who need labial Frenectomy treatment. 18 years 40 years Both Present of systemic diseases Present of diabetes Present of immunodeficiency Taking aspirin Present of scleroderma Addiction History of delayed wound healing Treatment - Surgery Treatment - Surgery Intervention group:Patients undergo frenectomy according to the protocol using diode laser. First we numb the area. Then hold the top and bottom of the phrenom with the help of two hemostats. With the help of a diode laser, extra tissue is cut. The surgical area will be covered by CO-PAK periodontal dressing. Control group: Patients underwent frenectomy according to the protocol standard surgical procedure. First we numb the area. Using a coronal razor number 15, extra tissue is cut. Then the incision with a suture 0.3 silk, We stitch. Bleeding severity measure. Timepoint: One week and one month after surgery. Method of measurement: The intensity of bleeding will be recorded with a rating of 0 to 5. Satisfaction and pain. Timepoint: One week and one month after surgery. Method of measurement: Visual Analogue Scale (VAS) -10cm. Semnan University of Medical Sciences Approved 2019-11-02 Ethics Committee of Semnan University of Medical Sciences Vice chancellor for research, Semnan University of Medical Sciences building, Basij Blvd Semnan Semnan Iran (Islamic Republic of)