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IRCT20220508054774N1 IRCT 2022-05-25 Birjand University of Medical Sciences The effect of low-level laser on complications after crown lengthening surgery in premolars The effect of low-level laser on complications after crown lengthening surgery in premolars 2020-11-04 anticipated 12 Complete https://irct.ir/trial/63368 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization with sealed envelope method. Numbers (from 1 to 12) were written for the expected number of patients and placed in a sealed envelope. After drawing, in the first half of the numbers that came out, the intervention area was considered on the right side and in the other half, on the left. Then, based on the time of admission of patients to the study, each patient was assigned a number Sequentially, Blinding description: In this study, participants and the examiner were considered blind. The paper containing the number assigned to each patient and the position of the intervention recipient side were handed directly to the laser irradiator in sealed envelopes without the examiner's notice. The laser device used in this study did not produce any signals that alerted the patient to irradiation or no irradiation. N/A Crown lengthening surgery of premolars. Intervention 1: Intervention group: In this Split-Mouth study, the intervention was low-level laser irradiation. After crown lengthening surgery in each patient, on the intervention side laser was irradiated. The AlGaAS 808nm diode laser was applied to the surgical area in parallel paths from coronal to apical with a power of 0.25 watts, an energy density of 4 joules per square centimeter using continuous irradiation settings. Intervention 2: Control group: In each patient, after crown lengthening surgery, on the control side laser device was placed in the mouth to resemble the irradiation for the patient, but in fact the device was turned off and no irradiation was performed. (Placebo). Yes - There is a plan to make this available What will be shared: Information about the main result and patient dental documents can be shared. Informed consent form, clinical study results, study protocol and codes used in the study are fully available. When: Access period starts 6 months after the results are published To whom: Academic researchers Conditions: Changes in primary outcomes cannot be cited in other studies because they are time-dependent. The final results of the study provide a suggestion for more detailed studies with greater scope and longer follow-up. Where to obtain: Dr. Marzieh Mohammadi Moghaddam: mohamadi_moghadam@yahoo.com Sajjad Abedzade: g.abedzade@gmail.com How to obtain: Sending an email, containing the name of the researcher, the title of the study or the reason for interest, and documents related to the academic researcher, if we see the email, the documents will be sent up to you one month later. Comments:
public Sajjad Abedzade
No. 36, Razavi 6 st., Razavi Blvd., Rezashahr
Mashhad Iran (Islamic Republic of) 9177757414 +98 51 3876 9719 g.abedzade@gmail.com Birjand University of Medical Sciences scientific Sajjad Abedzade
No. 36, Razavi 6 st., Razavi Blvd., Rezashahr
Mashhad Iran (Islamic Republic of) 9177757414 +98 51 3876 9719 g.abedzade@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) The need for crown lengthening surgery on at least two premolars without gingivitis on both sides of the jaw Informed consent 18 years 60 years Both Suffering from systemic diseases affecting wound healing Smoking Long-term use of corticosteroids and antibiotics Pregnancy and lactation Lack of informed consent Treatment - Devices Placebo Intervention group: In this Split-Mouth study, the intervention was low-level laser irradiation. After crown lengthening surgery in each patient, on the intervention side laser was irradiated. The AlGaAS 808nm diode laser was applied to the surgical area in parallel paths from coronal to apical with a power of 0.25 watts, an energy density of 4 joules per square centimeter using continuous irradiation settings. Control group: In each patient, after crown lengthening surgery, on the control side laser device was placed in the mouth to resemble the irradiation for the patient, but in fact the device was turned off and no irradiation was performed. (Placebo) The amount of tissue edema. Timepoint: One, three and seven days post-surgery. Method of measurement: Clinical examination checklist. Tissue color. Timepoint: One, three and seven days post-surgery. Method of measurement: Clinical examination checklist. Pain intensity. Timepoint: 24, 48 and 72 hours post-surgery. Method of measurement: Visual analogue scale. Birjand University of Medical Sciences Approved 2020-10-12 Ethics committee of Birjand University of Medical Sciences Ghafari Ave. Birjand South Khorasan Iran (Islamic Republic of)