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IRCT20111130008257N3 IRCT 2020-08-02 Shiraz University of Medical Sciences Effect of lavender inhalation on the pain perception of orthodontic separator placement The effect of lavender inhalation on the pain perception of separator placement in patients needing orthodontic treatment: A randomized clinical trial 2020-07-25 anticipated 32 Complete https://irct.ir/trial/49614 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method is used. The length of the block is 8 and the number of treatment is 2. The statistician will randomly set the arrangement of blocks by random allocation software 2.0 and assigns them to the number of people. 16 bottles of lavender and 16 bottles of sesame oil are filled and the secretary gives one label A and the other B. Then, according to the list participants' medication is given , Blinding description: Participants, main researcher, effect Assessor, analyzer are all blind. The secretary assigns a label to each of the herbs: A and B. These substances are in the black bottle and only the secretary knows to which herb it belongs. We ask the patient to inhale the herb not knowing what it is. 3 orthodontic separator placement. Intervention 1: Intervention group: The participants have to instill five drops of lavender on a gauze and hold it about 20 cm from their nose for 5-10 minutes and breathe normally just before separator insertion, 4, 8, 12, 24, 36 and 48 hours afterward. Intervention 2: Control group: The participants have to instill five drops of sesame oil on a gauze and hold it about 20 cm from their nose for 5-10 minutes and breathe normally just before separator insertion, 4, 8, 12, 24, 36 and 48 hours afterward. Yes - There is a plan to make this available What will be shared: Age, Sex, The amount of pain according to visual analogue scale, The area of separator insertion When: Access period starts from 2021 To whom: Researchers working in academic and scientific institutions Conditions: Provided that the personal information of the participants is not disclosed and citing the relevant article is Where to obtain: Email: maryam_ta76@yahoo.com How to obtain: After introducing and ensuring the accuracy of the person's information, the data will be sent to him/her within a week. Comments:
public Maryam Tazarvi Fard Shirazi
Dentistry School of Shiraz University of Medical Science, Mehr Ave, Ghasrodasht Blvd
Shiraz Iran (Islamic Republic of) ۱۵۸۷۸- ۷۱۹۵۶ +98 71 3648 1369 maryam_ta76@yahoo.com Shiraz University of Medical Sciences scientific Maryam Karandish
Dentistry School of Shiraz University of Medical Science, Mehr Ave, Ghasrodasht Blvd
Shiraz Iran (Islamic Republic of) ۱۵۸۷۸- ۷۱۹۵۶ +98 71 3628 9913 karandishm@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Need separator placement to begin fixed orthodontic treatment in the maxillary and mandiblular arch Aged between 14 and 19 Patients who are informed and sign the written informed consent Who does not use antibiotics, analgesics, anti-inflammatory, anti-coagulatant, diuretics, oral anti diabetics, lithium, cyclosporine, and methotrexate Who has no need for antibiotic prophylaxis Who has no chronic systemic disease 14 years 19 years Both A patient who uses analgesics A patient who misses the session Early loss of separators A patient who wants to exit the survey Z46.4 Encounter for fitting and adjustment of orthodontic device Treatment - Drugs Placebo Intervention group: The participants have to instill five drops of lavender on a gauze and hold it about 20 cm from their nose for 5-10 minutes and breathe normally just before separator insertion, 4, 8, 12, 24, 36 and 48 hours afterward. Control group: The participants have to instill five drops of sesame oil on a gauze and hold it about 20 cm from their nose for 5-10 minutes and breathe normally just before separator insertion, 4, 8, 12, 24, 36 and 48 hours afterward. The amount of pain regarding to visual analogue scale. Timepoint: Just before separator placement, immediately after separator placement, 3 h post-treatment, 12 h post-treatment, 24 h post-treatment , and 48 h after separator placement. Method of measurement: Visual analogue scale questionnaire. Shiraz University of Medical Sciences Approved 2020-06-21 Ethics committee of Shiraz University of Medical Sciences Dentistry School, Shiraz University of Medical Sciences, Mehr Ave, Qasrodasht Blvd Shiraz Fars Iran (Islamic Republic of)