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IRCT20180923041092N2 IRCT 2020-07-25 Shiraz Branch, Islamic Azad University Effect of Reminders on Oral Hygiene Promotion Effect of Text Message Reminders on Oral Hygiene Promotion During Removable Orthodontic Treatment 2019-04-20 anticipated 50 Complete https://irct.ir/trial/47612 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants were randomized according to the minimization method proposed by Pandis. Minimization is a method of randomization used to ensure the balance of important prognostic factors among the groups and does not have the disadvantages of other randomization methods. List of randomization was not prepared in this method before the beginning of study; instead, it was prepared in the process of selection of participants. It is a dynamic method of randomization. In the Minimization method, the first participant randomly entered into one of the groups and the next participant is entered into a group that has a lower predetermined factor in that group. for example, if the first participant, who is an 8-year-old boy, joins the intervention group, the second participant who is a 10-year-old boy, will enter the to control group, by this way balance can be obtained in one of the predetermined factor "the sexuality" at least. Minimization can be easily performed using software (Minim). However, the important point before using this software is to determine the important prognostic factors between groups, Blinding description: 1. Examiner clinician 2.Person performed the data entry 3. Statistician were unaware of patients group. N/A The normal gingiva may range in color from light coral pink to heavily pigmented. It is normally stippled in appearance (resembling an orange peel). The makeup of the gingival tissue varies according to its location and function. There are two types of gingiva and several important anatomic regions.Free gingiva – This tissue is not attached and forms a collar around the tooth. The trough around the tooth is called the sulcus and its depth is normally 1-3 mm. It is lined with sulcular epithelium and attached to the tooth at its base by the epithelial attachment.Gingival margin – The border region of the gingiva that touches the tooth.Interdental papillae – The region of gingival tissue that fills the space between adjacent teeth. In a healthy mouth this is usually knife-edged and fills the interdental space.Muco-gingival junction – The scalloped line that divides the attached gingiva from the alveolar mucosa.. Intervention 1: Intervention group: In the first phase (T1), the messaging group received video and text messages containing information about the significance of oral hygiene twice a week for 4 weeks. Time of sending the text messages was determined such that both the parents and patients were at home. The time interval between lunch and dinner was often chosen for most patients. For the rest of the patients, a convenient time was arranged following discussion with the parents. In the second phase (T2), patients received a message reminder for oral hygiene and educational videos once a week for 2 months. In the third phase (T3), message reminders were sent to the messaging group once a week for 3 months. Plaque index (PI), gingival index (GI) were recorded at baseline (T0) and one (T1), three (T2) and six (T3) months after the first day of treatment by the same blinded examiner who did not have any information about participant’s division in the two groups. Intervention 2: Control group: They received no video and text messages containing information about the significance of oral hygiene during study. Plaque index (PI), gingival index (GI) were recorded at baseline (T0) and one (T1), three (T2) and six (T3) months after the first day of treatment by the same blinded examiner who did not have any information about participant’s division in the two groups. Yes - There is a plan to make this available What will be shared: Effect Message Reminders on Oral Hygiene Promotion During Removable Orthodontic Treatment When: Data is available after the article is published To whom: For all those who have an official request. Conditions: None of the patients' names should be mentioned anywhere Where to obtain: It is available through the زcorresponding for information. How to obtain: Official request from the University's Vice Chancellor for Research Comments:
public Tahereh Baheri Moghadam
Ghaani Street, 14h Alley, Dental School
Shiraz Iran (Islamic Republic of) 7184735716 +98 71 3830 8200 T_baheri@yahoo.com Shiraz Branch, Islamic Azad Univeristy scientific Navid Naseri
Staarkhan Street, 11 th Alley
Shiraz Iran (Islamic Republic of) 7184735716 +98 71 3649 1516 NavidNaseri@gmail.com Shiraz Branch, Islamic Azad University Iran (Islamic Republic of) ‌Being orthodontic patients for 6 months at least Having removable orthodontic appliance made of auto-polymerizing acrylic resin with a midline screw 8 years 12 years Both No daily access to Internet by smartphone or parents were not at home at the time of sending text messages due to their occupational schedule Specific nutritional regimens Systemic diseases Syndromic anomalies such as cleft lip or palate and physical or mental disability. K05 Gingivitis and periodontal diseases Rehabilitation Rehabilitation Intervention group: In the first phase (T1), the messaging group received video and text messages containing information about the significance of oral hygiene twice a week for 4 weeks. Time of sending the text messages was determined such that both the parents and patients were at home. The time interval between lunch and dinner was often chosen for most patients. For the rest of the patients, a convenient time was arranged following discussion with the parents. In the second phase (T2), patients received a message reminder for oral hygiene and educational videos once a week for 2 months. In the third phase (T3), message reminders were sent to the messaging group once a week for 3 months. Plaque index (PI), gingival index (GI) were recorded at baseline (T0) and one (T1), three (T2) and six (T3) months after the first day of treatment by the same blinded examiner who did not have any information about participant’s division in the two groups. Control group: They received no video and text messages containing information about the significance of oral hygiene during study. Plaque index (PI), gingival index (GI) were recorded at baseline (T0) and one (T1), three (T2) and six (T3) months after the first day of treatment by the same blinded examiner who did not have any information about participant’s division in the two groups. Gingival inflammation. Timepoint: After one, three, and six month. Method of measurement: By using silness loe index. Periodontal pocket depth. Timepoint: After one, three, and six month. Method of measurement: By using periodontal probe. Shiraz Branch, Islamic Azad University Approved 2020-06-19 Kazerun Branch, Islamic Azad University, Iran. 5 km of Kazerun-Bushehr road Kazerun Fars Iran (Islamic Republic of)