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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03330535
Other study ID # FRP/2018/27
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date December 2019

Study information

Verified date December 2018
Source Riyadh Colleges of Dentistry and Pharmacy
Contact Omar H Alkadhi, BDS,MS
Phone 966505154754
Email omar.alkadhi@riyadh.edu.sa
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate the efficacy of text message active reminders at different time intervals of oral hygiene instructions in patients with orthodontic fixed appliances.


Description:

Participants with orthodontic fixed appliances will be recruited from the university hospital clinics to receive text message reminders of oral hygiene. Four groups of participants will be formulated. Group 1 will be the control group and will not receive text messages. Group 2 will receive messages once a week. Group 3 will receive text message reminders 3 times a week. Group 4 will receive daily reminders. At baseline, after 4 weeks and after 8 weeks, gingival index and plaque index will be measured at each time point and then compared between groups.


Recruitment information / eligibility

Status Recruiting
Enrollment 88
Est. completion date December 2019
Est. primary completion date October 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Participants were having orthodontic fixed appliance treatment.

- Participants were aged 12 years old and above, owned mobile phones and did not have mental or physical disabilities.

- Participants were willing to comply with given oral hygiene instructions.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Reminders once a week
Participants in this group will receive active oral hygiene reminders through text messaging once a week.
Verbal oral hygiene instructions
Participants in this group will receive verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.
Reminders three times a week
Participants in this group will receive active oral hygiene reminders through text messaging three times a week.
Daily reminders
Participants in this group will receive active oral hygiene reminders through text messaging on a daily basis.

Locations

Country Name City State
Saudi Arabia Riyadh Elm University Riyadh Ar Riyad

Sponsors (1)

Lead Sponsor Collaborator
Riyadh Colleges of Dentistry and Pharmacy

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Plaque Index Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque. At baseline, 4 weeks and 8 weeks
Primary Change in gingival index Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding. At baseline, 4 weeks and 8 weeks
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