The Effect of Using Mobile Applications for Improving Oral Hygiene

NCT03109769 — Not applicable, Completed, 44 participants, Riyadh Colleges of Dentistry and Pharmacy

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The Effect of Using Mobile Applications for Improving Oral Hygiene in Patients With Orthodontic Fixed Appliances: A Randomized Controlled Trial

Registry	NCT03109769
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, prevention
Enrollment	44 (Actual)
Sponsor	Riyadh Colleges of Dentistry and Pharmacy (Other)
Conditions	Orthodontic Appliance Complication
Interventions	Mobile phone application, Verbal oral hygiene instructions (Behavioral)
Dates	start 2016-02-12, primary completion 2016-07-25, completion 2016-11-04, first posted 2017-04-12, last updated 2019-01-15

-Summary

The study aims to investigate the effect of the use of mobile phone application sending reminders to patients with orthodontic fixed appliances on oral hygiene.

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+Detailed description

Subjects were randomized into two groups, the first group received a mobile application that sends active reminders notifications of oral hygiene. The second group received verbal oral hygiene instructions during their regular visits to the orthodontics clinics.

+Arms and interventions

Arm	Type	Interventions	Description
Mobile phone application	Experimental	Behavioral: Mobile phone application	Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.
Verbal oral hygiene instructions	Active comparator	Behavioral: Verbal oral hygiene instructions	Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.

Mobile phone application (Behavioral)
Verbal oral hygiene instructions (Behavioral)

+Outcome measures

Primary outcomes

Change in Plaque Index [At baseline and after 4 weeks.]: 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.
Change in Gingival Index [At baseline and after 4 weeks.]: 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.

+Eligibility

Sex: All, ages: 12 Years to any, accepts healthy volunteers

Inclusion Criteria:

1. Participants were having orthodontic fixed appliance treatment.
2. Participants were aged 12 years old and above, owned mobile phones and did not have mental or physical disabilities.
3. Participants were willing to comply with given oral hygiene instructions.

+Posted results

Participant flow

Milestone	Mobile Phone Application	Verbal Oral Hygiene Instructions
Started	22	22
Completed	22	22
Not completed	0	0

Outcome results

Change in Plaque Index (Primary), Mean, units on a scale: Mobile Phone Application 0.8050 +/- 0.4062; Verbal Oral Hygiene Instructions 0.8959 +/- 0.4824 (p 0.0444)
Change in Gingival Index (Primary), Mean, units on a scale: Mobile Phone Application 0.3450 +/- 0.2955; Verbal Oral Hygiene Instructions 0.4927 +/- 0.3005 (p 0.0283)

Adverse events

Arm	Deaths	Serious adverse events	Other adverse events
Mobile Phone Application	0/22 (0.0%)	0/22 (0.0%)	0/22 (0.0%)
Verbal Oral Hygiene Instructions	0/22 (0.0%)	0/22 (0.0%)	0/22 (0.0%)

+Publications

Results publication: Alkadhi OH, Zahid MN, Almanea RS, Althaqeb HK, Alharbi TH, Ajwa NM. The effect of using mobile applications for improving oral hygiene in patients with orthodontic fixed appliances: a randomised controlled trial. J Orthod. 2017 Sep;44(3):157-163. doi: 10.1080/14653125.2017.1346746. Epub 2017 Jul 13. PMID 28705122

+Investigators

Omar H AlKadhi, BDS, MS, Principal investigator, Riyadh Colleges of Dentistry and Pharmacy