NCT03109769

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
7 months until next milestone

Results Posted

Study results publicly available

November 1, 2017

Completed
Last Updated

January 15, 2019

Status Verified

December 1, 2018

Enrollment Period

5 months

First QC Date

April 5, 2017

Results QC Date

June 14, 2017

Last Update Submit

December 27, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 and after 4 weeks.

  • 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 and after 4 weeks.

Study Arms (2)

Mobile phone application

EXPERIMENTAL

Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.

Behavioral: Mobile phone application

Verbal oral hygiene instructions

ACTIVE COMPARATOR

Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.

Behavioral: Verbal oral hygiene instructions

Interventions

Mobile phone application
Verbal oral hygiene instructions

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Results Point of Contact

Title
Omar Alkadhi
Organization
Riyadh Colleges of Dentistry and Pharmacy

Study Officials

  • Omar H AlKadhi, BDS, MS

    Riyadh Colleges of Dentistry and Pharmacy

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 12, 2017

Study Start

February 12, 2016

Primary Completion

July 25, 2016

Study Completion

November 4, 2016

Last Updated

January 15, 2019

Results First Posted

November 1, 2017

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share