Orthodontic Appliance ComplicationNCT03109769

The Effect of Using Mobile Applications for Improving Oral Hygiene

A study testing Mobile phone application and Verbal oral hygiene instructions in people with Orthodontic Appliance Complication, run by Riyadh Colleges of Dentistry and Pharmacy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for: Orthodontic Appliance Complication
What is being tested?: Mobile phone application and Verbal oral hygiene instructions
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: No sites listed yet
Study dates: 12 Feb 2016to 4 Nov 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

None listed.

About this study

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

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.

Read the 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.

Conditions: Orthodontic Appliance Complication
Being tested: Mobile phone application, Verbal oral hygiene instructions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mobile phone applicationBehavioural
Verbal oral hygiene instructionsBehavioural

Study groups in NCT03109769
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Verbal oral hygiene instructions

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: At baseline and after 4 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Feb 20164 Nov 2016

First posted12 Apr 2017
Study start12 Feb 2016
Primary completion25 Jul 2016
Study completion4 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03109769
Sponsor's protocol ID: FUGRP/2014/191
Status last verified: Dec 2018
First submitted: 5 Apr 2017
Last updated: 15 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 28705122

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Orthodontic Appliance Complication trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Using Mobile Applications for Improving Oral Hygiene in Patients With Orthodontic Fixed Appliances: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03109769
Acronym / sponsor ID: FUGRP/2014/191
Conditions: Orthodontic Appliance Complication
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
Study start: 12 Feb 2016 (actual)
Primary completion: 25 Jul 2016 (actual)
Study completion: 4 Nov 2016 (actual)
First posted: 12 Apr 2017 (actual)
Results: Posted 1 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Mobile phone application	Experimental	Behavioral: Mobile phone applicationSubjects 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 instructionsSubjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mobile phone application	Behavioural	Mobile phone application
Verbal oral hygiene instructions	Behavioural	Verbal oral hygiene instructions

Primary outcome

Change in Plaque Index
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 1 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mobile Phone Application	22	22
Verbal Oral Hygiene Instructions	22	22

Primary outcome: Change in Plaque Index

Time frame: At baseline and after 4 weeks.. Mean (Standard Deviation). Unit: units on a scale

Measure	Mobile Phone Application n = 22	Verbal Oral Hygiene Instructions n = 22
Plaque index at baseline	0.8050 (0.4062)	0.8959 (0.4824)
Plaque index after 4 weeks	0.6677 (0.3146)	0.9891 (0.5244)

Mobile Phone Application vs Verbal Oral Hygiene Instructions: p = 0.0444, Wilcoxon (Mann-Whitney)
Mobile Phone Application: Mean Difference (Net): -0.1373, p = 0.0002, Wilcoxon (Mann-Whitney)
Mobile Phone Application: Median Difference (Final Values): 0.0932, p = 0.0283, Wilcoxon (Mann-Whitney)

Primary outcome: Change in Gingival Index

Time frame: At baseline and after 4 weeks.. Mean (Standard Deviation). Unit: units on a scale

Measure	Mobile Phone Application n = 22	Verbal Oral Hygiene Instructions n = 22
Gingival index at baseline	0.3450 (0.2955)	0.4927 (0.3005)
Gingival index after 4 weeks	0.2273 (0.2256)	0.5941 (0.5679)

Mobile Phone Application vs Verbal Oral Hygiene Instructions: p = 0.0283, Wilcoxon (Mann-Whitney)
Mobile Phone Application: Mean Difference (Net): -0.1177, p = 0.0002, Wilcoxon (Mann-Whitney)
Verbal Oral Hygiene Instructions: Mean Difference (Net): 0.1014, p = 0.4809, Wilcoxon (Mann-Whitney)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mobile Phone Application	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Verbal Oral Hygiene Instructions	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28705122Alkadhi 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.
Individual participant dataSharing planned: No

Related trials for Orthodontic Appliance Complication

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Bacterial Diversity Study Using 16S rRNA Sequencing of Periodontal Samples From Patients With Orthodontic Retainers
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Omar H AlKadhi, BDS, MS principal investigator

Riyadh Colleges of Dentistry and Pharmacy

Questions about this trial

What is this clinical trial studying?

A study testing Mobile phone application and Verbal oral hygiene instructions in people with Orthodontic Appliance Complication, run by Riyadh Colleges of Dentistry and Pharmacy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Plaque Index (time frame: At baseline and after 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03109769, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019; AzTrials last refreshed its copy on 31 Oct 2026.