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The Effect of Using Mobile Applications for Improving Oral Hygiene

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ClinicalTrials.gov Identifier: NCT03109769
Recruitment Status : Completed
First Posted : April 12, 2017
Results First Posted : November 1, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Orthodontic Appliance Complication
Interventions: Behavioral: Mobile phone application
Behavioral: Verbal oral hygiene instructions

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Mobile Phone Application

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

Mobile phone application

Verbal Oral Hygiene Instructions

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

Verbal oral hygiene instructions


Participant Flow:   Overall Study
    Mobile Phone Application   Verbal Oral Hygiene Instructions
STARTED   22   22 
COMPLETED   22   22 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Mobile Phone Application

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

Mobile phone application

Verbal Oral Hygiene Instructions

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

Verbal oral hygiene instructions

Total Total of all reporting groups

Baseline Measures
   Mobile Phone Application   Verbal Oral Hygiene Instructions   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   22   44 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 22   22   44 
   16.6  (3.2)   17.2  (5.2)   16.9  (4.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 22   22   44 
Female      11  50.0%      14  63.6%      25  56.8% 
Male      11  50.0%      8  36.4%      19  43.2% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 0   0   0 
         0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
     
Saudi Arabia       
Participants Analyzed 
[Units: Participants]
 22   22   44 
Saudi Arabia   22   22   44 


  Outcome Measures

1.  Primary:   Change in Plaque Index   [ Time Frame: At baseline and after 4 weeks. ]

2.  Primary:   Change in Gingival Index   [ Time Frame: At baseline and after 4 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Omar Alkadhi
Organization: Riyadh Colleges of Dentistry and Pharmacy
phone: 966505154754
e-mail: omar.alkadhi@riyadh.edu.sa



Responsible Party: Omar Alkadhi, Riyadh Colleges of Dentistry and Pharmacy
ClinicalTrials.gov Identifier: NCT03109769     History of Changes
Other Study ID Numbers: FUGRP/2014/191
First Submitted: April 5, 2017
First Posted: April 12, 2017
Results First Submitted: June 14, 2017
Results First Posted: November 1, 2017
Last Update Posted: November 1, 2017