Trial Outcomes & Findings for The Effect of Using Mobile Applications for Improving Oral Hygiene (NCT NCT03109769)
NCT ID: NCT03109769
Last Updated: 2019-01-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
At baseline and after 4 weeks.
Results posted on
2019-01-15
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Mobile Phone Application
n=22 Participants
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
n=22 Participants
Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.
Verbal oral hygiene instructions
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.6 years
STANDARD_DEVIATION 3.2 • n=22 Participants
|
17.2 years
STANDARD_DEVIATION 5.2 • n=22 Participants
|
16.9 years
STANDARD_DEVIATION 4.4 • n=44 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=22 Participants
|
14 Participants
n=22 Participants
|
25 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=22 Participants
|
8 Participants
n=22 Participants
|
19 Participants
n=44 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Saudi Arabia
|
22 Participants
n=22 Participants
|
22 Participants
n=22 Participants
|
44 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mobile Phone Application
n=22 Participants
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
n=22 Participants
Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.
Verbal oral hygiene instructions
|
|---|---|---|
|
Change in Plaque Index
Plaque index after 4 weeks
|
0.6677 units on a scale
Standard Deviation 0.3146
|
0.9891 units on a scale
Standard Deviation 0.5244
|
|
Change in Plaque Index
Plaque index at baseline
|
0.8050 units on a scale
Standard Deviation 0.4062
|
0.8959 units on a scale
Standard Deviation 0.4824
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mobile Phone Application
n=22 Participants
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
n=22 Participants
Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.
Verbal oral hygiene instructions
|
|---|---|---|
|
Change in Gingival Index
Gingival index at baseline
|
0.3450 units on a scale
Standard Deviation 0.2955
|
0.4927 units on a scale
Standard Deviation 0.3005
|
|
Change in Gingival Index
Gingival index after 4 weeks
|
0.2273 units on a scale
Standard Deviation 0.2256
|
0.5941 units on a scale
Standard Deviation 0.5679
|
Adverse Events
Mobile Phone Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Verbal Oral Hygiene Instructions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place