Orthodontic Appliance Complication
Conditions
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.
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.
Interventions
BEHAVIORALMobile phone application
BEHAVIORALVerbal oral hygiene instructions
Sponsors
Riyadh Colleges of Dentistry and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 22 |
| 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 | 22 |
| Total | 44 |
Baseline characteristics
| Characteristic | Verbal Oral Hygiene Instructions | Total | Mobile Phone Application |
|---|---|---|---|
| Age, Continuous | 17.2 years STANDARD_DEVIATION 5.2 | 16.9 years STANDARD_DEVIATION 4.4 | 16.6 years STANDARD_DEVIATION 3.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Saudi Arabia | 22 Participants | 44 Participants | 22 Participants |
| Sex: Female, Male Female | 14 Participants | 25 Participants | 11 Participants |
| Sex: Female, Male Male | 8 Participants | 19 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
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.
Time frame: At baseline and after 4 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile Phone Application | Change in Gingival Index | Gingival index at baseline | 0.3450 units on a scale | Standard Deviation 0.2955 |
| Mobile Phone Application | Change in Gingival Index | Gingival index after 4 weeks | 0.2273 units on a scale | Standard Deviation 0.2256 |
| Verbal Oral Hygiene Instructions | Change in Gingival Index | Gingival index at baseline | 0.4927 units on a scale | Standard Deviation 0.3005 |
| Verbal Oral Hygiene Instructions | Change in Gingival Index | Gingival index after 4 weeks | 0.5941 units on a scale | Standard Deviation 0.5679 |
Comparison: The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.~The null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances.p-value: 0.0283Wilcoxon (Mann-Whitney)
p-value: 0.0002Wilcoxon (Mann-Whitney)
p-value: 0.4809Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: At baseline and after 4 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile Phone Application | Change in Plaque Index | Plaque index at baseline | 0.8050 units on a scale | Standard Deviation 0.4062 |
| Mobile Phone Application | Change in Plaque Index | Plaque index after 4 weeks | 0.6677 units on a scale | Standard Deviation 0.3146 |
| Verbal Oral Hygiene Instructions | Change in Plaque Index | Plaque index after 4 weeks | 0.9891 units on a scale | Standard Deviation 0.5244 |
| Verbal Oral Hygiene Instructions | Change in Plaque Index | Plaque index at baseline | 0.8959 units on a scale | Standard Deviation 0.4824 |
Comparison: The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.~The null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances.p-value: 0.0444Wilcoxon (Mann-Whitney)
p-value: 0.0002Wilcoxon (Mann-Whitney)
p-value: 0.0283Wilcoxon (Mann-Whitney)