Clinical trial NCT05001490: Smartphone Application Based Reminder Therapy in Orthodontic Patients
Official title: Effectiveness of Smartphone Application Based Brushing Reminder Therapy for Plaque Control in Orthodontic Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance Complication
Keywords: oral hygiene
smartphone application
plaque index
Lead sponsor: Rehman Medical Institute - RMI
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized control trial was performed to asses the efficiency of smartphone application based reminder therapy on plaque control and oral hygiene at two points in time.

Detailed description: This randomized controlled trial was performed to assess the effect of the smartphone application based reminders for oral hygiene reinforcement on orthodontic patients. Methods: 60 orthodontic patients were randomly allocated to either control or experimental group (30 each). Experimental groups received reminders twice a day by a smartphone application. Plaque scoring was done by using Turesky modified Quigley-Hein plaque index (TMQHPI) at baseline(T0), after 2 weeks(T1) and after 6 weeks(T3). Results: Significant difference in plaque scores was found at T2(6 weeks), but no significant difference was found at T1(2 weeks). Conclusions: Active smartphone-based reminder therapy for oral hygiene maintenance during fixed appliance orthodontic treatment decreases the plaque scores in patients in medium to long term

Eligibility criteria: Inclusion Criteria:

- A total of Sixty (60) patients between 12-30 years of age undergoing fixed appliance therapy were included in the study. All the participants had to be in at least 4 weeks of active orthodontic therapy with fixed appliances in all the quadrants of the oral cavity. Further inclusion criteria were familiarity with smartphone and a personal smartphone with Android version ≥ 6.0 or iOS version ≥ 10 operating system, good general and dental health (no active caries, no advanced gingivitis, or periodontitis needing periodontal therapy), with no history of smoking or any other form of tobacco use, no antibiotic or chlorhexidine containing mouth rinses used within two weeks of screening.

Exclusion Criteria:

- Patients with prosthesis in the mouth and those taking antibiotics, anti-epileptics, anti-hypertensives and immunosuppressive medications were excluded from the study.

Primary outcomes:
measure: Plaque index score
timeFrame: 0 weeks ( at T0)
measure: Plaque index score
timeFrame: 2 weeks ( at T1)
measure: Plaque index score
timeFrame: 6 weeks (at T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Rehman medical institute
state: KPK
Study officials:
affiliation: Rehman-MI
name: Aneela Nausheen, FCPS
role: STUDY_CHAIR
affiliation: Rehman-MI
name: Muhammad K Asif, PHD
role: STUDY_CHAIR
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