Smartphone Application Based Reminder Therapy in Orthodontic Patients

Sponsor
Rehman Medical Institute - RMI (Other)
Overall Status
Completed
CT.gov ID
NCT05001490
Collaborator
(none)
60
1
2
6
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Smartphone application based reminder
N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Control TrialRandomized Control Trial
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Effectiveness of Smartphone Application Based Brushing Reminder Therapy for Plaque Control in Orthodontic Patients: A Randomized Controlled Trial
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
Dec 15, 2020
Actual Study Completion Date :
Jan 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

Other: Smartphone application based reminder
Brushing reminders were given to the patients in experimental group through a smartphone application twice daily
Other Names:
  • Routine oral hygiene instructions
  • No Intervention: Control group

    Outcome Measures

    Primary Outcome Measures

    1. Plaque index score [0 weeks ( at T0)]

      Turesky modified Quigley-Hein plaque index (score: minimum=0 maximum=5. worsening with increase in score from 0-5)

    2. Plaque index score [2 weeks ( at T1)]

      Turesky modified Quigley-Hein plaque index (score: minimum=0 maximum=5. worsening with increase in score from 0-5)

    3. Plaque index score [6 weeks (at T2)]

      Turesky modified Quigley-Hein plaque index (score: minimum=0 maximum=5. worsening with increase in score from 0-5)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rehman medical institute Peshawar KPK Pakistan 25100

    Sponsors and Collaborators

    • Rehman Medical Institute - RMI

    Investigators

    • Study Chair: Aneela Nausheen, FCPS, Rehman-MI
    • Study Chair: Muhammad K Asif, PHD, Rehman-MI

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Salman Khan, Resident, department of orthodontics, Rehman Medical Institute - RMI
    ClinicalTrials.gov Identifier:
    NCT05001490
    Other Study ID Numbers:
    • EC 2020-09-055
    First Posted:
    Aug 12, 2021
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Salman Khan, Resident, department of orthodontics, Rehman Medical Institute - RMI

    Study Results

    No Results Posted as of Sep 14, 2021