- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05001490
Smartphone Application Based Reminder Therapy in Orthodontic Patients
Effectiveness of Smartphone Application Based Brushing Reminder Therapy for Plaque Control in Orthodontic Patients: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
KPK
-
Peshawar, KPK, Pakistan, 25100
- Rehman Medical Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: Experimental group
|
Brushing reminders were given to the patients in experimental group through a smartphone application twice daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plaque index score
Time Frame: 0 weeks ( at T0)
|
Turesky modified Quigley-Hein plaque index (score: minimum=0 maximum=5.
worsening with increase in score from 0-5)
|
0 weeks ( at T0)
|
|
Plaque index score
Time Frame: 2 weeks ( at T1)
|
Turesky modified Quigley-Hein plaque index (score: minimum=0 maximum=5.
worsening with increase in score from 0-5)
|
2 weeks ( at T1)
|
|
Plaque index score
Time Frame: 6 weeks (at T2)
|
Turesky modified Quigley-Hein plaque index (score: minimum=0 maximum=5.
worsening with increase in score from 0-5)
|
6 weeks (at T2)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Aneela Nausheen, FCPS, Rehman-MI
- Study Chair: Muhammad K Asif, PHD, Rehman-MI
Publications and helpful links
General Publications
- Zachrisson BU. Gingival condition associated with orthodontic treatment. II. Histologic findings. Angle Orthod. 1972 Oct;42(4):353-7. No abstract available.
- Parizi MT, Mohammadi TM, Afshar SK, Hajizamani A, Tayebi M. Efficacy of an electric toothbrush on plaque control compared to two manual toothbrushes. Int Dent J. 2011 Jun;61(3):131-5. doi: 10.1111/j.1875-595X.2011.00029.x.
- Eppright M, Shroff B, Best AM, Barcoma E, Lindauer SJ. Influence of active reminders on oral hygiene compliance in orthodontic patients. Angle Orthod. 2014 Mar;84(2):208-13. doi: 10.2319/062813-481.1. Epub 2013 Sep 12.
- Al-Jewair TS, Suri S, Tompson BD. Predictors of adolescent compliance with oral hygiene instructions during two-arch multibracket fixed orthodontic treatment. Angle Orthod. 2011 May;81(3):525-31. doi: 10.2319/092010-547.1. Epub 2011 Feb 9.
- Cozzani M, Ragazzini G, Delucchi A, Mutinelli S, Barreca C, Rinchuse DJ, Servetto R, Piras V. Oral hygiene compliance in orthodontic patients: a randomized controlled study on the effects of a post-treatment communication. Prog Orthod. 2016 Dec;17(1):41. doi: 10.1186/s40510-016-0154-9. Epub 2016 Dec 19.
- Erbe C, Klees V, Ferrari-Peron P, Ccahuana-Vasquez RA, Timm H, Grender J, Cunningham P, Adam R, Farrell S, Wehrbein H. A comparative assessment of plaque removal and toothbrushing compliance between a manual and an interactive power toothbrush among adolescents: a single-center, single-blind randomized controlled trial. BMC Oral Health. 2018 Aug 3;18(1):130. doi: 10.1186/s12903-018-0588-1.
- Cardoso Mde A, Saraiva PP, Maltagliati LA, Rhoden FK, Costa CC, Normando D, Capelozza Filho L. Alterations in plaque accumulation and gingival inflammation promoted by treatment with self-ligating and conventional orthodontic brackets. Dental Press J Orthod. 2015 Mar-Apr;20(2):35-41. doi: 10.1590/2176-9451.20.2.035-041.oar.
- McCarney R, Warner J, Iliffe S, van Haselen R, Griffin M, Fisher P. The Hawthorne Effect: a randomised, controlled trial. BMC Med Res Methodol. 2007 Jul 3;7:30. doi: 10.1186/1471-2288-7-30.
- Schwebel FJ, Larimer ME. Using text message reminders in health care services: A narrative literature review. Internet Interv. 2018 Jun 21;13:82-104. doi: 10.1016/j.invent.2018.06.002. eCollection 2018 Sep.
- Farhadifard H, Soheilifar S, Farhadian M, Kokabi H, Bakhshaei A. Orthodontic patients' oral hygiene compliance by utilizing a smartphone application (Brush DJ): a randomized clinical trial. BDJ Open. 2020 Nov 20;6(1):24. doi: 10.1038/s41405-020-00050-5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EC 2020-09-055
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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