NCT05001490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

April 1, 2021

Last Update Submit

September 14, 2022

Conditions

Keywords

oral hygienesmartphone applicationplaque index

Outcome Measures

Primary Outcomes (3)

  • Plaque index score

    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

    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

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

    6 weeks (at T2)

Study Arms (2)

Experimental group

EXPERIMENTAL
Other: Smartphone application based reminder

Control group

NO INTERVENTION

Interventions

Brushing reminders were given to the patients in experimental group through a smartphone application twice daily

Also known as: Routine oral hygiene instructions
Experimental group

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehman medical institute

Peshawar, KPK, 25100, Pakistan

Location

Related Publications (10)

  • Zachrisson BU. Gingival condition associated with orthodontic treatment. II. Histologic findings. Angle Orthod. 1972 Oct;42(4):353-7. No abstract available.

    PMID: 4507151BACKGROUND
  • 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.

    PMID: 21692783BACKGROUND
  • 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.

    PMID: 24028316BACKGROUND
  • 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.

    PMID: 21306222BACKGROUND
  • 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.

    PMID: 27891568BACKGROUND
  • 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.

    PMID: 30075780BACKGROUND
  • 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 Officials

  • Aneela Nausheen, FCPS

    Rehman-MI

    STUDY CHAIR
  • Muhammad K Asif, PHD

    Rehman-MI

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident, department of orthodontics

Study Record Dates

First Submitted

April 1, 2021

First Posted

August 12, 2021

Study Start

August 1, 2020

Primary Completion

December 15, 2020

Study Completion

January 31, 2021

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations