Smartphone Application Based Reminder Therapy in Orthodontic Patients

Orthodontic Appliance Complication Clinical Trial

Official title:

Effectiveness of Smartphone Application Based Brushing Reminder Therapy for Plaque Control in Orthodontic Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05001490
• Other study ID #: EC 2020-09-055
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: September 2022
• Source: Rehman Medical Institute - RMI
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 31, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Orthodontic Appliance Complication

Intervention

Other:
• Smartphone application based reminder
Brushing reminders were given to the patients in experimental group through a smartphone application twice daily

Locations

Country	Name	City	State
Pakistan	Rehman medical institute	Peshawar	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Rehman Medical Institute - RMI

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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. — View Citation

Cardoso Mde A, Saraiva PP, Maltagliati LÁ, 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 Orth — View Citation

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. Epub 2016 Dec 19. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Zachrisson BU. Gingival condition associated with orthodontic treatment. II. Histologic findings. Angle Orthod. 1972 Oct;42(4):353-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)