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Orthodontic Appliance ComplicationNCT05001490

Smartphone Application Based Reminder Therapy in Orthodontic Patients

A study testing Smartphone application based reminder in people with Orthodontic Appliance Complication, run by Rehman Medical Institute - RMI at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 12 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Orthodontic Appliance Complication
What is being tested?
Smartphone application based reminder
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePakistan
Study dates
1 Aug 2020to 31 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Rehman medical institute

    Peshawar, KPK, 25100

Other trials in Pakistan

About this study

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

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.

Read the 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

Being tested
Smartphone application based reminder
Keywords
oral hygiene, smartphone application, plaque index

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smartphone application based reminderOther

    Also called Routine oral hygiene instructions

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

Study groups in NCT05001490
Study groupRoleWhat they receive
Experimental groupExperimentalNot described
Receives: Other: Smartphone application based reminder
Control groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plaque index score

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

    Measured: 0 weeks ( at T0)

  2. Plaque index score

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

    Measured: 2 weeks ( at T1)

  3. Plaque index score

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

    Measured: 6 weeks (at T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start1 Aug 2020
  3. Primary completion15 Dec 2020
  4. Study completion31 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Control Trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05001490
Sponsor's protocol ID
EC 2020-09-055
Status last verified
Sep 2022
First submitted
1 Apr 2021
Last updated
16 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 4507151

  • 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.

    PubMed 21692783

  • 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.

    PubMed 24028316

  • 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.

    PubMed 21306222

  • 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.

    PubMed 27891568

  • 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.

    PubMed 30075780

  • 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.

    PubMed 25992985

  • 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.

    PubMed 17608932

  • 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.

    PubMed 30206523

  • 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.

    PubMed 33298841

Questions about this trial

What is this clinical trial studying?

A study testing Smartphone application based reminder in people with Orthodontic Appliance Complication, run by Rehman Medical Institute - RMI at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plaque index score (time frame: 0 weeks ( at T0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05001490, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.

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