ClinicalTrials.gg
Status unknownNCT05527613EEMAOHOPUpdated Sep 2, 2022

Evaluation of the Efficacy of a Messaging Application to Improve Oral Hygiene in Orthodontic Patients.ECA

An interventional study of whatsapp application with oral hygiene reminder for orthodontic patients in Oral Hygiene and Mobiles Applications, sponsored by Fundación Universitaria CIEO. Status unknown at 1 site in Colombia. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-02.

Sponsored by Fundación Universitaria CIEO · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

The aim of this article was to compare the efficacy of a messaging application compared to verbal instructions for improving oral hygiene in patients undergoing fixed orthodontic treatment with conventional ligature brackets (MBT technique) over a 3-month period. Randomized clinical trial of two parallel groups with 1:1 allocation ratio. Conducted in the orthodontic postgraduate clinic of the conventional ligation technique (MBT) at the Fundación Universitaria CIEO- UniCIEO, Bogotá, Colombia.

Sixty patients aged 18 to 30 years with periodontal health and active WhatsApp application on smartphone, who started fixed orthodontic treatment with conventional ligation brackets (MBT technique) were included.

Randomization Intervention: all participants received verbal oral hygiene instructions, were randomly assigned by software to the mobile app group (GAM) (n=30) (mean-----DE---- years) that used WhatsApp to reinforce oral hygiene, or to the control group (CG) (n=30) (mean-----DE---- years).

The primary outcome was bacterial plaque level determined with the orthodontic plaque index (OPI) and bleeding on probing (BOP) index measured at three points, after appliance cementation (T0), 1 month later (T1), 2 months later (T2) and 3 months later (T3). Blinding: By two trained operators and blinded to the assignment. The secondary outcome was the identification of microorganisms in the bacterial plaque of the bracket ligation. The data were analyzed by

Read the detailed description

In this study the researchers are going to recruit patients from the orthodontic clinics with conventional ligation brackets of the MBT technique, from the CIEO - UniCIEO University Foundation; who receive a sequence of archwires, according to the phases of the treatment such as the initial alignment and leveling phase: Nickel - titanium archwires of caliber 0.014, 0.016. Patients entering the study will be randomly assigned to each of the groups; participants in group 1 will receive the WhatsApp application, and at the same time they will receive verbal instructions in oral hygiene; they will be sent reminders, through images and videos with necessary, accurate and instructive information; messages will be sent twice a week for three months. In group 2 the participants will receive verbal instructions given by the researcher on oral hygiene and a video with instructions on the important elements to perform oral hygiene in orthodontic patients. Two indices will also be evaluated: the orthodontic plaque index and the bleeding on probing index.

02

Conditions studied

  • Oral Hygiene
  • Mobiles Applications

Keywords

  • Mobiles Applications
  • Oral Hygiene
  • Orthodontic Appliances
  • Fixed
  • Treatment Outcome
03

In context

Lead sponsor

Fundación Universitaria CIEO is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Voluntarily agree to participate in the study.
  • Age from 18 to 30 years
  • Patients undergoing orthodontic treatment with fixed appliances using the MBT technique.
  • Periodontal health on intact periodontium or diminished periodontium with no history of periodontitis, no presence of bacterial plaque score 0 No plaque deposits on tooth surfaces surrounding the bracket base; according to OPI index, no presence of periodontal pockets, calculus, gingival inflammation and bleeding verified by the periodontist.
  • Have cell phone with active WhatsApp application and possibility to connect twice a week, verified by patient interview previously.
  • No kinship between participants (affinity/consanguinity)

Exclusion criteria

Exclusion Criteria:

  • Systemic history (diabetes, hypertension, poor nutrition), verified by previous patient interview.
  • Smokers (smoke 10 cigarettes per day), verified by previous patient interview.
  • Pregnancy and lactation.
  • Participating in another research or oral health education program.
  • Difficulty in speaking or writing Spanish.
  • Physical or mental limitation.
  • Diagnosis of SARS COV-2.
  • Use of mouthwash during the three months of the study.
  • Use of additional appliances (lingual arch, transpalatal bar, among others)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Conventional bracket bonding with instructions by WhatsApp

    will receive the WhatsApp application, through which oral hygiene reminders will be sent through images and videos with the necessary information, and at the same time they will receive verbal oral hygiene instructions

    Other: whatsapp application with oral hygiene reminder for orthodontic patients

  • Active comparator
    Conventional bracket bonding without instructions by whatsapp

    receive verbal instructions on oral hygiene

    Other: whatsapp application with oral hygiene reminder for orthodontic patients

Interventions

  • Otherwhatsapp application with oral hygiene reminder for orthodontic patients

    Participants with orthodontics will be randomly assigned to receive the WhatsApp application, through which oral hygiene reminders will be sent using images and videos containing necessary information, and at the same time they will receive verbal instructions on oral hygiene

06

What researchers measure

Primary outcomes

  1. Changes in oral hygiene (plaque index (OPI)

    It will be assessed by the orthodontic plaque index (OPI). The dentition is divided into sextants and the degree of plaque accumulation on each bracket surface (mesial, distal, gingival, incisal/occlusal) and the condition of the adjacent marginal gingivae is assessed. The OPI index is evaluated by four scores or grades; score 0 indicates absence of plaque and inflammation; scores 1 to 3 refer to the severity of plaque accumulations on adjacent brackets and score 4 includes the state of gingival inflammation.

    Time frame: the OPI index will be measured over a three-month period

  2. Changes in oral hygiene (bleeding on probing index)

    It will be measured by means of the bleeding index according to Loe and Silness. The teeth chosen to apply the gingival index are: 1.6, 2.1, 2.4, 3.6, 4.1, and 4.4, and they are applied in four sites per tooth: distal, vestibular, mesial, and palatal. This means that 24 measurements should be recorded for each patient. The average of the 24 measurements constitutes the Bleeding Index for the whole mouth. At grade 0, there is no bleeding, no bleeding on probing (wait 10 to 30 seconds); at grade 1, there is bleeding, bleeding on probing immediately

    Time frame: the bleeding on probing index will be measured over a three-month period

Secondary outcomes

  1. microbiological changes (microbiological composition of biofilm)

    The collection of supragingival microbial samples will be collected at the beginning (T0) of the study and at day 90 (T3), after recording the clinical parameters, an explorer will be used as an instrument to remove the elastie or ligature from the bracket and collect the sample from the plaque, which will then be transferred to a transport medium.

    Time frame: biofilm sample and microbiological study will be performed at the beginning and in the third month of the study

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05527613
Lead sponsor
Fundación Universitaria CIEO
Responsible party
Claudia Mercedes Ramirez (investigator, Fundación Universitaria CIEO) — Principal investigator
First posted
Sep 2, 2022
Start date
Oct 12, 2022 (estimated)
Primary completion
Mar 25, 2023 (estimated)
Completion
Sep 30, 2023 (estimated)
Last update
Sep 2, 2022

Study contacts

Rocio Duarte
Contact
jr.duarte@unicieo.edu.co
3118248146
Maria Gutierrez
Contact
mf.gutierrez@uncieo.edu.co
3223120616
Claudia Ramirez
principal investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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