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

NCT ID: NCT05527613

Last Updated: 2022-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-12

Study Completion Date

2023-09-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Oral Hygiene Mobiles Applications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

consort scheme
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
It is not possible to blind the interventions to the patients, nor to the clinicians performing the orthodontic treatment, however the operators, should not know the assignment of the study participants, the processing of the microbiological samples and the statistical advisor will also be blinded, this will be done by means of codes for each group.

Study Groups

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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

Group Type EXPERIMENTAL

whatsapp application with oral hygiene reminder for orthodontic patients

Intervention Type OTHER

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

Conventional bracket bonding without instructions by whatsapp

receive verbal instructions on oral hygiene

Group Type ACTIVE_COMPARATOR

whatsapp application with oral hygiene reminder for orthodontic patients

Intervention Type OTHER

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

Interventions

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whatsapp 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

Intervention Type OTHER

Eligibility Criteria

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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

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundación Universitaria CIEO

OTHER

Sponsor Role lead

Responsible Party

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Claudia Mercedes Ramirez

investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Ramirez

Role: PRINCIPAL_INVESTIGATOR

Locations

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Fundación Universitaria CIEO -UniCIEO

Bogotá, Cundinamarca, Colombia

Site Status

Countries

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Colombia

Central Contacts

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Rocio Duarte

Role: CONTACT

3118248146

Maria Gutierrez

Role: CONTACT

3223120616

Facility Contacts

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Maria Gutierrez

Role: primary

3223120616

Rocio Duarte

Role: backup

3118248146

Other Identifiers

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Oral hygiene - WhatsApp

Identifier Type: -

Identifier Source: org_study_id

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