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

September 1, 2022 updated by: Claudia Mercedes Ramirez, Fundación Universitaria CIEO

Comparison of the Efficacy of a Messaging Application or Verbal Instructions to Improve Oral Hygiene in Patients With Fixed Orthodontic Treatment. Randomized Clinical Trial

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in oral hygiene (plaque index (OPI)
Time Frame: the OPI index will be measured over a three-month period
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.
the OPI index will be measured over a three-month period
Changes in oral hygiene (bleeding on probing index)
Time Frame: the bleeding on probing index will be measured over a three-month period
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
the bleeding on probing index will be measured over a three-month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
microbiological changes (microbiological composition of biofilm)
Time Frame: biofilm sample and microbiological study will be performed at the beginning and in the third month of the study
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.
biofilm sample and microbiological study will be performed at the beginning and in the third month of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Universitaria CIEO

Investigators

  • Principal Investigator: Claudia Ramirez

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 12, 2022

Primary Completion (Anticipated)

March 25, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

August 13, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

September 2, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Oral hygiene - WhatsApp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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