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

NCT05527613 | Unknown

• 1 other identifier: Oral hygiene - WhatsApp
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Oral Hygiene; Mobiles Applications

Keywords

Mobiles Applications; Oral Hygiene; Orthodontic Appliances; Fixed; Treatment Outcome

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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

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

Secondary Outcomes (1)

• microbiological changes (microbiological composition of biofilm)

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

Study Arms (2)

Conventional bracket bonding with instructions by WhatsApp

EXPERIMENTAL

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

Conventional bracket bonding without instructions by whatsapp

ACTIVE COMPARATOR

receive verbal instructions on oral hygiene

Other: whatsapp application with oral hygiene reminder for orthodontic patients

Interventions

whatsapp application with oral hygiene reminder for orthodontic patients 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 with instructions by WhatsApp; Conventional bracket bonding without instructions by whatsapp

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fundación Universitaria CIEO: lead

Study Sites (1)

Fundación Universitaria CIEO -UniCIEO

Bogotá, Cundinamarca, 111111, Colombia

Location

Study Officials

• Claudia Ramirez

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rocio Duarte

CONTACT

3118248146; jr.duarte@unicieo.edu.co

Maria Gutierrez

CONTACT

3223120616; mf.gutierrez@uncieo.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: investigator

Model Details: consort scheme

Study Record Dates

• First Submitted: August 13, 2022
• First Posted: September 2, 2022
• Study Start: October 12, 2022
• Primary Completion: March 25, 2023
• Study Completion: September 30, 2023
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)