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

Oral Hygiene Clinical Trial

— EEMAOHOP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05527613
• Other study ID #: Oral hygiene - WhatsApp
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 12, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: September 2022
• Source: Fundación Universitaria CIEO
• Contact: Rocio Duarte
• Phone: 3118248146
• Email: jr.duarte[@]unicieo.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 30, 2023
• Est. primary completion date: March 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Oral Hygiene

Intervention

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

Locations

Country	Name	City	State
Colombia	Fundación Universitaria CIEO -UniCIEO	Bogotá	Cundinamarca

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Universitaria CIEO

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	biofilm sample and microbiological study will be performed at the beginning and in the third month of the study