EEMAOHOP
Comparison of the Efficacy of a Messaging Application or Verbal Instructions to Improve Oral Hygiene in Patients With Fixed Orthodontic Treatment. Randomized Clinical Trial
Sponsor study identifier
interventional
60
1 country
1
Study Start
October 12, 2022
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Primary Completion
March 25, 2023
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Study Completion
September 30, 2023
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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
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September 30, 2023
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 13, 2022
Actual (reported)September 2, 2022
Actual (reported)October 12, 2022
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March 25, 2023
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September 30, 2023
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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
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
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
receive verbal instructions on oral hygiene
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
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Fundación Universitaria CIEO -UniCIEO
Bogotá, Cundinamarca, 111111, Colombia
Claudia Ramirez
First Submitted
August 13, 2022
First Posted
September 2, 2022
Study Start
October 12, 2022
Estimated (date passed)Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 25, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 2, 2022
Record last verified: 2022-09
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