Oral HygieneEEMAOHOPNCT05527613
Evaluation of the Efficacy of a Messaging Application to Improve Oral Hygiene in Orthodontic Patients.ECA
A study testing whatsapp application with oral hygiene reminder for orthodontic patients in people with Oral Hygiene and Mobiles Applications, run by Fundación Universitaria CIEO at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene, Mobiles Applications
- What is being tested?
- whatsapp application with oral hygiene reminder for orthodontic patients
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteColombia
- Study dates
- 12 Oct 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación Universitaria CIEO -UniCIEO
Bogotá, Cundinamarca, 111111
Maria Gutierrez, 3223120616, mf.gutierrez@unicieo.edu.co
Rocio Duarte, 3118248146, jr.duarte@unicieo.edu.co
About this study
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
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.
Read more
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
Read the 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.
- Conditions
- Oral Hygiene, Mobiles Applications
- Being tested
- whatsapp application with oral hygiene reminder for orthodontic patients
- Keywords
- Mobiles Applications, Oral Hygiene, Orthodontic Appliances, Fixed, Treatment Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whatsapp application with oral hygiene reminder for orthodontic patientsOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: whatsapp application with oral hygiene reminder for orthodontic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: the bleeding on probing index will be measured over a three-month period
Secondary outcomes (1)
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.
Measured: biofilm sample and microbiological study will be performed at the beginning and in the third month of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start12 Oct 2022 (estimated)
- Primary completion25 Mar 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- consort scheme
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria CIEO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Mercedes Ramirez, Fundación Universitaria CIEO
- Investigators
- Claudia Ramirez, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527613
- Sponsor's protocol ID
- Oral hygiene - WhatsApp
- Acronym
- EEMAOHOP
- Status last verified
- Sep 2022
- First submitted
- 13 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05527613
- Acronym / sponsor ID
- EEMAOHOP / Oral hygiene - WhatsApp
- Conditions
- Oral Hygiene, Mobiles Applications
- Keywords
- Mobiles Applications, Oral Hygiene, Orthodontic Appliances, Fixed, Treatment Outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundación Universitaria CIEOUniversity, hospital or other
- Study start
- 12 Oct 2022 (estimated)
- Primary completion
- 25 Mar 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- consort scheme
| Arm | Type | Receives |
|---|---|---|
| Conventional bracket bonding with instructions by WhatsApp | Experimental | Other: whatsapp application with oral hygiene reminder for orthodontic patientswill 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 |
| Conventional bracket bonding without instructions by whatsapp | Active comparator | Other: whatsapp application with oral hygiene reminder for orthodontic patientsreceive verbal instructions on oral hygiene |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whatsapp application with oral hygiene reminder for orthodontic patientsParticipants 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 | Other | Conventional bracket bonding with instructions by WhatsApp, Conventional bracket bonding without instructions by whatsapp |
Primary outcome
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.
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Oral Hygiene
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Not yet recruiting
Game-based Oral Health Promotion
Oral Hygiene
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Ramirez principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whatsapp application with oral hygiene reminder for orthodontic patients in people with Oral Hygiene and Mobiles Applications, run by Fundación Universitaria CIEO at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rocio Duarte (3118248146, jr.duarte@unicieo.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in oral hygiene (plaque index (OPI) (time frame: the OPI index will be measured over a three-month period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.