Oral HygieneNCT03330535
The Effect of Active Reminders on Oral Hygiene in Orthodontics
A study testing Reminders once a week, Verbal oral hygiene instructions and Reminders three times a week in people with Oral Hygiene, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
Trial summary
The aim of this study is to investigate the efficacy of text message active reminders at different time intervals of oral hygiene instructions in patients with orthodontic fixed appliances. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene
- What is being tested?
- Reminders once a week, Verbal oral hygiene instructions and Reminders three times a week
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 May 2018to Dec 2019
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants were having orthodontic fixed appliance treatment.
- Participants were aged 12 years old and above, owned mobile phones and did not have mental or physical disabilities.
- Participants were willing to comply with given oral hygiene instructions.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Riyadh Elm University
Riyadh, Riyadh Region, 11681
Omar AlKadhi
About this study
Official title: The Effect of Active Reminders on Oral Hygiene of Patients With Fixed Orthodontic Appliances With Different Time Intervals
The aim of this study is to investigate the efficacy of text message active reminders at different time intervals of oral hygiene instructions in patients with orthodontic fixed appliances.
Read the detailed description
Participants with orthodontic fixed appliances will be recruited from the university hospital clinics to receive text message reminders of oral hygiene. Four groups of participants will be formulated. Group 1 will be the control group and will not receive text messages. Group 2 will receive messages once a week. Group 3 will receive text message reminders 3 times a week. Group 4 will receive daily reminders. At baseline, after 4 weeks and after 8 weeks, gingival index and plaque index will be measured at each time point and then compared between groups.
- Conditions
- Oral Hygiene
- Being tested
- Reminders once a week, Verbal oral hygiene instructions, Reminders three times a week, Daily reminders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminders once a weekBehavioural
Participants in this group will receive active oral hygiene reminders through text messaging once a week.
Verbal oral hygiene instructionsBehavioural
Participants in this group will receive verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.
Reminders three times a weekBehavioural
Participants in this group will receive active oral hygiene reminders through text messaging three times a week.
Daily remindersBehavioural
Participants in this group will receive active oral hygiene reminders through text messaging on a daily basis.
| Study group | Role | What they receive |
|---|---|---|
| Verbal oral hygiene instructions | Active comparator | Participants will receive verbal oral hygiene instructions during routine orthodontic visits. Receives: Behavioral: Verbal oral hygiene instructions |
| Reminders once a week | Experimental | Participants will receive active reminders once a week. Receives: Behavioral: Reminders once a week |
| Reminders three times a week | Experimental | Participants will receive active reminders three times a week. Receives: Behavioral: Reminders three times a week |
| Daily reminders | Experimental | Participants will receive active reminders daily. Receives: Behavioral: Daily reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plaque Index
Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque.
Measured: At baseline, 4 weeks and 8 weeks
Change in gingival index
Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding.
Measured: At baseline, 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 May 2018
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (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
- Four groups of participants will be formulated. Each will will receive messages in different time interval starting from none, once a week, three times a week and daily.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Alkadhi, Riyadh Colleges of Dentistry and Pharmacy
- Investigators
- Omar H Alkadhi, BDS,MS, Principal investigator, Riyadh Colleges of Dentistry and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330535
- Sponsor's protocol ID
- FRP/2018/27
- Status last verified
- Dec 2018
- First submitted
- 31 Oct 2017
- Last updated
- 31 Dec 2018
- 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 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Active Reminders on Oral Hygiene of Patients With Fixed Orthodontic Appliances With Different Time Intervals
- ClinicalTrials.gov ID
- NCT03330535
- Acronym / sponsor ID
- FRP/2018/27
- Conditions
- Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Nov 2017 (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 study is to investigate the efficacy of text message active reminders at different time intervals of oral hygiene instructions in patients with orthodontic fixed appliances.
Detailed description
Participants with orthodontic fixed appliances will be recruited from the university hospital clinics to receive text message reminders of oral hygiene. Four groups of participants will be formulated. Group 1 will be the control group and will not receive text messages. Group 2 will receive messages once a week. Group 3 will receive text message reminders 3 times a week. Group 4 will receive daily reminders. At baseline, after 4 weeks and after 8 weeks, gingival index and plaque index will be measured at each time point and then compared between groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Four groups of participants will be formulated. Each will will receive messages in different time interval starting from none, once a week, three times a week and daily.
| Arm | Type | Receives |
|---|---|---|
| Verbal oral hygiene instructions | Active comparator | Behavioral: Verbal oral hygiene instructionsParticipants will receive verbal oral hygiene instructions during routine orthodontic visits. |
| Reminders once a week | Experimental | Behavioral: Reminders once a weekParticipants will receive active reminders once a week. |
| Reminders three times a week | Experimental | Behavioral: Reminders three times a weekParticipants will receive active reminders three times a week. |
| Daily reminders | Experimental | Behavioral: Daily remindersParticipants will receive active reminders daily. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants were having orthodontic fixed appliance treatment.
- Participants were aged 12 years old and above, owned mobile phones and did not have mental or physical disabilities.
- Participants were willing to comply with given oral hygiene instructions.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Reminders once a weekParticipants in this group will receive active oral hygiene reminders through text messaging once a week. | Behavioural | Reminders once a week |
| Verbal oral hygiene instructionsParticipants in this group will receive verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks. | Behavioural | Verbal oral hygiene instructions |
| Reminders three times a weekParticipants in this group will receive active oral hygiene reminders through text messaging three times a week. | Behavioural | Reminders three times a week |
| Daily remindersParticipants in this group will receive active oral hygiene reminders through text messaging on a daily basis. | Behavioural | Daily reminders |
Primary outcome
Change in Plaque Index
Time frame: At baseline, 4 weeks and 8 weeks
Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque.
Change in gingival index
Time frame: At baseline, 4 weeks and 8 weeks
Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Omar H Alkadhi, BDS,MS principal investigator
Riyadh Colleges of Dentistry and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminders once a week, Verbal oral hygiene instructions and Reminders three times a week in people with Oral Hygiene, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
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 3 inclusion and 0 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 31 Dec 2018. 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 Saudi Arabia. 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 Omar H Alkadhi, BDS,MS (966505154754, omar.alkadhi@riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plaque Index (time frame: At baseline, 4 weeks and 8 weeks). 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 31 Dec 2018.