Patient ComplianceNCT05331820
The Influence of Weekly Reminders on Enhancing Patient Compliance in Patients With Fixed Orthodontic Treatment
A study testing weekly mobile reminder in people with Patient Compliance, run by Shara Qadir Hussein at 1 site in Iraq.
Trial summary
this study is a randomized clinical trial to evaluate the effect of sending weekly reminders to patients undergoing fixed orthodontic appliance treatment. two groups will be formed and participants of the study will be divided between the two groups randomly. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Compliance
- What is being tested?
- weekly mobile reminder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIraq
- Study dates
- 28 Nov 2021to 1 Apr 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with a fixed orthodontic appliance
- both gender
- age 15-25 years old
- patient or parent have smartphone and internet connection
- malocclusion of the patient undergoing treatment according to Index of Orthodontic Treatment Need IOTN should be grade 1,2, and 3
- good gingival health.
Who cannot join
- Patients with a removable appliance
- cleft lip and palate patients
- patients with hypomineralization visible on anterior teeth
- susceptible to periodontal disease
- have diabetes
- handicap patients, a severe malocclusion above IOTN grade 3, ceramic brackets, and a child with parents that cannot read.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Reminder on Enhancing Patient Compliance in Patients With Fixed Orthodontic Appliance Treatment (a Randomized Controlled Clinical Trial)
this study is a randomized clinical trial to evaluate the effect of sending weekly reminders to patients undergoing fixed orthodontic appliance treatment. two groups will be formed and participants of the study will be divided between the two groups randomly. the intervention group will receive weekly reminders about the importance of oral hygiene and appliance care with adherence to scheduled appointments. the difference between these parameters will be evaluated between the control and intervention groups to describe the importance of weekly reminders to enhance the compliance and cooperation of the patient. the oral hygiene of the patient will include plaque level(plaque index), gingival statue level( bleeding index), and white spot lesion . appliance care will be recorded when in case of bracket failure and appointments missed will also be recorded .
- Conditions
- Patient Compliance
- Being tested
- weekly mobile reminder
- Keywords
- patient compliance, orthodontic patients, reminder
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weekly mobile reminderOther
a weekly reminder will be sent to participants in the intervention group via mobile internet applications
| Study group | Role | What they receive |
|---|---|---|
| standard care group | No intervention | this group of participants will be used to compare to the intervention group. normal and professional instructions and motivation will be given to them but they will not receive weekly reminders about the importance of adherence to instructions |
| weekly reminder group | Experimental | this group of participants will receive a weekly reminder about the importance of oral hygiene, appliance care, and adherence to recommendations from the dentist. Receives: Other: weekly mobile reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral hygiene examination The plaque index system
consists of 4 degree higher score is the worst situation and 0 is the best
Measured: during the intervention ( follow up for 6 months )
oral hygiene examination - Bleeding Index
bleeding on probing . conatains 3 scores 0 - no bleeding
- bleeding after 30 seconds
- bleeding immediately score 0 is the best and score 2 is the worst
Measured: during the intervention ( follow up for 6 months )
oral hygiene examination white spot lesion
white spot lesion on the tooth will be examined clinically and recorded in photographs
Measured: during the intervention ( follow up for 6 months )
appliance care
bracket failure will be recorded if there is any brackets/"
] bracket fracture will be recorded at appointments if there is any bracket dislodgments that needs replacement
Measured: during the intervention ( follow up for 6 months )
adherence to appointment
if patient does not come to the appointment it will be recorded as lack of adherence to appointments .
Measured: during the intervention ( follow up for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start28 Nov 2021
- Primary completion13 Mar 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patient ComplianceStudies 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shara Qadir Hussein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shara Qadir Hussein, University of Sulaimani
- Investigators
- Hadi M Ismail, as.professor, Principal investigator, University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331820
- Sponsor's protocol ID
- 1
- Status last verified
- Apr 2023
- First submitted
- 3 Dec 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The initial follow up period for this research is 6 months , if participants agree it may be increased to use in other research for longer follow up.
Publications
Mohammed H, Rizk MZ, Wafaie K, Ulhaq A, Almuzian M. Reminders improve oral hygiene and adherence to appointments in orthodontic patients: a systematic review and meta-analysis. Eur J Orthod. 2019 Mar 29;41(2):204-213. doi: 10.1093/ejo/cjy045.
PubMed 29947755Lima IFP, de Andrade Vieira W, de Macedo Bernardino I, Costa PA, Lima APB, Pithon MM, Paranhos LR. Influence of reminder therapy for controlling bacterial plaque in patients undergoing orthodontic treatment: A systematic review and meta-analysis. Angle Orthod. 2018 Jul;88(4):483-493. doi: 10.2319/111117-770.1. Epub 2018 Apr 17.
PubMed 29664334Hussein S, Ismail H. Influence of Reminder on Enhancing Compliance in Patients with Fixed Orthodontic Appliance Treatment (a Randomized Controlled Clinical Trial). Patient Prefer Adherence. 2023 Jul 20;17:1759-1769. doi: 10.2147/PPA.S418109. eCollection 2023.
PubMed 37492635
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Reminder on Enhancing Patient Compliance in Patients With Fixed Orthodontic Appliance Treatment (a Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05331820
- Acronym / sponsor ID
- 1
- Conditions
- Patient Compliance
- Keywords
- patient compliance, orthodontic patients, reminder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Shara Qadir HusseinUniversity, hospital or other
- Study start
- 28 Nov 2021 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 18 Apr 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.
this study is a randomized clinical trial to evaluate the effect of sending weekly reminders to patients undergoing fixed orthodontic appliance treatment. two groups will be formed and participants of the study will be divided between the two groups randomly. the intervention group will receive weekly reminders about the importance of oral hygiene and appliance care with adherence to scheduled appointments. the difference between these parameters will be evaluated between the control and intervention groups to describe the importance of weekly reminders to enhance the compliance and cooperation of the patient. the oral hygiene of the patient will include plaque level(plaque index), gingival statue level( bleeding index), and white spot lesion . appliance care will be recorded when in case of bracket failure and appointments missed will also be recorded .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care group | No intervention | –this group of participants will be used to compare to the intervention group. normal and professional instructions and motivation will be given to them but they will not receive weekly reminders about the importance of adherence to instructions |
| weekly reminder group | Experimental | Other: weekly mobile reminderthis group of participants will receive a weekly reminder about the importance of oral hygiene, appliance care, and adherence to recommendations from the dentist. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients with a fixed orthodontic appliance
- both gender
- age 15-25 years old
- patient or parent have smartphone and internet connection
- malocclusion of the patient undergoing treatment according to Index of Orthodontic Treatment Need IOTN should be grade 1,2, and 3
Key exclusion criteria (6 listed)
- Patients with a removable appliance
- cleft lip and palate patients
- patients with hypomineralization visible on anterior teeth
- susceptible to periodontal disease
- have diabetes
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 |
|---|---|---|
| weekly mobile remindera weekly reminder will be sent to participants in the intervention group via mobile internet applications | Other | weekly reminder group |
Primary outcome
oral hygiene examination The plaque index system
Time frame: during the intervention ( follow up for 6 months )
consists of 4 degree higher score is the worst situation and 0 is the best
oral hygiene examination - Bleeding Index
Time frame: during the intervention ( follow up for 6 months )
bleeding on probing . conatains 3 scores 0 - no bleeding 1. bleeding after 30 seconds 2. bleeding immediately score 0 is the best and score 2 is the worst
oral hygiene examination white spot lesion
Time frame: during the intervention ( follow up for 6 months )
white spot lesion on the tooth will be examined clinically and recorded in photographs
appliance care
Time frame: during the intervention ( follow up for 6 months )
bracket failure will be recorded if there is any brackets/" ] bracket fracture will be recorded at appointments if there is any bracket dislodgments that needs replacement
adherence to appointment
Time frame: during the intervention ( follow up for 6 months
if patient does not come to the appointment it will be recorded as lack of adherence to appointments .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Background: PubMed 29947755Mohammed H, Rizk MZ, Wafaie K, Ulhaq A, Almuzian M. Reminders improve oral hygiene and adherence to appointments in orthodontic patients: a systematic review and meta-analysis. Eur J Orthod. 2019 Mar 29;41(2):204-213. doi: 10.1093/ejo/cjy045.
- Background: PubMed 29664334Lima IFP, de Andrade Vieira W, de Macedo Bernardino I, Costa PA, Lima APB, Pithon MM, Paranhos LR. Influence of reminder therapy for controlling bacterial plaque in patients undergoing orthodontic treatment: A systematic review and meta-analysis. Angle Orthod. 2018 Jul;88(4):483-493. doi: 10.2319/111117-770.1. Epub 2018 Apr 17.
- Derived from this study: PubMed 37492635Hussein S, Ismail H. Influence of Reminder on Enhancing Compliance in Patients with Fixed Orthodontic Appliance Treatment (a Randomized Controlled Clinical Trial). Patient Prefer Adherence. 2023 Jul 20;17:1759-1769. doi: 10.2147/PPA.S418109. eCollection 2023.
- Individual participant dataSharing planned: No. The initial follow up period for this research is 6 months , if participants agree it may be increased to use in other research for longer follow up.
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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.
Hadi M Ismail, as.professor principal investigator
University of Sulaimani
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weekly mobile reminder in people with Patient Compliance, run by Shara Qadir Hussein at 1 site in Iraq.
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 6 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: finished, as of the sponsor's last update on 19 Apr 2023. 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 Iraq. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral hygiene examination The plaque index system (time frame: during the intervention ( follow up for 6 months )). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05331820, which also lists 3 linked publications.
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 19 Apr 2023.