Oral HygieneNCT06811688
Effectiveness of Mobile Phone Reminder Applications in Improving Oral Hygiene Compliance of Orthodontic Patients
A study testing Two mobile applications: Brushout and Brush teeth reminder applications in people with Oral Hygiene, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
The aim of this Randomized Controlled Trial (RCT) was to investigate the effectiveness of mobile application as an active reminder for improving oral hygiene compliance of patients undergoing orthodontic treatment using fixed orthodontic appliances. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene
- What is being tested?
- Two mobile applications: Brushout and Brush teeth reminder applications
- 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 siteSaudi Arabia
- Study dates
- 14 Feb 2023to 31 Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1- Subjects having orthodontic treatment using fixed appliances
- 2- The use of a smartphone to download Brushout app and Brush teeth reminder app
Who cannot join
- Subjects having orthodontic treatment using removable appliances
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Umm Al-Qura University, Dental Teaching Hospital
Mecca
About this study
Official title: The Effectiveness of Mobile Phone Reminders in the Improvement of Oral Hygiene in Patients With Fixed Orthodontic Appliances: A Randomized Controlled Trial
The aim of this Randomized Controlled Trial (RCT) was to investigate the effectiveness of mobile application as an active reminder for improving oral hygiene compliance of patients undergoing orthodontic treatment using fixed orthodontic appliances.
Read the detailed description
eligible participants will be randomly assigned to either control or intervention group. Group l (control): Only verbal instructions on oral hygiene including brushing using soft bristles, brushing for 2 minutes, flossing once daily, the use of fluoridated oral rinse, orthodontic appliance care and avoiding hard and sticky food.These instructions were given at the baseline visit. Then, these subjects were re-examined after 4 weeks. Group II (intervention): the subjects received the same oral hygiene instructions that were described to the control group with the addition of downloading two mobile applications: Brushout app and Brush teeth reminder app. These applications were adjusted to send notifications twice daily in the morning and night as reminders to practice oral hygiene. In addition, oral hygiene practice was tracked by a link that was sent electronically and checked by study researchers as a compliance protocol. Like the control group, subjects were re-examined after 4 weeks.
- Conditions
- Oral Hygiene
- Being tested
- Two mobile applications: Brushout and Brush teeth reminder applications
- Keywords
- Active reminders, Mobile application, Oral hygiene, Orthodontic fixed appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two mobile applications: Brushout and Brush teeth reminder applicationsOther
Also called reminder applications, mobile applications, smartphone application
These applications were adjusted to send notifications twice daily in the morning and night as reminders to practice oral hygiene.
| Study group | Role | What they receive |
|---|---|---|
| Verbal oral hygiene instructions group | No intervention | Only verbal instructions on oral hygiene including brushing using soft bristles, brushing for 2 minutes, flossing once daily, the use of fluoridated oral rinse, orthodontic appliance care and avoiding hard and sticky food. These instructions were given at the baseline visit. Then, these subjects were re-examined after 4 weeks |
| Smartphone reminder application group | Experimental | the subjects received the same oral hygiene instructions that were described to the control group with the addition of downloading two mobile applications: Brushout app and Brush teeth reminder app. These applications were adjusted to send notifications twice daily in the morning and night as reminders to practice oral hygiene. In addition, oral hygiene practice was tracked by a link that was sent electronically and checked by study researchers as a compliance protocol. Like the control group, subjects were re-examined after 4 weeks. Receives: Other: Two mobile applications: Brushout and Brush teeth reminder applications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index
As described by Silness-Löe plaque index, Six teeth (#16, #12, #24, #36, #32, #44) were used to evaluate the plaque present in each surface including facial, lingual, mesial and distal surface. The thickness of the plaque was measured as follows: 0: absence of microbial plaque, 1: thin film of microbial plaque along the free gingival margin, 2: moderate accumulation with plaque in sulcus, 3: large amount of plaque in sulcus or pocket along the free gingival margin.
Measured: At baseline and 4 weeks
Gingival index
Gingival index was used to evaluate the gingival condition in each surface including facial, lingual, mesial and distal. The following scores were used: 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 and tendency to spontaneous bleeding, ulceration.
Measured: At baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start14 Feb 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- The participants were asked to download two mobile applications: Brushout and Brush teeth reminder applications. These applications were adjusted to send notifications twice daily in the morning and night as reminders to practice oral hygiene.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahinaz N. Sembawa, Umm Al-Qura University
- Investigators
- Shahinaz N Sembawa, PhD, Principal investigator, Umm AlQura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811688
- Sponsor's protocol ID
- HAPO-02-K-012-2023-02-1459
- Other IDs
- +966125270000
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jepsen K, Sculean A, Jepsen S. Complications and treatment errors involving periodontal tissues related to orthodontic therapy. Periodontol 2000. 2023 Jun;92(1):135-158. doi: 10.1111/prd.12484. Epub 2023 Mar 15.
PubMed 36920050Santonocito S, Polizzi A. Oral Microbiota Changes during Orthodontic Treatment. Front Biosci (Elite Ed). 2022 Jul 27;14(3):19. doi: 10.31083/j.fbe1403019.
PubMed 36137992Patil S, Hedad IA, Jafer AA, Abutaleb GK, Arishi TM, Arishi SA, Arishi HA, Jafer M, Gujar AN, Khan S, Raj AT. Effectiveness of mobile phone applications in improving oral hygiene care and outcomes in orthodontic patients. J Oral Biol Craniofac Res. 2021 Jan-Mar;11(1):26-32. doi: 10.1016/j.jobcr.2020.11.004. Epub 2020 Nov 17.
PubMed 33344158Pascadopoli M, Zampetti P, Nardi MG, Pellegrini M, Scribante A. Smartphone Applications in Dentistry: A Scoping Review. Dent J (Basel). 2023 Oct 20;11(10):243. doi: 10.3390/dj11100243.
PubMed 37886928
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Mobile Phone Reminders in the Improvement of Oral Hygiene in Patients With Fixed Orthodontic Appliances: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06811688
- Acronym / sponsor ID
- HAPO-02-K-012-2023-02-1459
- Conditions
- Oral Hygiene
- Keywords
- Active reminders, Mobile application, Oral hygiene, Orthodontic fixed appliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 6 Feb 2025 (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 Randomized Controlled Trial (RCT) was to investigate the effectiveness of mobile application as an active reminder for improving oral hygiene compliance of patients undergoing orthodontic treatment using fixed orthodontic appliances.
Detailed description
eligible participants will be randomly assigned to either control or intervention group. Group l (control): Only verbal instructions on oral hygiene including brushing using soft bristles, brushing for 2 minutes, flossing once daily, the use of fluoridated oral rinse, orthodontic appliance care and avoiding hard and sticky food.These instructions were given at the baseline visit. Then, these subjects were re-examined after 4 weeks. Group II (intervention): the subjects received the same oral hygiene instructions that were described to the control group with the addition of downloading two mobile applications: Brushout app and Brush teeth reminder app. These applications were adjusted to send notifications twice daily in the morning and night as reminders to practice oral hygiene. In addition, oral hygiene practice was tracked by a link that was sent electronically and checked by study researchers as a compliance protocol. Like the control group, subjects were re-examined after 4 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The participants were asked to download two mobile applications: Brushout and Brush teeth reminder applications. These applications were adjusted to send notifications twice daily in the morning and night as reminders to practice oral hygiene.
| Arm | Type | Receives |
|---|---|---|
| Verbal oral hygiene instructions group | No intervention | –Only verbal instructions on oral hygiene including brushing using soft bristles, brushing for 2 minutes, flossing once daily, the use of fluoridated oral rinse, orthodontic appliance care and avoiding hard and sticky food. These instructions were given at the baseline visit. Then, these subjects were re-examined after 4 weeks |
| Smartphone reminder application group | Experimental | Other: Two mobile applications: Brushout and Brush teeth reminder applicationsthe subjects received the same oral hygiene instructions that were described to the control group with the addition of downloading two mobile applications: Brushout app and Brush teeth reminder app. These applications were adjusted to send notifications twice daily in the morning and night as reminders to practice oral hygiene. In addition, oral hygiene practice was tracked by a link that was sent electronically and checked by study researchers as a compliance protocol. Like the control group, subjects were re-examined after 4 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 1- Subjects having orthodontic treatment using fixed appliances
- 2- The use of a smartphone to download Brushout app and Brush teeth reminder app
Key exclusion criteria (1 listed)
- Subjects having orthodontic treatment using removable appliances
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 |
|---|---|---|
| Two mobile applications: Brushout and Brush teeth reminder applicationsAlso: reminder applications, mobile applications, smartphone applicationThese applications were adjusted to send notifications twice daily in the morning and night as reminders to practice oral hygiene. | Other | Smartphone reminder application group |
Primary outcome
Plaque Index
Time frame: At baseline and 4 weeks
As described by Silness-Löe plaque index, Six teeth (#16, #12, #24, #36, #32, #44) were used to evaluate the plaque present in each surface including facial, lingual, mesial and distal surface. The thickness of the plaque was measured as follows: 0: absence of microbial plaque, 1: thin film of microbial plaque along the free gingival margin, 2: moderate accumulation with plaque in sulcus, 3: large amount of plaque in sulcus or pocket along the free gingival margin.
Gingival index
Time frame: At baseline and 4 weeks
Gingival index was used to evaluate the gingival condition in each surface including facial, lingual, mesial and distal. The following scores were used: 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 and tendency to spontaneous bleeding, ulceration.
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 6 Feb 2025.
- Background: PubMed 36920050Jepsen K, Sculean A, Jepsen S. Complications and treatment errors involving periodontal tissues related to orthodontic therapy. Periodontol 2000. 2023 Jun;92(1):135-158. doi: 10.1111/prd.12484. Epub 2023 Mar 15.
- Background: PubMed 36137992Santonocito S, Polizzi A. Oral Microbiota Changes during Orthodontic Treatment. Front Biosci (Elite Ed). 2022 Jul 27;14(3):19. doi: 10.31083/j.fbe1403019.
- Background: PubMed 33344158Patil S, Hedad IA, Jafer AA, Abutaleb GK, Arishi TM, Arishi SA, Arishi HA, Jafer M, Gujar AN, Khan S, Raj AT. Effectiveness of mobile phone applications in improving oral hygiene care and outcomes in orthodontic patients. J Oral Biol Craniofac Res. 2021 Jan-Mar;11(1):26-32. doi: 10.1016/j.jobcr.2020.11.004. Epub 2020 Nov 17.
- Background: PubMed 37886928Pascadopoli M, Zampetti P, Nardi MG, Pellegrini M, Scribante A. Smartphone Applications in Dentistry: A Scoping Review. Dent J (Basel). 2023 Oct 20;11(10):243. doi: 10.3390/dj11100243.
- 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.
Shahinaz N Sembawa, PhD principal investigator
Umm AlQura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two mobile applications: Brushout and Brush teeth reminder applications in people with Oral Hygiene, run by Umm Al-Qura University 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 2 inclusion and 1 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 6 Feb 2025. 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?
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?
Plaque Index (time frame: At baseline and 4 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?
On the ClinicalTrials.gov record for NCT06811688, which also lists 4 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 6 Feb 2025.