Oral Hygiene Education MethodsNCT06865625
Smartphone App Impact on Oral Hygiene in Orthodontics
An observational study of Oral Hygiene Education Methods, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare changes in gingival index (GI), plaque index (PI), and gingival bleeding index (GBI) values in fixed orthodontic patients. Participants were classified into two groups based on their oral hygiene: those using the Dentabuddy app for oral hygiene improvement and those receiving assistant-led… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene Education Methods
- What is being tested?
- mobile application and traditional oral hygiene motivation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Aug 2023to 3 Nov 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Faculty of Dentistry
Who may be able to join
- no missing teeth,
- no systemic diseases or medications,
- complete permanent dentition,
- ability to maintain personal oral hygiene
Who cannot join
- dental treatment affecting oral hygiene
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University
Konya, Meram, 42090
About this study
Official title: The Effect of Using a Smart Phone App on Oral Hygiene and Brushing Training During Fixed Orthodontic Therapy
This study aimed to compare changes in gingival index (GI), plaque index (PI), and gingival bleeding index (GBI) values in fixed orthodontic patients. Participants were classified into two groups based on their oral hygiene: those using the Dentabuddy app for oral hygiene improvement and those receiving assistant-led toothbrushing training.
Will the use of the Dentabuddy application lead to differences in oral hygiene levels? Can adolescents effectively utilize the program? Participants will compare the effectiveness of the smartphone application with a group receiving traditional oral hygiene motivation.
Read more
Participants:
Will use the program according to the designated time intervals. Will attend their appointments regularly.
Read the detailed description
The Dentabuddy application is a free oral hygiene improvement tool available for download on the Google Play Store. This study will include 60 patients aged 12-18 years who have been undergoing fixed orthodontic treatment for at least six months. Patients will be classified into good, fair, and poor oral hygiene groups based on the Simplified Oral Hygiene Index (OHI-S), assessed by the second researcher. Using the Research Randomizer website, participants will be randomly assigned to either the Dentabuddy group or the assistant-supported training group.
Gingival Index (GI), Plaque Index (PI), and Gingival Bleeding Index (GBI) values will be recorded at baseline, after one month, and after three months. These data will be compared between groups. Additionally, at the end of three months, participants will be asked to demonstrate the brushing technique they were taught using a bracketed model. Those meeting specific criteria will be classified as having successfully demonstrated the brushing technique.
- Conditions
- Oral Hygiene Education Methods
- Being tested
- mobile application, traditional oral hygiene motivation
- Keywords
- mobile application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile applicationBehavioural
In this study, unlike similar studies in the literature, participants were grouped based on their oral hygiene status.
traditional oral hygiene motivationBehavioural
The group demonstrating the brushing technique on a braces model
| Study group | Role | What they receive |
|---|---|---|
| Dentabuddy Group with good oral hygiene | Individuals with good oral hygiene receiving oral hygiene education through the Dentabuddy application. Receives: Behavioral: mobile application | |
| Dentabuddy Group with fair oral hygiene | Individuals with fair oral hygiene receiving oral hygiene education through the Dentabuddy application. Receives: Behavioral: mobile application | |
| Dentabuddy Group with poor oral hygiene | Individuals with poor oral hygiene receiving oral hygiene education through the Dentabuddy application. Receives: Behavioral: mobile application | |
| Assistant based trainning with good oral hygiene Group | Individuals with good oral hygiene receiving oral hygiene education through traditional methods. Receives: Behavioral: traditional oral hygiene motivation | |
| Assistant based trainning with fair oral hygiene Group | Individuals with fair oral hygiene receiving oral hygiene education through traditional methods. Receives: Behavioral: traditional oral hygiene motivation | |
| Assistant based trainning with poor oral hygiene Group | Individuals with poor oral hygiene receiving oral hygiene education through traditional methods. Receives: Behavioral: traditional oral hygiene motivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral hygiene in patients undergoing fixed orthodontic treatment
Participants whose oral hygiene scores are monitored through the use of the Dentabuddy application.
The Gingival Index (GI) and Plaque Index (PI) are assessed on four surfaces of each tooth (mesial, distal, buccal/labial, and lingual) using a scale from 0 to 3. The total score from all evaluated sites is summed and divided by the total number of teeth to obtain the mean GI and PI values. A reduction in values will indicate a positive outcome of the study.
Measured: From August to November 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start3 Aug 2023
- Primary completion3 Sep 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Hygiene Education MethodsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Sağoğlu, Konya Necmettin Erbakan Üniversitesi
- Investigators
- Seda Sağoğlu, Research Assistant, Principal investigator, Konya Necmettin Erbaka University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865625
- Sponsor's protocol ID
- 2023/319
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zotti F, Dalessandri D, Salgarello S, Piancino M, Bonetti S, Visconti L, Paganelli C. Usefulness of an app in improving oral hygiene compliance in adolescent orthodontic patients. Angle Orthod. 2016 Jan;86(1):101-7. doi: 10.2319/010915-19.1. Epub 2015 Mar 23.
PubMed 25799001
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using a Smart Phone App on Oral Hygiene and Brushing Training During Fixed Orthodontic Therapy
- ClinicalTrials.gov ID
- NCT06865625
- Acronym / sponsor ID
- 2023/319
- Conditions
- Oral Hygiene Education Methods
- Keywords
- mobile application
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 3 Sep 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 10 Mar 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.
This study aimed to compare changes in gingival index (GI), plaque index (PI), and gingival bleeding index (GBI) values in fixed orthodontic patients. Participants were classified into two groups based on their oral hygiene: those using the Dentabuddy app for oral hygiene improvement and those receiving assistant-led toothbrushing training.
Will the use of the Dentabuddy application lead to differences in oral hygiene levels? Can adolescents effectively utilize the program? Participants will compare the effectiveness of the smartphone application with a group receiving traditional oral hygiene motivation.
Participants:
Will use the program according to the designated time intervals. Will attend their appointments regularly.
Detailed description
The Dentabuddy application is a free oral hygiene improvement tool available for download on the Google Play Store. This study will include 60 patients aged 12-18 years who have been undergoing fixed orthodontic treatment for at least six months. Patients will be classified into good, fair, and poor oral hygiene groups based on the Simplified Oral Hygiene Index (OHI-S), assessed by the second researcher. Using the Research Randomizer website, participants will be randomly assigned to either the Dentabuddy group or the assistant-supported training group.
Gingival Index (GI), Plaque Index (PI), and Gingival Bleeding Index (GBI) values will be recorded at baseline, after one month, and after three months. These data will be compared between groups. Additionally, at the end of three months, participants will be asked to demonstrate the brushing technique they were taught using a bracketed model. Those meeting specific criteria will be classified as having successfully demonstrated the brushing technique.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dentabuddy Group with good oral hygiene | – | Behavioral: mobile applicationIndividuals with good oral hygiene receiving oral hygiene education through the Dentabuddy application. |
| Dentabuddy Group with fair oral hygiene | – | Behavioral: mobile applicationIndividuals with fair oral hygiene receiving oral hygiene education through the Dentabuddy application. |
| Dentabuddy Group with poor oral hygiene | – | Behavioral: mobile applicationIndividuals with poor oral hygiene receiving oral hygiene education through the Dentabuddy application. |
| Assistant based trainning with good oral hygiene Group | – | Behavioral: traditional oral hygiene motivationIndividuals with good oral hygiene receiving oral hygiene education through traditional methods. |
| Assistant based trainning with fair oral hygiene Group | – | Behavioral: traditional oral hygiene motivationIndividuals with fair oral hygiene receiving oral hygiene education through traditional methods. |
| Assistant based trainning with poor oral hygiene Group | – | Behavioral: traditional oral hygiene motivationIndividuals with poor oral hygiene receiving oral hygiene education through traditional methods. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Faculty of Dentistry
Key inclusion criteria (4 listed)
- no missing teeth,
- no systemic diseases or medications,
- complete permanent dentition,
- ability to maintain personal oral hygiene
Key exclusion criteria (1 listed)
- dental treatment affecting oral hygiene
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 |
|---|---|---|
| mobile applicationIn this study, unlike similar studies in the literature, participants were grouped based on their oral hygiene status. | Behavioural | Dentabuddy Group with fair oral hygiene, Dentabuddy Group with good oral hygiene, Dentabuddy Group with poor oral hygiene |
| traditional oral hygiene motivationThe group demonstrating the brushing technique on a braces model | Behavioural | Assistant based trainning with fair oral hygiene Group, Assistant based trainning with good oral hygiene Group, Assistant based trainning with poor oral hygiene Group |
Primary outcome
Oral hygiene in patients undergoing fixed orthodontic treatment
Time frame: From August to November 2023
Participants whose oral hygiene scores are monitored through the use of the Dentabuddy application. The Gingival Index (GI) and Plaque Index (PI) are assessed on four surfaces of each tooth (mesial, distal, buccal/labial, and lingual) using a scale from 0 to 3. The total score from all evaluated sites is summed and divided by the total number of teeth to obtain the mean GI and PI values. A reduction in values will indicate a positive outcome of the study.
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 12 Mar 2025.
- Results publication: PubMed 25799001Zotti F, Dalessandri D, Salgarello S, Piancino M, Bonetti S, Visconti L, Paganelli C. Usefulness of an app in improving oral hygiene compliance in adolescent orthodontic patients. Angle Orthod. 2016 Jan;86(1):101-7. doi: 10.2319/010915-19.1. Epub 2015 Mar 23.
- Individual participant dataSharing planned: Undecided
Related trials for Oral Hygiene Education Methods
Active, not recruiting
Motivational Interviewing to Improve Oral Hygiene in Adolescent Orthodontic Patients
Gingivitis, DMFT Index
Recruiting
Evaluation of a Novel Dual-Headed Toothbrush Design for Periodontal Health: Split-Mouth Randomized Blind Clinical Trial
Dental Plaque Accumulation, Oral Hygiene Education Methods
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.
Seda Sağoğlu, Research Assistant principal investigator
Konya Necmettin Erbaka University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Hygiene Education Methods, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
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 4 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 12 Mar 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 Turkey (Türkiye). 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 in patients undergoing fixed orthodontic treatment (time frame: From August to November 2023). 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 NCT06865625, which also lists 1 linked publication.
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 12 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.