TeledentistryNCT07611227
Teleorthodontics Versus Conventional Follow-up During Early Interceptive Orthodontic Treatment in Children
A study testing Remote Monitoring via Smartphone Application and Conventional Monitoring in people with Teledentistry and Orthodontics, Interceptive, run by Murad Alrashidi at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to learn if teleorthodontic remote monitoring is as effective as traditional in-office care for children undergoing Phase I expansion therapy. It will also evaluate whether this technology can safely reduce the frequency of unscheduled emergency appointments. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Teledentistry, Orthodontics, Interceptive, Palatal Expansion Technique
- What is being tested?
- Remote Monitoring via Smartphone Application and Conventional Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 2 May 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 7 to 11 years
- Scheduled to commence interceptive orthodontic treatment with a maxillary or mandibular Hyrax® expansion appliance
- In the mixed dentition stage
- Parent or legal guardian owns and is able to operate a compatible smartphone (iOS 14 or higher, or Android 10 or higher) capable of running the Dental Monitoring application
- Parent or guardian able and willing to provide written informed consent, and child able to provide assent
Who cannot join
- Craniofacial syndromes or congenital craniofacial anomalies
- Requirement for complex multidisciplinary management
- Lack of reliable internet access, defined as inability to upload photographs at least once per week
- Any prior orthodontic treatment
- Significant systemic medical conditions affecting orthodontic treatment outcomes
- Absence of a consistent legal guardian available to participate in the monitoring protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Teleorthodontics Versus Conventional Follow-up in Pediatric Patients During Phase I Interceptive Orthodontic Treatment. A Randomized Controlled Trial Protocol Comparing Clinical Effectiveness and Parental Satisfaction.
The goal of this clinical trial is to learn if teleorthodontic remote monitoring is as effective as traditional in-office care for children undergoing Phase I expansion therapy. It will also evaluate whether this technology can safely reduce the frequency of unscheduled emergency appointments.
Main Questions
Read more
The study aims to answer the following:
- Is remote monitoring non-inferior to conventional care in improving dental alignment, as measured by the Peer Assessment Rating (PAR) Index?
- Does the use of weekly smartphone-based photo check-ins significantly lower the number of unscheduled emergency visits?
- How does remote monitoring impact appliance compliance, parental satisfaction, and the child's level of distress during treatment?
Comparison
Researchers will compare a teleorthodontics group-which uses weekly smartphone photography and clinic visits every 8 weeks-to a conventional group receiving standard in-person follow-ups every 4 weeks.
Participant Activities
Participants will:
- Commence Phase I treatment using a maxillary or mandibular expansion appliance.
- If assigned to the teleorthodontics group, capture a standardized set of five intraoral photographs weekly via a dedicated smartphone application.
- Attend scheduled in-office checkups every 4 or 8 weeks, depending on their assigned group.
- Maintain a daily diary to record appliance activations and report on their treatment experience.
Read the detailed description
This trial will evaluate the clinical and logistical impact of integrating artificial intelligence (AI)-driven remote monitoring into pediatric interceptive orthodontics. While teleorthodontics has shown success in adult populations, this study will focus on children aged 7-11 years, where craniofacial growth is rapid and treatment depends heavily on parental involvement.
Trial Design:
This prospective, two-arm, parallel-group, randomized non-inferiority trial will be conducted at a university-based orthodontic clinic. The study will follow a hierarchical testing structure: first establishing the non-inferiority of treatment effectiveness (PAR Index change), followed by testing the superiority of remote monitoring in reducing unscheduled emergency visits.
Intervention Protocols:
Participants will be randomized in a 1:1 ratio to one of two monitoring modalities: Teleorthodontics Group (TG):Participants will receive a maxillary or mandibular Hyrax® expansion appliance. Parents will be trained to use the DentalMonitoring® smartphone application to capture five standardized intraoral photographs every week. The platform will use AI-driven image analysis to detect changes in tooth position, appliance status, and oral hygiene. A calibrated orthodontist will review all submissions within 48 hours and communicate with parents via in-app messaging. Scheduled in-office visits will occur at 8-week intervals. Conventional Group (CG):Participants will receive the same expansion therapy but will follow a traditional 4-week in-office visit schedule. No remote monitoring technology or smartphone-based photography will be utilized in this group.
Technical Monitoring and Safety In the teleorthodontics group, the AI system will flag clinical concerns such as loose bands or activation errors. The trial will investigate if these automated alerts allow for the remote resolution of minor issues, thereby preventing unnecessary travel for the families. Safety will be monitored by recording all adverse events, including mucosal irritation or appliance deformation, in both groups.
Statistical Methodology The trial is powered to detect non-inferiority based on a pre-specified margin of -3 points on the weighted PAR Index. Primary Analysis: An Intention-to-Treat (ITT) approach will be used, employing ANCOVA adjusted for baseline PAR scores and age strata. Emergency Visits: Superiority regarding unscheduled visits will be analyzed using negative binomial regression, accounting for treatment duration and travel distance. Sensitivity Analyses: To ensure robustness, researchers will perform per-protocol (PP) analyses and multiple imputation by chained equations (MICE) to handle any missing data. Subgroup Analysis: Exploratory analyses will examine if treatment effects differ based on the severity of the initial malocclusion or the geographic distance the family must travel to the clinic.
- Being tested
- Remote Monitoring via Smartphone Application, Conventional Monitoring
- Keywords
- Phase I Orthodontic Treatment, Interceptive Orthodontics, Hyrax Appliance, Teleorthodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Monitoring via Smartphone ApplicationOther
Use of artificial intelligence (AI)-driven intraoral photography employing Dental Monitoring mobile application to monitor Phase I expansion therapy remotely.
Conventional MonitoringOther
Participants follow a standard care protocol involving physical examinations during in-person clinic visits scheduled every 4 weeks. No digital monitoring or smartphone-based photography is utilized
| Study group | Role | What they receive |
|---|---|---|
| Teleorthodontics Group (TG) | Experimental | Participants receive Phase I expansion therapy with a Hyrax® expander. Monitoring includes weekly remote intraoral photography via the Dental Monitoring platform and scheduled in-office visits every 8 weeks. Receives: Other: Remote Monitoring via Smartphone Application |
| Conventional Group (CG) | Active comparator | Participants receive the same Phase I expansion therapy with a Hyrax® expander. Monitoring follows a standard protocol with in-office visits scheduled every 4 weeks. Receives: Other: Conventional Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weighted Peer Assessment Rating (PAR) Index
This measure assesses the clinical effectiveness of the orthodontic treatment by calculating the difference between the baseline PAR score and the score at the completion of Phase I therapy. A single blinded and calibrated examiner performs the measurements using study models or digital scans. The trial is designed as a non-inferiority test, with a pre-specified margin of -3 points.
Measured: 12 months
Number of Unscheduled Emergency In-Person Visits.
This measure tracks healthcare utilization and service efficiency by counting the total number of emergency or unscheduled clinic visits required for each participant. These visits are triggered by patient-reported concerns or, in the remote monitoring group, by clinical issues detected during AI-assisted photo review. This outcome is tested for superiority conditional on establishing the non-inferiority of the PAR Index change.
Measured: 12 months
Secondary outcomes (3)
Parental Satisfaction
Parental satisfaction with the assigned monitoring modality will be assessed at the treatment midpoint and at treatment completion using the Modified Telehealth Satisfaction Questionnaire (MTSQ). The MTSQ comprises 16 items distributed across four domains: convenience (4 items), communication (4 items), clinical confidence (4 items), and overall experience (4 items). Each item is rated on a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). Total scores are calculated as the sum of all items and range from a minimum of 16 to a maximum of 80, with higher scores indicating greater parental satisfaction with the monitoring experience.
Measured: 12 months
Child-Reported Experience
The child's level of pain or distress associated with the monitoring process will be assessed using the Wong-Baker FACES Pain Rating Scale, a self-report instrument validated for children aged 3 years and older. The scale presents six cartoon faces ranging from a smiling face to a crying face, each corresponding to a numeric value: 0 (no hurt), 2 (hurts little bit), 4 (hurts little more), 6 (hurts even more), 8 (hurts whole lot), and 10 (hurts worst). Scores therefore range from a minimum of 0 to a maximum of 10, with higher scores indicating greater pain or distress.
Measured: 12 months
Adverse Events and Safety
he frequency and severity of any adverse events, such as mucosal irritation, loose bands or brackets, and appliance deformation, will be monitored throughout the trial
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start2 May 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
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 TeledentistryStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murad Alrashidi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murad Alrashidi, Qassim University
- Investigators
- MURAD A ALRASHDI, Principal investigator, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611227
- Sponsor's protocol ID
- 26-20-2
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share individual participant data that underlie the results reported in the final publication, after de-identification. This may include the weighted PAR Index scores, number of unscheduled visits, and survey responses (MTSQ and Wong-Baker FACES scales).The study protocol and statistical analysis plan (SAP) will be made available upon request. Data will be shared with researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee. Proposals should be directed to the primary investigator. To gain access, data requestors will need to sign a data access agreement.
Publications
Kazimierczak N, Kazimierczak W, Serafin Z, Nowicki P, Nozewski J, Janiszewska-Olszowska J. AI in Orthodontics: Revolutionizing Diagnostics and Treatment Planning-A Comprehensive Review. J Clin Med. 2024 Jan 7;13(2):344. doi: 10.3390/jcm13020344.
PubMed 38256478Kengne Talla P, Allison P, Bussieres A, Rodrigues A, Bergeron F, Giraudeau N, Emami E. Teledentistry for Improving Access To, and Quality of Oral Health Care: Overview of Systematic Reviews and Meta-Analyses. J Med Internet Res. 2025 Jul 30;27:e65211. doi: 10.2196/65211.
PubMed 40737673DeGuzman L, Bahiraei D, Vig KW, Vig PS, Weyant RJ, O'Brien K. The validation of the Peer Assessment Rating index for malocclusion severity and treatment difficulty. Am J Orthod Dentofacial Orthop. 1995 Feb;107(2):172-6. doi: 10.1016/s0889-5406(95)70133-8.
PubMed 7847276
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teleorthodontics Versus Conventional Follow-up in Pediatric Patients During Phase I Interceptive Orthodontic Treatment. A Randomized Controlled Trial Protocol Comparing Clinical Effectiveness and Parental Satisfaction.
- ClinicalTrials.gov ID
- NCT07611227
- Acronym / sponsor ID
- 26-20-2
- Keywords
- Phase I Orthodontic Treatment, Interceptive Orthodontics, Hyrax Appliance, Teleorthodontics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Murad AlrashidiUniversity, hospital or other
- Study start
- 2 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 May 2026 (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 goal of this clinical trial is to learn if teleorthodontic remote monitoring is as effective as traditional in-office care for children undergoing Phase I expansion therapy. It will also evaluate whether this technology can safely reduce the frequency of unscheduled emergency appointments.
Main Questions
The study aims to answer the following:
- Is remote monitoring non-inferior to conventional care in improving dental alignment, as measured by the Peer Assessment Rating (PAR) Index?
- Does the use of weekly smartphone-based photo check-ins significantly lower the number of unscheduled emergency visits?
- How does remote monitoring impact appliance compliance, parental satisfaction, and the child's level of distress during treatment?
Comparison
Researchers will compare a teleorthodontics group-which uses weekly smartphone photography and clinic visits every 8 weeks-to a conventional group receiving standard in-person follow-ups every 4 weeks.
Participant Activities
Participants will:
- Commence Phase I treatment using a maxillary or mandibular expansion appliance.
- If assigned to the teleorthodontics group, capture a standardized set of five intraoral photographs weekly via a dedicated smartphone application.
- Attend scheduled in-office checkups every 4 or 8 weeks, depending on their assigned group.
- Maintain a daily diary to record appliance activations and report on their treatment experience.
Detailed description
This trial will evaluate the clinical and logistical impact of integrating artificial intelligence (AI)-driven remote monitoring into pediatric interceptive orthodontics. While teleorthodontics has shown success in adult populations, this study will focus on children aged 7-11 years, where craniofacial growth is rapid and treatment depends heavily on parental involvement.
Trial Design:
This prospective, two-arm, parallel-group, randomized non-inferiority trial will be conducted at a university-based orthodontic clinic. The study will follow a hierarchical testing structure: first establishing the non-inferiority of treatment effectiveness (PAR Index change), followed by testing the superiority of remote monitoring in reducing unscheduled emergency visits.
Intervention Protocols:
Participants will be randomized in a 1:1 ratio to one of two monitoring modalities: Teleorthodontics Group (TG):Participants will receive a maxillary or mandibular Hyrax® expansion appliance. Parents will be trained to use the DentalMonitoring® smartphone application to capture five standardized intraoral photographs every week. The platform will use AI-driven image analysis to detect changes in tooth position, appliance status, and oral hygiene. A calibrated orthodontist will review all submissions within 48 hours and communicate with parents via in-app messaging. Scheduled in-office visits will occur at 8-week intervals. Conventional Group (CG):Participants will receive the same expansion therapy but will follow a traditional 4-week in-office visit schedule. No remote monitoring technology or smartphone-based photography will be utilized in this group.
Technical Monitoring and Safety In the teleorthodontics group, the AI system will flag clinical concerns such as loose bands or activation errors. The trial will investigate if these automated alerts allow for the remote resolution of minor issues, thereby preventing unnecessary travel for the families. Safety will be monitored by recording all adverse events, including mucosal irritation or appliance deformation, in both groups.
Statistical Methodology The trial is powered to detect non-inferiority based on a pre-specified margin of -3 points on the weighted PAR Index. Primary Analysis: An Intention-to-Treat (ITT) approach will be used, employing ANCOVA adjusted for baseline PAR scores and age strata. Emergency Visits: Superiority regarding unscheduled visits will be analyzed using negative binomial regression, accounting for treatment duration and travel distance. Sensitivity Analyses: To ensure robustness, researchers will perform per-protocol (PP) analyses and multiple imputation by chained equations (MICE) to handle any missing data. Subgroup Analysis: Exploratory analyses will examine if treatment effects differ based on the severity of the initial malocclusion or the geographic distance the family must travel to the clinic.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teleorthodontics Group (TG) | Experimental | Other: Remote Monitoring via Smartphone ApplicationParticipants receive Phase I expansion therapy with a Hyrax® expander. Monitoring includes weekly remote intraoral photography via the Dental Monitoring platform and scheduled in-office visits every 8 weeks. |
| Conventional Group (CG) | Active comparator | Other: Conventional MonitoringParticipants receive the same Phase I expansion therapy with a Hyrax® expander. Monitoring follows a standard protocol with in-office visits scheduled every 4 weeks. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 7 to 11 years
- Scheduled to commence interceptive orthodontic treatment with a maxillary or mandibular Hyrax® expansion appliance
- In the mixed dentition stage
- Parent or legal guardian owns and is able to operate a compatible smartphone (iOS 14 or higher, or Android 10 or higher) capable of running the Dental Monitoring application
- Parent or guardian able and willing to provide written informed consent, and child able to provide assent
Key exclusion criteria (6 listed)
- Craniofacial syndromes or congenital craniofacial anomalies
- Requirement for complex multidisciplinary management
- Lack of reliable internet access, defined as inability to upload photographs at least once per week
- Any prior orthodontic treatment
- Significant systemic medical conditions affecting orthodontic treatment outcomes
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 |
|---|---|---|
| Remote Monitoring via Smartphone ApplicationUse of artificial intelligence (AI)-driven intraoral photography employing Dental Monitoring mobile application to monitor Phase I expansion therapy remotely. | Other | Teleorthodontics Group (TG) |
| Conventional MonitoringParticipants follow a standard care protocol involving physical examinations during in-person clinic visits scheduled every 4 weeks. No digital monitoring or smartphone-based photography is utilized | Other | Conventional Group (CG) |
Primary outcome
Change in Weighted Peer Assessment Rating (PAR) Index
Time frame: 12 months
This measure assesses the clinical effectiveness of the orthodontic treatment by calculating the difference between the baseline PAR score and the score at the completion of Phase I therapy. A single blinded and calibrated examiner performs the measurements using study models or digital scans. The trial is designed as a non-inferiority test, with a pre-specified margin of -3 points.
Number of Unscheduled Emergency In-Person Visits.
Time frame: 12 months
This measure tracks healthcare utilization and service efficiency by counting the total number of emergency or unscheduled clinic visits required for each participant. These visits are triggered by patient-reported concerns or, in the remote monitoring group, by clinical issues detected during AI-assisted photo review. This outcome is tested for superiority conditional on establishing the non-inferiority of the PAR Index change.
3 secondary outcomes
Parental Satisfaction
Time frame: 12 months
Child-Reported Experience
Time frame: 12 months
Adverse Events and Safety
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 38256478Kazimierczak N, Kazimierczak W, Serafin Z, Nowicki P, Nozewski J, Janiszewska-Olszowska J. AI in Orthodontics: Revolutionizing Diagnostics and Treatment Planning-A Comprehensive Review. J Clin Med. 2024 Jan 7;13(2):344. doi: 10.3390/jcm13020344.
- Background: PubMed 40737673Kengne Talla P, Allison P, Bussieres A, Rodrigues A, Bergeron F, Giraudeau N, Emami E. Teledentistry for Improving Access To, and Quality of Oral Health Care: Overview of Systematic Reviews and Meta-Analyses. J Med Internet Res. 2025 Jul 30;27:e65211. doi: 10.2196/65211.
- Background: PubMed 7847276DeGuzman L, Bahiraei D, Vig KW, Vig PS, Weyant RJ, O'Brien K. The validation of the Peer Assessment Rating index for malocclusion severity and treatment difficulty. Am J Orthod Dentofacial Orthop. 1995 Feb;107(2):172-6. doi: 10.1016/s0889-5406(95)70133-8.
- Individual participant dataSharing planned: Yes. The investigators will share individual participant data that underlie the results reported in the final publication, after de-identification. This may include the weighted PAR Index scores, number of unscheduled visits, and survey responses (MTSQ and Wong-Baker FACES scales).The study protocol and statistical analysis plan (SAP) will be made available upon request. Data will be shared with researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee. Proposals should be directed to the primary investigator. To gain access, data requestors will need to sign a data access agreement.
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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.
MURAD A ALRASHDI principal investigator
Qassim 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 Remote Monitoring via Smartphone Application and Conventional Monitoring in people with Teledentistry and Orthodontics, Interceptive, run by Murad Alrashidi 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 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Weighted Peer Assessment Rating (PAR) Index (time frame: 12 months). 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 NCT07611227, 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 13 Oct 2026.