HypodontiaNCT07655193
Improving Decision-Making for Missing Upper Front Teeth
An observational study of Hypodontia and Decision Making ,Shared, run by King's College London.
Trial summary
Background: The developmental absence of 1-2 upper front teeth is a common condition, affecting 1 in 50 people worldwide, and affects smile aesthetics and quality-of-life. Treatment is often undertaken in teenagers, but the outcomes have lifelong consequences. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypodontia, Decision Making ,Shared, Decision Aid
- What is being tested?
- Interview / Focus group
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Aug 2028
- Phase
- Observational
- 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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patient Participants: patients attending the dental department for routine appointments Clinician Participants: clinicians working within the dental department
Patient Participant Inclusion Criteria:
- Young people with Maxillary Lateral Incisor Agenesis (MLIA) affecting one or both maxillary lateral incisors
- Young people aged 11-18 years old (attending with an adult with parental responsibility if <16 years old)
- In active orthodontic (space-closure or space-opening) or restorative treatment for MLIA, or completed active dental treatment less than one year ago
- Attended a multidisciplinary Hypodontia Clinic for treatment planning where both space-closure and space-opening options were offered
Patient Participant Exclusion Criteria:
- Craniofacial anomalies including cleft lip and/or palate
- Unable to communicate in English where no professional translation service is available
Clinician Participant Inclusion Criteria:
- Specialists or consultants in orthodontics, restorative dentistry, paediatric dentistry, and oral surgery who provide care as part of the Hypodontia pathway and work within the multidisciplinary hypodontia clinics
Clinician Participant Exclusion Criteria:
- Any clinician not providing care as part of the Hypodontia pathway and working within the multidisciplinary hypodontia clinics
About this study
Official title: Development of a Patient Decision Aid for the Treatment of Maxillary Lateral Incisor Agenesis
Background: The developmental absence of 1-2 upper front teeth is a common condition, affecting 1 in 50 people worldwide, and affects smile aesthetics and quality-of-life. Treatment is often undertaken in teenagers, but the outcomes have lifelong consequences. Treatment options involve either creating space for a false tooth, or closing space and disguising the adjacent tooth as the missing tooth; both options have their own advantages, disadvantages and long-term considerations, and treatment often requires input from multiple dental specialties. Advances in orthodontic techniques mean more patients can be treated with either approach, therefore, the ideal treatment plan becomes more subjective and based upon the patient's preferences.
Aim: To develop a Patient Decision Aid (PDA), a decision-making support tool to help young people (and parents/guardians) with developmentally missing upper front teeth choose the best treatment option for them.
Approach: First, the investigators will gather information from stakeholders involved in the decision-making process to understand their needs. Interviews will be conducted with young people with developmentally missing upper front teeth and their parents/guardians about their experiences, expectations, and preferences regarding treatment decision-making. Information will also be sought from clinicians involved in this process about their experiences of the decision-making process, via focus groups. These will be carried out across two NHS hospitals with special clinics for missing teeth. Then, the information obtained from both patient and clinician stakeholder groups will help the investigators to develop a PDA, following international guidelines. PDA development will occur alongside ongoing input and feedback from a Development Panel (which will include patients and clinician representatives) to optimise content, acceptability, and accessibility. The final approved PDA will then be trialled in a later pilot study.
- Conditions
- Hypodontia, Decision Making ,Shared, Decision Aid
- Being tested
- Interview / Focus group
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview / Focus groupOther
Interviews with patient participants and focus groups with clinician participants will be used to elicit information about experiences with decision-making with regards to treatment options for Maxillary Lateral Incisor Agenesis.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Young people with Maxillary Lateral Incisor Agenesis (+/- parent or guardian) Receives: Other: Interview / Focus group | |
| Clinicians | Any clinicians involved in multidisciplinary hypodontia clinics where treatment decision-making occurs. Receives: Other: Interview / Focus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative experience
Qualitative data from interviews / focus groups on experiences of treatment decision-making for MLIA, which will be thematically analysed using the Framework method.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypodontiaStudies 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
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655193
- Sponsor's protocol ID
- 359545
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 17 Jun 2026
- 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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Patient Decision Aid for the Treatment of Maxillary Lateral Incisor Agenesis
- ClinicalTrials.gov ID
- NCT07655193
- Acronym / sponsor ID
- 359545
- Conditions
- Hypodontia, Decision Making ,Shared, Decision Aid
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 17 Jun 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.
Background: The developmental absence of 1-2 upper front teeth is a common condition, affecting 1 in 50 people worldwide, and affects smile aesthetics and quality-of-life. Treatment is often undertaken in teenagers, but the outcomes have lifelong consequences. Treatment options involve either creating space for a false tooth, or closing space and disguising the adjacent tooth as the missing tooth; both options have their own advantages, disadvantages and long-term considerations, and treatment often requires input from multiple dental specialties. Advances in orthodontic techniques mean more patients can be treated with either approach, therefore, the ideal treatment plan becomes more subjective and based upon the patient's preferences.
Aim: To develop a Patient Decision Aid (PDA), a decision-making support tool to help young people (and parents/guardians) with developmentally missing upper front teeth choose the best treatment option for them.
Approach: First, the investigators will gather information from stakeholders involved in the decision-making process to understand their needs. Interviews will be conducted with young people with developmentally missing upper front teeth and their parents/guardians about their experiences, expectations, and preferences regarding treatment decision-making. Information will also be sought from clinicians involved in this process about their experiences of the decision-making process, via focus groups. These will be carried out across two NHS hospitals with special clinics for missing teeth. Then, the information obtained from both patient and clinician stakeholder groups will help the investigators to develop a PDA, following international guidelines. PDA development will occur alongside ongoing input and feedback from a Development Panel (which will include patients and clinician representatives) to optimise content, acceptability, and accessibility. The final approved PDA will then be trialled in a later pilot study.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Interview / Focus groupYoung people with Maxillary Lateral Incisor Agenesis (+/- parent or guardian) |
| Clinicians | – | Other: Interview / Focus groupAny clinicians involved in multidisciplinary hypodontia clinics where treatment decision-making occurs. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patient Participants: patients attending the dental department for routine appointments Clinician Participants: clinicians working within the dental department
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 |
|---|---|---|
| Interview / Focus groupInterviews with patient participants and focus groups with clinician participants will be used to elicit information about experiences with decision-making with regards to treatment options for Maxillary Lateral Incisor Agenesis. | Other | Clinicians, Patients |
Primary outcome
Qualitative experience
Time frame: Day 1
Qualitative data from interviews / focus groups on experiences of treatment decision-making for MLIA, which will be thematically analysed using the Framework method.
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 17 Jun 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypodontia and Decision Making ,Shared, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Qualitative experience (time frame: Day 1). 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 17 Jun 2026.