NCT07655193

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
25mo left

Started Aug 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

2.1 years

First QC Date

June 5, 2026

Last Update Submit

June 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Study Arms (2)

Patients

Young people with Maxillary Lateral Incisor Agenesis (+/- parent or guardian)

Other: Interview / Focus group

Clinicians

Any clinicians involved in multidisciplinary hypodontia clinics where treatment decision-making occurs.

Other: Interview / Focus group

Interventions

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.

CliniciansPatients

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patient Participants: patients attending the dental department for routine appointments Clinician Participants: clinicians working within the dental department

You may qualify if:

  • 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

You may not qualify if:

  • Craniofacial anomalies including cleft lip and/or palate
  • Unable to communicate in English where no professional translation service is available
  • 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
  • Any clinician not providing care as part of the Hypodontia pathway and working within the multidisciplinary hypodontia clinics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anodontia

Interventions

Interviews as TopicFocus Groups

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 17, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share