Improving Decision-Making for Missing Upper Front Teeth

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Decision Aid; Hypodontia; Decision Making ,Shared
• Intervention / Treatment: Other: Interview / Focus group

• Study Type: Observational
• Enrollment (Estimated): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Young people with Maxillary Lateral Incisor Agenesis (+/- parent or guardian)	Other: Interview / Focus group; 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.
Clinicians; Any clinicians involved in multidisciplinary hypodontia clinics where treatment decision-making occurs.	Other: Interview / Focus group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: King's College London

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Tooth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Anodontia; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic; Focus Groups
• Other Study ID Numbers: 359545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No