Analysis of Treatment Outcomes in Patients Affected by Molar-Incisor Hypomineralization (MIH)

NCT06228989 | Active Not Recruiting

• 1 other identifier: 276481
• Study Type: interventional
• Target: 282
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim is to long-term evaluate extraction or restoration therapy, of first permanent molars with extensive treatment needs as a result of severe MIH in a national multicenter study concerning dental fear and anxiety, oral health-related quality of life, jaw development, and health economics.

Conditions

Hypomineralization of Enamel; Dental Fear; Quality of Life

Outcome Measures

Primary Outcomes (3)

• Dental fear and anxiety

  Questionnaire: Children's Fear Survey Schedule - Dental Subscale (CFSS-DS). Range 15-75, lower score indicated lower dental fear and anxiety

  At baseline - age 6-9 years (T0), At 1st follow-up - age 11 years (T1), At 2nd follow-up - age 15 years (T2))

• Oral helth-related quality of life

  Questionnaire: Short form of Child Perceptions Questionnaire for 11-14-year-old children (CPQ11-14). Range 0-64, lower score indicated better oral helth-related quality of life

  At baseline - age 6-9 years (T0), At 1st follow-up - age 11 years (T1), At 2nd follow-up - age 15 years (T2))

• Health economics

  Journal extract: nummber of dental visits and the length of dental visits. More dental chairtime indicates a higher health economic impact.

  At baseline - age 6-9 years (T0), At 1st follow-up - age 11 years (T1), At 2nd follow-up - age 15 years (T2))

Study Arms (4)

Extraction therapy

EXPERIMENTAL

Patients exclusive treated with extraction therapy of any first permanent molars due to severe MIH. Affected first permanent molars were dignosed with MIH degree 4-6.

Procedure: Extraction therapy

Restorative therapy

EXPERIMENTAL

Patients exclusive treated with restorative therapy of any first permanent molars due to severe MIH. Affected first permanent molars were dignosed with MIH degree 4-5.

Procedure: Restorative therapy

Extraction therapy and Restorative therapy

EXPERIMENTAL

Patients undergoing combined treatment of both extraction therapy and restorative therapy of their first permanent molars due to MIH. Affected first permanent molars treated with extraction therapy were dignosed with MIH degree 6. Affected first permanent molars treated with restorative therapy were dignosed with MIH degree 4-5.

Procedure: Restorative therapy; Procedure: Extraction therapy

Control patients

NO INTERVENTION

Patients devoid of any enamel developmental defects, attending the Public Dental Service in Region Västra Götaland, constituted a basis for the control patients. These controls were matched in terms of gender, age, and socio-economic factors, with each study patient paired with seven potential control patients.

Interventions

Restorative therapy PROCEDURE

Restorative treatment of first permanent molars affected with severe MIH

Extraction therapy and Restorative therapy; Restorative therapy

Extraction therapy PROCEDURE

Extraction treatment of first permanent molars affected with severe MIH

Extraction therapy; Extraction therapy and Restorative therapy

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-9 years
• Diagnosed with at least one first permanent molar with MIH defree 4-6

You may not qualify if:

• Dental agenesis
• General disorders, including chronic diseases and functional limitations

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator
• Region Östergötland: collaborator
• Malmö University: collaborator

MeSH Terms

Conditions

Dental Enamel Hypomineralization

Condition Hierarchy (Ancestors)

Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Agneta Robertson

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicentre prospective randomized controlled trial

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 29, 2024
• Study Start: January 1, 2016
• Primary Completion: January 31, 2020
• Study Completion (Estimated): September 4, 2028
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After 2028
• Access Criteria: The data will be de-identified