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Clinical Trials/NCT06228989
NCT06228989
Active, not recruiting
Not Applicable

Restoration or Extraction as Dental Therapy in First Permanent Molars With Severe Hypomineralized Enamel (MIH) - a National Randomized Prospective Multicenter Study

Göteborg University0 sites282 target enrollmentJanuary 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypomineralization of Enamel
Sponsor
Göteborg University
Enrollment
282
Primary Endpoint
Dental fear and anxiety
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Detailed Description

First permanent molars often show areas of porous and hypomineralized enamel. This manifests itself clinically as whitish-yellow to brownish well-defined spots and, in severe disorders, disintegration of enamel. One to all molars are affected and at the same time, the permanent incisors may show opacities. The condition is called Molar-Incisor Hypomineralization (MIH) and occurs in 14% of children globally. Affected teeth create problems for the individual. The teeth are often painful, e.g. when brushing teeth, cold food/drink, or even when inhaling cold air. Dental treatment can be painful because it is difficult to get adequate anesthesia, probably due to subclinical pulp inflammation caused by the porosity of the enamel. Molars with severely demineralized enamel need dental care shortly after they have erupted due to decay and subsequent caries. 9-year-old children with severe MIH had their PFM treated almost ten times as often as a healthy control group. In case of widespread decay and hypersensitivity, extraction may be a treatment option. Two retrospective studies dealing with the extraction of first permanent molars due to MIH have been published: one study found that 87% showed acceptable gap closure and another study showed that 3 of 27 extraction cases had an objective need and only one case had a subjective need for orthodontic gap closure after the extraction. A review article discusses the scientific basis for treating severe first permanent molar due to severe MIH, and the author claims that both the profession and the public today believe in a more conservative restorative treatment. However, he states that there is a need for well-controlled long-term studies. 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
September 4, 2028
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Göteborg University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Dental fear and anxiety

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

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

Oral helth-related quality of life

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

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

Health economics

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

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

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