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Clinical Trials/NCT04265183
NCT04265183
Unknown
Not Applicable

Preformed Metal Crowns (PMCs) as a Treatment of Children With Hypomineralised Second Primary Molars (HSPM) Using the Hall Technique (HT)

Universitaire Ziekenhuizen KU Leuven1 site in 1 country15 target enrollmentNovember 9, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypomineralization of Enamel
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
15
Locations
1
Primary Endpoint
The clinical success of preformed metal crowns using Hall technique on hypomineralised second primary molars based on clinical acceptable results.
Last Updated
6 years ago

Overview

Brief Summary

Hypomineralised primary second molars are primary molars with a developmental disorder of the enamel. Preformed metal crowns already have good results for the treatment of caries on primary molars. In this study the aim is to investigate the clinical success and overall survival of preformed metal crowns as a treatment for hypomineralised primary molars. The crowns were placed using the Hall technique which is a simplified way of placing these crowns.

Registry
clinicaltrials.gov
Start Date
November 9, 2018
End Date
July 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emily Mampay

Principal Investigator

Universitaire Ziekenhuizen KU Leuven

Eligibility Criteria

Inclusion Criteria

  • age 2-12 years
  • American Society of Anesthesiologists(ASA)-score I: healthy patient
  • hypomineralisation grade: 2-6
  • caries with an International Caries Detection and Assessment System (ICDAS)- score: 0-3
  • limited provoked pain complaint

Exclusion Criteria

  • caries with an ICDAS-score: 4-6
  • pulpitis pain complaints
  • infection (clinical and/or radiographic)
  • \>1/3 root resorption
  • allergies to the used materials

Outcomes

Primary Outcomes

The clinical success of preformed metal crowns using Hall technique on hypomineralised second primary molars based on clinical acceptable results.

Time Frame: 1-2 year

The results are clinical acceptable when there are no clinical signs of infection of the tooth, no caries development or heavy bleeding of the gingiva (after probing).

The overall survival rate of preformed metal crowns using Hall technique on hypomineralised second primary molars is defined as acceptable radiographical outcomes.

Time Frame: 1-2 year

The outcomes are radiographical acceptable when no signs of infection or interproximal bone loss are seen on the radiographs.

The overall survival rate of preformed metal crowns using Hall technique on hypomineralised second primary molars is defined as acceptable clinical outcomes.

Time Frame: 1-2 year

The outcomes are clinically acceptable when there are no signs of infection (abscess) or caries.

Secondary Outcomes

  • The results can be affected by bruxism. Signs of bruxism will not mean failure. We will rate the wear as acceptable or successful. This bruxism will be measured by clinical signs of wear on the crowns.(1-2 year)
  • The oral hygiene of the patient will be measured using the Simplified Oral Hygiene Index. The minimum value is 0: clean. The maximum value is 3: tooth surface covered with >2/3 soft dental plaque. The higher the score, the worse the outcome.(1-2 year)

Study Sites (1)

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