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PMCs as a Treatment of Children With HSPM Using the HT

U

Universitaire Ziekenhuizen KU Leuven

Status

Unknown

Conditions

Hypomineralization of Enamel

Treatments

Other: Placing preformed metal crowns using Hall technique.

Study type

Interventional

Funder types

Other

Identifiers

NCT04265183
B322201837979

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

24 to 144 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

patients treated with preformed metal crowns
Experimental group
Description:
All patients included received a preformed metal crown on their HSPM affected teeth.
Treatment:
Other: Placing preformed metal crowns using Hall technique.

Trial contacts and locations

1

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Central trial contact

Dominique Declerck, Prof. Dr.; Emily Mampay

Data sourced from clinicaltrials.gov

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