PMCs as a Treatment of Children With HSPM Using the HT

Not Applicable

• Conditions: Hypomineralization of Enamel
• Interventions: Other: Placing preformed metal crowns using Hall technique.

• Registration Number: NCT04265183
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-09
• Study First Submitted: 2020-01-20
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-10
• Last Update Submitted: 2020-02-10
• Study First Posted: 2020-02-11
• Last Update Posted: 2020-02-11
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients treated with preformed metal crowns	Placing preformed metal crowns using Hall technique.	All patients included received a preformed metal crown on their HSPM affected teeth.

Primary Outcome Measures

Name	Time	Method
The clinical success of preformed metal crowns using Hall technique on hypomineralised second primary molars based on clinical acceptable results.	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.	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.	1-2 year	The outcomes are clinically acceptable when there are no signs of infection (abscess) or caries.

Secondary Outcome Measures

Name	Time	Method
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	When the wear of the crown is limited to minimal loss of metal, it is rated successful. When the wear is going through the full thickness of the crown until the underlying tooth structure, it is rated as acceptable.
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	Oral hygiene of the patients scored as debris \>1/3 of the crown surface is scored as bad oral hygiene. Bad oral hygiene implies a higher prevalence of (heavy) bleeding of the gingiva after probing. Which has a significant influence on the clinical success of the crowns.

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium