NCT04265183

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

January 20, 2020

Last Update Submit

February 10, 2020

Conditions

Hypomineralization of Enamel

Keywords

preformed metal crownsHall technique

Outcome Measures

Primary Outcomes (3)

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

    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).

    1-2 year

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

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

    1-2 year

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

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

    1-2 year

Secondary Outcomes (2)

  • 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 Arms (1)

patients treated with preformed metal crowns

EXPERIMENTAL

All patients included received a preformed metal crown on their HSPM affected teeth.

Other: Placing preformed metal crowns using Hall technique.

Interventions

Placing preformed metal crowns using Hall technique.OTHER

Preformed metal crowns (3M™ ESPE™ STAINLESS STEEL CROWNS) were placed after using separation elastics (Dentalastics® separators, DENTAURUM). The crowns were cemented using is a self-curing, radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement (Ketac™ Cem Plus Luting Cement, 3M™ ESPE™). The technique used to place the crowns was the Hall technique (technique without tooth preparation).

patients treated with preformed metal crowns

Eligibility Criteria

Age24 Months - 144 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related Publications (6)

  • Mayhew D, Mendonca V, Murthy BVS. A review of ASA physical status - historical perspectives and modern developments. Anaesthesia. 2019 Mar;74(3):373-379. doi: 10.1111/anae.14569. Epub 2019 Jan 15.

    PMID: 30648259BACKGROUND

  • Ghanim A, Elfrink M, Weerheijm K, Marino R, Manton D. A practical method for use in epidemiological studies on enamel hypomineralisation. Eur Arch Paediatr Dent. 2015 Jun;16(3):235-46. doi: 10.1007/s40368-015-0178-8. Epub 2015 Apr 28.

    PMID: 25916282BACKGROUND

  • Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.

    PMID: 17518963BACKGROUND

  • Kulkarni P, Agrawal S, Bansal A, Jain A, Tiwari U, Anand A. Assessment of nickel release from various dental appliances used routinely in pediatric dentistry. Indian J Dent. 2016 Apr-Jun;7(2):81-5. doi: 10.4103/0975-962X.184649.

    PMID: 27433051BACKGROUND

  • Tonmukayakul U, Martin R, Clark R, Brownbill J, Manton D, Hall M, Armfield J, Smith M, Shankumar R, Sivasithamparam K, Martin-Kerry J, Calache H. Protocol for the Hall Technique study: A trial to measure clinical effectiveness and cost-effectiveness of stainless steel crowns for dental caries restoration in primary molars in young children. Contemp Clin Trials. 2015 Sep;44:36-41. doi: 10.1016/j.cct.2015.07.005. Epub 2015 Jul 18.

    PMID: 26196586RESULT

  • Wada K, Kanazawa H, Kudo M, Kindaichi J, Miyashin M. Management of developmental enamel defects in the primary dentition. J Oral Sci. 2017;59(3):457-460. doi: 10.2334/josnusd.16-0805.

    PMID: 28904324RESULT

Related Links

MeSH Terms

Conditions

Dental Enamel Hypomineralization

Condition Hierarchy (Ancestors)

Developmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Dominique Declerck, Prof. Dr.

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Declerck, Prof. Dr.

CONTACT

+3216332307dominique.declerck@uzleuven.be

Emily Mampay

CONTACT

emily.mampay@uzleuven.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2020

First Posted

February 11, 2020

Study Start

November 9, 2018

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)