PMCs as a Treatment of Children With HSPM Using the HT

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypomineralization of Enamel
• Intervention / Treatment: Other: Placing preformed metal crowns using Hall technique.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominique Declerck, Prof. Dr.; Phone Number: +3216332307; Email: dominique.declerck@uzleuven.be
• Study Contact Backup: Name: Emily Mampay; Email: emily.mampay@uzleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven
      • Contact: Dominique Declerck, Prof. Dr.; Phone Number: +3216332307; Email: dominique.declerck@uzleuven.be
      • Contact: Emily Mampay; Email: emily.mampay@uzleuven.be
      • Sub-Investigator: Emily Mampay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: patients treated with preformed metal crowns; All patients included received a preformed metal crown on their HSPM affected teeth.

Other: Placing preformed metal crowns using Hall technique.; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	1-2 year

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Dominique Declerck, Prof. Dr., UZ Leuven

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Restorative management of dental enamel defects in the primary dentition

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): July 31, 2020

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: preformed metal crowns; Hall technique
• Other Study ID Numbers: B322201837979

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No