PMCs as a Treatment of Children With HSPM Using the HT

Hypomineralization of Enamel Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04265183
• Other study ID #: B322201837979
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: February 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Dominique Declerck, Prof. Dr.
• Phone: +3216332307
• Email: dominique.declerck[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 144 Months

Eligibility

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

Related Conditions & MeSH terms

• Hypomineralization of Enamel

Intervention

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).

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

Ghanim A, Elfrink M, Weerheijm K, Mariño 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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 st — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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

External Links

•   Restorative management of dental enamel defects in the primary dentition