European Study on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Medicine Greifswald
Sponsor:
Collaborators:
University of Dundee
Lithuanian University of Health Sciences
Information provided by (Responsible Party):
Christian Splieth, University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT01797458
First received: February 20, 2013
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

The purpose of this randomized clinical trial is to compare the clinical effectiveness of three treatments involving different caries management strategies (conventional restorations, Hall technique, and a non-restorative treatment of dental caries) to the management of class II carious primary molar in children 3-8 year-old from three different countries (Scotland, Lithuania, and Germany).


Condition Intervention
Dental Caries
Procedure: Hall Technique
Procedure: Opening-up Cavities
Procedure: Conventional Restorations

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Control Trial on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth

Resource links provided by NLM:


Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • Failure rate of the three treatment arms judged clinically [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Failure rate of the three treatment arms judged clinically after 1 and 2 years such as clear caries progression, secondary caries, loss of restoration, reversible pulpitis treated without requiring pulpotomy


Secondary Outcome Measures:
  • Number of children experiencing irreversible pulpitis, dental abscess, or extraction [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
    Number of children experiencing irreversible pulpitis, dental abscess, or extraction judged clinically after 1 and 2 years


Other Outcome Measures:
  • Oral health status [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
    Child`s oral health status as assessed by the gingival status and bacterial plaque index judged clinically after 1 and 2 years

  • Children behavior [ Time Frame: Baseline assessment ] [ Designated as safety issue: No ]
    Child's behavior as assessed by the Frankl Behavior Rating Scale

  • Acceptability of three caries management techniques for children, parents, and dentists [ Time Frame: Baseline assessment ] [ Designated as safety issue: No ]
    Acceptability of the different management techniques for children, parents, and dentists

  • Children perception of pain intensity [ Time Frame: Baseline assessment ] [ Designated as safety issue: No ]
    Child's perception of pain intensity during treatment assessed with the Visual Analogue Scale of Faces


Estimated Enrollment: 464
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hall Technique
This technique uses preformed Stainless Steel Crowns (SSCs) to restore carious primary molars. This technique does not require local anesthesia, caries removal or any tooth preparation.
Procedure: Hall Technique

Technique:

  • Removal of dental plaque and rest of aliments from the cavity
  • Selection of the SSC
  • If the contact points are very tight, orthodontic separator elastics could be placed through the mesial and distal contacts and the SSC has to be fitted at a subsequent appointment
  • Dry the crown and fill with glass-ionomer luting cement
  • Place the crown over the tooth
  • Removal of cement excesses from the crown margins
  • The child should be asked to keep biting on the crown until the cement has set
Experimental: Opening-up Cavities
This is a less operative approach, whose aim is to facilitate plaque control in carious lesions, thus making cavities accessible for plaque removal. According to the new understanding of caries nature, it is clear that carious lesions can be arrested even in the case of dentinal involvement, provided that the main causal factor -bacterial plaque- is removed.
Procedure: Opening-up Cavities

Technique:

  • Use high-speed bur to remove the undermined enamel and make the cavity accessible for plaque removal. Do not remove the contact area
  • Clean, dry the cavity and apply Duraphat® varnish fluoride (50/mg/ml)
  • Show the cavity to patient/parents and give them tooth-brushing instructions
  • Tell to parents that good plaque control is the key for this treatment
  • The recall interval for these patients is every 3 months.
Active Comparator: Conventional Restorations
Conventional restorations (dental fillings) with complete caries removal have been used as the standard treatment for carious primary teeth. Exist different materials to restore class II carious primary molars. Resin based materials and amalgam have been considered as appropriate materials in terms of longevity for class II restorations in primary teeth.
Procedure: Conventional Restorations

Technique:

  • Local anesthesia should be used when needed
  • Complete caries removal should be performed and cavity preparation should be done according to the material you have selected
  • Use a matrix band and a wedge to tightly hold the band against the tooth
  • Place the material
  • Check contacts and occlusion, and polish the restoration (only for resin based materials)

Detailed Description:

At present, many materials and techniques are used to treat carious primary teeth. All of these have their proponents who claim they provide the best performance in terms of longevity, aesthetics, bio-compatibility, etc (Qvist, 2010; Yengopal et al., 2009). However, despite the great variety of techniques and materials, there is no definite evidence for the most effective approach when dental caries in primary molars is concerned, as yet. On the other hand, there is conclusive evidence that shows that glass-ionomer cement is an inappropriate material for class II restorations in primary teeth, due to its significant shorter longevity compared with other restorative materials like compomer and amalgam.

Recently, there is re-surging interest in "old" techniques: such as opening-up cavities used in Denmark and Netherlands (Peretz & Gluck, 2006; Gruythuysen et al., 2010) or stainless steel crowns with the advent of the Hall technique in Scotland (Innes et al., 2007). However, there is lack of comparative evidence from high quality clinical trials leading to uncertainty in the effectiveness of these techniques. In addition, these techniques are rarely compared with standard fillings.

  Eligibility

Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children aged 3-8 years (Germany: children who attend the Präventive Zahnmedizin und Kinderzahnheilkunde department at Ernst-Moritz-Arndt-Universität Greifswald; Scotland: children who attend the paediatric dentistry department, School of Dentistry at University of Dundee; Lithuania: children who attend the paediatric dentistry department, Dental Faculty, Lithuanian University of Health Sciences)
  • At least one primary molar tooth with caries into dentine involving two dental surfaces (diagnosed according to International Caries Detection and Assessment System - ICDAS, codes 3 to 5)
  • Willing to be examined

Exclusion Criteria:

  • Clinical or radiographic signs of pulpar or peri-radicular pathology
  • Patients with a systemic disease requiring special considerations during their dental treatment.
  • Parents/children who refuse to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797458

Locations
Germany
Ernst-Moritz-Arndt-Universität Greifswald. Dental Faculty, Preventive and Paediatric Dentistry Department Recruiting
Greifswald, Mecklenburg-Vorpommern, Germany, 17487
Contact: Christian H Splieth, Prof. Dr.    +49 3834 867101    splieth@uni-greifswald.de   
Contact: Ruth M Santamaria    +49 3834 867136    ruth.santamaria@uni-greifswald.de   
Principal Investigator: Christian H Splieth, Prof. Dr.         
Sub-Investigator: Ruth M Santamaria         
Lithuania
Lithuanian University of Health Sciences, Dental Faculty, Clinic of Dental and Oral Pathology Recruiting
Kaunas, Lithuania
Contact: Vita Machiulskiene, Prof. Dr.       vita@med.kmu.lt   
Contact: Julija Narbutaite       julinarb@takas.lt   
Principal Investigator: Vita Machiulskiene, Pr. Dr.         
Sub-Investigator: Julija Narbutaite         
United Kingdom
University of Dundee, Dentistry & Nursing , College of Medicine, Unit of Dental and Oral Health School of Dentistry Not yet recruiting
Dundee, United Kingdom
Contact: Nicola P Innes, Dr.    + 44 1382 425760    n.p.innes@dundee.ac.uk   
Principal Investigator: Nicola P Innes, Dr.         
Sponsors and Collaborators
University Medicine Greifswald
University of Dundee
Lithuanian University of Health Sciences
Investigators
Study Chair: Christian H Splieth, Prof. Dr. Ernst-Moritz-Arndt-Universität Greifswald
  More Information

No publications provided

Responsible Party: Christian Splieth, Prof. Dr., University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT01797458     History of Changes
Other Study ID Numbers: BB 39/11, The 3,2,1 Study
Study First Received: February 20, 2013
Last Updated: February 21, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University Medicine Greifswald:
class II carious primary molar
Opening-up cavities
Hall Technique
Conventional restorations

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 28, 2014