Randomised Control Trial on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Dental Caries
- Sponsor
- University Medicine Greifswald
- Enrollment
- 169
- Locations
- 3
- Primary Endpoint
- Failure Rate of the Three Treatment Arms Judged Clinically
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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 Non-Restorative Caries Treatment) to the management of class II carious primary molars in children (3-8 year-old).
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 more biological (less-invasive) techniques: such as the Non-Restorative Caries Treatment (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.
Investigators
Christian Splieth
Prof. Dr.
University Medicine Greifswald
Eligibility Criteria
Inclusion Criteria
- •Children aged 3-8 years who attend the Preventive and Paediatric Department of Greifswald University, Germany.
- •(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 the International Caries Detection and Assessment System \[ICDAS\], codes 3 to 5)
- •Willing to be examined
Exclusion Criteria
- •Clinical or radiographic signs of pulpal 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
Outcomes
Primary Outcomes
Failure Rate of the Three Treatment Arms Judged Clinically
Time Frame: 2 years
Failure rate of the three treatment arms judged clinically after 2 years such as clear caries progression, secondary caries, loss of restoration, reversible pulpitis treated without requiring pulpotomy
Secondary Outcomes
- Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction(2 years)