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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomised Control Trial on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth

Conditions
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Dental Caries

Intervention / Treatment
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* Procedure: Hall Technique
* Procedure: Non-Restorative Caries Treatment
* Procedure: Conventional Restoration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hall Technique<br>This technique uses preformed Stainless Steel Crowns (SSCs) to restore carious primary molars. Local anaesthesia, caries removal or tooth preparation are not required. | Procedure: Hall Technique<br>* 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<br>|
| Experimental: Non-Restorative Caries Treatment<br>This is a less operative approach, here carious lesions are opened removing the overhanging enamel and making the cavity accessible for biofilm removal. No carious dentine will be removed from the pulpal wall and no local anaesthesia will be placed. Fluoride varnish (Duraphat ®) will be applied to the cavity. Parents/children will be trained to clean the cavity by brushing using a buccolingual technique. | Procedure: Non-Restorative Caries Treatment<br>* Technique: A high-speed bur should be used 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.<br>|
| Active Comparator: Conventional Restoration<br>This technique corresponds to the conventional way of treating cavitated carious lesions involving complete caries removal, use of local anaesthesia (when needed), and a compomer (Dyract ®) restoration. Cotton wool roll isolation and continuous aspiration will be used. | Procedure: Conventional Restoration<br>* Technique: Local anesthesia should be used when needed Perform complete caries removal and cavity preparation Use a matrix band and a wedge to tightly hold the band against the tooth Place the material (Compomer) Check contacts and occlusion, and polish the restoration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure Rate of the Three Treatment Arms Judged Clinically | 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 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction | Number of children experiencing irreversible pulpitis, dental abscess, or extraction judged clinically after 2 years | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Class II carious primary molar, Non-Restorative Caries Treatment, Hall Technique, Conventional restorations, Children