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

Not Applicable

Completed

Interventions: Procedure: Hall Technique
Procedure: Non-Restorative Caries Treatment
Procedure: Conventional Restoration

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Hall Technique	Hall Technique	This technique uses preformed Stainless Steel Crowns (SSCs) to restore carious primary molars. Local anaesthesia, caries removal or tooth preparation are not required.
Non-Restorative Caries Treatment	Non-Restorative Caries Treatment	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.
Conventional Restoration	Conventional Restoration	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.

Primary Outcome Measures

Name	Time	Method
Failure Rate of the Three Treatment Arms Judged Clinically	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 Outcome Measures

Name	Time	Method
Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction	2 years	Number of children experiencing irreversible pulpitis, dental abscess, or extraction judged clinically after 2 years

Locations (3): Lithuanian University of Health Sciences, Dental Faculty, Clinic of Dental and Oral Pathology
🇱🇹
Kaunas, Lithuania
Ernst-Moritz-Arndt-Universität Greifswald. Dental Faculty, Preventive and Paediatric Dentistry Department
🇩🇪
Greifswald, Mecklenburg-Vorpommern, Germany
University of Dundee, Dentistry & Nursing , College of Medicine, Unit of Dental and Oral Health School of Dentistry
🇬🇧
Dundee, United Kingdom