NCT01797458

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
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
PROCEDURE	Non-Restorative Caries Treatment	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.
PROCEDURE	Conventional Restoration	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

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-12-01
• Completion: 2014-12-01
• First posted: 2013-02-22
• Last updated: 2022-09-07
• Results posted: 2017-10-10

Locations

3 sites across 3 countries: Germany, Lithuania, United Kingdom