European Study on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth
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|ClinicalTrials.gov Identifier: NCT01797458|
Recruitment Status : Completed
First Posted : February 22, 2013
Results First Posted : October 10, 2017
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Procedure: Hall Technique Procedure: Non-Restorative Caries Treatment Procedure: Conventional Restoration||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||169 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Control Trial on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2014|
Experimental: 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.
Procedure: Hall Technique
Experimental: 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.
Procedure: Non-Restorative Caries Treatment
Active Comparator: 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.
Procedure: Conventional Restoration
- 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
- Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction [ Time Frame: 2 years ]Number of children experiencing irreversible pulpitis, dental abscess, or extraction judged clinically after 2 years
- Oral Health Status [ Time Frame: 1 and 2 years ]Child`s oral health status as assessed by the gingival status and bacterial plaque index judged clinically after 1 and 2 years
- Number of Participants With Negative and Positive Behavior During Treatment [ Time Frame: Baseline assessment ]Behaviour of children during treatment was assessed using the Frankl Behavior Rating Scale. It is a four-point scale, which ranges from definitely negative behaviour, when the child refuses the treatment to definitely positive behaviour, when the participant is completely cooperative.
- Number of Participants Reporting Pain Experience During Treatment [ Time Frame: Baseline assessment ]Child's perception of pain intensity during treatment was assessed using the Visual Analogue Scale of Faces. It is a five-point scale, which includes five faces of children representing from very light to very intense pain. Participants were asked to select the face that represents how he/she felt during the procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797458
|Ernst-Moritz-Arndt-Universität Greifswald. Dental Faculty, Preventive and Paediatric Dentistry Department|
|Greifswald, Mecklenburg-Vorpommern, Germany, 17487|
|Lithuanian University of Health Sciences, Dental Faculty, Clinic of Dental and Oral Pathology|
|University of Dundee, Dentistry & Nursing , College of Medicine, Unit of Dental and Oral Health School of Dentistry|
|Dundee, United Kingdom|
|Study Chair:||Christian H Splieth, Prof. Dr.||University Medicine Greifswald|