Clinical trial NCT01797458: European Study on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth
Official title: Randomised Control Trial on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Class II carious primary molar
Non-Restorative Caries Treatment
Hall Technique
Conventional restorations
Children
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: University of Dundee
name: Lithuanian University of Health Sciences
First posted: 2013-02-22
Enrollment: 169
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Failure Rate of the Three Treatment Arms Judged Clinically
timeFrame: 2 years
Secondary outcomes:
measure: Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction
timeFrame: 2 years
Other outcomes:
measure: Oral Health Status
timeFrame: 1 and 2 years
measure: Number of Participants With Negative and Positive Behavior During Treatment
timeFrame: Baseline assessment
measure: Number of Participants Reporting Pain Experience During Treatment
timeFrame: Baseline assessment
Locations:
city: Greifswald
country: Germany
facility: Ernst-Moritz-Arndt-Universität Greifswald. Dental Faculty, Preventive and Paediatric Dentistry Department
state: Mecklenburg-Vorpommern
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences, Dental Faculty, Clinic of Dental and Oral Pathology
city: Dundee
country: United Kingdom
facility: University of Dundee, Dentistry & Nursing , College of Medicine, Unit of Dental and Oral Health School of Dentistry
Study officials:
affiliation: University Medicine Greifswald
name: Christian H Splieth, Prof. Dr.
role: STUDY_CHAIR
References:
citation: Santamaria RM, Innes NP, Machiulskiene V, Evans DJ, Splieth CH. Caries management strategies for primary molars: 1-yr randomized control trial results. J Dent Res. 2014 Nov;93(11):1062-9. doi: 10.1177/0022034514550717. Epub 2014 Sep 12.
citation: Santamaria RM, Innes NP, Machiulskiene V, Evans DJ, Alkilzy M, Splieth CH. Acceptability of different caries management methods for primary molars in a RCT. Int J Paediatr Dent. 2015 Jan;25(1):9-17. doi: 10.1111/ipd.12097. Epub 2014 Mar 7.
citation: Santamaria RM, Innes NPT, Machiulskiene V, Schmoeckel J, Alkilzy M, Splieth CH. Alternative Caries Management Options for Primary Molars: 2.5-Year Outcomes of a Randomised Clinical Trial. Caries Res. 2017;51(6):605-614. doi: 10.1159/000477855. Epub 2017 Dec 20.