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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01797458
First Posted: February 22, 2013
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Dundee
Lithuanian University of Health Sciences
Information provided by (Responsible Party):
Christian Splieth, University Medicine Greifswald
  Purpose
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).

Condition Intervention
Dental Caries Procedure: Hall Technique Procedure: Non-Restorative Caries Treatment Procedure: Conventional Restoration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Control Trial on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth

Resource links provided by NLM:


Further study details as provided by Christian Splieth, University Medicine Greifswald:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Enrollment: 169
Study Start Date: May 2011
Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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

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.
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Germany
Ernst-Moritz-Arndt-Universität Greifswald. Dental Faculty, Preventive and Paediatric Dentistry Department
Greifswald, Mecklenburg-Vorpommern, Germany, 17487
Lithuania
Lithuanian University of Health Sciences, Dental Faculty, Clinic of Dental and Oral Pathology
Kaunas, Lithuania
United Kingdom
University of Dundee, Dentistry & Nursing , College of Medicine, Unit of Dental and Oral Health School of Dentistry
Dundee, United Kingdom
Sponsors and Collaborators
University Medicine Greifswald
University of Dundee
Lithuanian University of Health Sciences
Investigators
Study Chair: Christian H Splieth, Prof. Dr. University Medicine Greifswald
  More Information

Publications:
Responsible Party: Christian Splieth, Prof. Dr., University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT01797458     History of Changes
Other Study ID Numbers: BB 39/11
The 3,2,1 Study ( Other Identifier: Ernst-Moritz-Universität Greifswald )
First Submitted: February 20, 2013
First Posted: February 22, 2013
Results First Submitted: May 16, 2017
Results First Posted: October 10, 2017
Last Update Posted: November 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Christian Splieth, University Medicine Greifswald:
Class II carious primary molar
Non-Restorative Caries Treatment
Hall Technique
Conventional restorations
Children

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases