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Completed

NCT Number: NCT01797458

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

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).

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Key information

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ernst-Moritz-Arndt-Universität Greifswald. Dental Faculty, Preventive and Paediatric Dentistry Department, Greifswald, Mecklenburg-Vorpommern, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hall technique

Procedure

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

Non-Restorative Caries Treatment

Procedure

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.

Conventional Restoration

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. 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 outcomes

  1. 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

  2. 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 (definitely negative, negative, positive, definitely positive.

    This scale ranges from definitely negative behaviour, when the child refuses the treatment (worse outcome) to definitely positive behaviour (best outcome), when the participant is completely cooperative.

    In this scale a score is not reported, thus categories are not converted into numerical data.

  3. 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 (1 to 5), which includes five faces of children representing from very light to very intense pain (very low, low, moderate, intense, very intense), with higher scores representing worst outcomes (pain) and low scores best outcomes (no pain).

    Participants were asked to select the face that represents how he/she felt during the procedure.

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • Lithuanian University of Health Sciences
  • University of Dundee

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Feb 22, 2013
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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