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

NCT01797458 | Completed Results

• 2 other identifiers: BB 39/11The 3,2,1 Study
• Study Type: interventional
• Target: 169
• Locations: 3 countries
• Sites: 3

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).

Conditions

Dental Caries

Keywords

Class II carious primary molar; Non-Restorative Caries Treatment; Hall Technique; Conventional restorations; Children

Outcome Measures

Primary Outcomes (1)

• Failure Rate of the Three Treatment Arms Judged Clinically

  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

  2 years

Secondary Outcomes (1)

• Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction

  2 years

Other Outcomes (3)

• Oral Health Status

  1 and 2 years

• Number of Participants With Negative and Positive Behavior During Treatment

  Baseline assessment

• Number of Participants Reporting Pain Experience During Treatment

  Baseline assessment

Study Arms (3)

Hall Technique

EXPERIMENTAL

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

Non-Restorative Caries Treatment

EXPERIMENTAL

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

Conventional Restoration

ACTIVE COMPARATOR

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

Interventions

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

Hall Technique

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.

Non-Restorative Caries Treatment

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

Conventional Restoration

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medicine Greifswald: lead
• University of Dundee: collaborator
• Lithuanian University of Health Sciences: collaborator

Study Sites (3)

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

Greifswald, Mecklenburg-Vorpommern, 17487, Germany

Location

Lithuanian University of Health Sciences, Dental Faculty, Clinic of Dental and Oral Pathology

Kaunas, Lithuania

Location

University of Dundee, Dentistry & Nursing , College of Medicine, Unit of Dental and Oral Health School of Dentistry

Dundee, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 25216660 RESULT

• 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.

  PMID: 24602167 RESULT

• 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.

  PMID: 29258064 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Prof. Dr. Christian Splieth
• Organization: Preventive and Paediatric Dentistry Department of Greifswald University, Germany

splieth@uni-greifswald.de

+ 49 3834 867101

Study Officials

• Christian H Splieth, Prof. Dr.

  University Medicine Greifswald

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 22, 2013
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: September 7, 2022
• Results First Posted: October 10, 2017

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1); GB (1); DE (1)