Dental CariesNCT01797458
European Study on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth
A study testing Hall Technique, Non-Restorative Caries Treatment and Conventional Restoration in people with Dental Caries, run by University Medicine Greifswald at 3 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Hall Technique, Non-Restorative Caries Treatment and Conventional Restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 3 sitesin 3 countries
- Study dates
- May 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
Ernst-Moritz-Arndt-Universität Greifswald. Dental Faculty, Preventive and Paediatric Dentistry Department
Greifswald, Mecklenburg-Vorpommern, 17487
Lithuania1 site
Lithuanian University of Health Sciences, Dental Faculty, Clinic of Dental and Oral Pathology
Kaunas
United Kingdom1 site
University of Dundee, Dentistry & Nursing , College of Medicine, Unit of Dental and Oral Health School of Dentistry
Dundee
About this study
Official title: Randomised Control Trial 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).
Read the 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.
- Conditions
- Dental Caries
- Being tested
- Hall Technique, Non-Restorative Caries Treatment, Conventional Restoration
- Keywords
- Class II carious primary molar, Non-Restorative Caries Treatment, Hall Technique, Conventional restorations, Children
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hall TechniqueProcedure or surgery
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 TreatmentProcedure or surgery
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 RestorationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Conventional Restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction
Number of children experiencing irreversible pulpitis, dental abscess, or extraction judged clinically after 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startMay 2011
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dundee, Lithuanian University of Health Sciences
- Responsible party
- Principal investigator, Christian Splieth, University Medicine Greifswald
- Investigators
- Christian H Splieth, Prof. Dr., Study chair, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797458
- Sponsor's protocol ID
- BB 39/11
- Other IDs
- The 3,2,1 Study
- Status last verified
- Aug 2022
- First submitted
- 20 Feb 2013
- Last updated
- 7 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25216660Santamaria 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.
PubMed 24602167Santamaria 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.
PubMed 29258064
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Control Trial on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth
- ClinicalTrials.gov ID
- NCT01797458
- Acronym / sponsor ID
- BB 39/11
- Conditions
- Dental Caries
- Keywords
- Class II carious primary molar, Non-Restorative Caries Treatment, Hall Technique, Conventional restorations, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- University of Dundee, Lithuanian University of Health Sciences
- Study start
- May 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Posted 10 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hall Technique | Experimental | Procedure: Hall TechniqueThis technique uses preformed Stainless Steel Crowns (SSCs) to restore carious primary molars. Local anaesthesia, caries removal or tooth preparation are not required. |
| Non-Restorative Caries Treatment | Experimental | Procedure: Non-Restorative Caries TreatmentThis 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. |
| Conventional Restoration | Active comparator | Procedure: Conventional RestorationThis 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. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hall TechniqueTechnique: * 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 | Procedure or surgery | Hall Technique |
| Non-Restorative Caries TreatmentTechnique: * 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. | Procedure or surgery | Non-Restorative Caries Treatment |
| Conventional RestorationTechnique: * 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 | Procedure or surgery | Conventional Restoration |
Primary outcome
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
1 secondary outcome
Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25216660Santamaria 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.
- Results publication: PubMed 24602167Santamaria 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.
- Derived from this study: PubMed 29258064Santamaria 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian H Splieth, Prof. Dr. study chair
University Medicine Greifswald
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hall Technique, Non-Restorative Caries Treatment and Conventional Restoration in people with Dental Caries, run by University Medicine Greifswald at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Lithuania, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure Rate of the Three Treatment Arms Judged Clinically (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01797458, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.