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| ID | Type | Description | Link |
|---|---|---|---|
| The 3,2,1 Study | Other Identifier | Ernst-Moritz-Universität Greifswald |
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| Name | Class |
|---|---|
| University of Dundee | OTHER |
| Lithuanian University of Health Sciences | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hall Technique | Procedure | Technique:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Health Status | Child's oral health status as assessed by the gingival status and bacterial plaque index judged clinically after 1 and 2 years | 1 and 2 years |
| Number of Participants With Negative and Positive Behavior During Treatment |
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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian H Splieth, Prof. Dr. | University Medicine Greifswald | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ernst-Moritz-Arndt-Universität Greifswald. Dental Faculty, Preventive and Paediatric Dentistry Department | Greifswald | Mecklenburg-Vorpommern | 17487 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25216660 | Result | 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. | |
| 24602167 | 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. |
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After initial screening from daily patient lists, 181 children were assessed for eligibility from the Preventive and Paediatric Dentistry Department of Greifswald University, Germany. 12 children were initially excluded due to reported systemic diseases, refused to participate, etc.
Patients were recruited between 2011 and 2012 from the Preventive and Paediatric Dentistry Department of Greifswald University, Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Technique:
|
| FG001 | Non-Restorative Caries Treatment | Carious lesions are opened removing the overhanging enamel and making the cavity accessible for biofilm removal. No carious dentine was removed from the pulpal wall and no local anaesthesia was placed. Fluoride varnish (Duraphat ®) was applied to the cavity. Parents/children were trained to clean the cavity by brushing using a buccolingual technique. Recall intervals were every 3 months. |
| FG002 | Conventional Restoration | Technique:
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Hall Technique: Technique:
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | Teeth | 2 years |
|
2 years, 6 months
No adverse events were observed/reported during the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hall Technique | No observed/reported |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Christian Splieth | Preventive and Paediatric Dentistry Department of Greifswald University, Germany | + 49 3834 867101 | splieth@uni-greifswald.de |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Non-Restorative Caries Treatment | Procedure | Technique:
|
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| Conventional Restoration | Procedure | Technique:
|
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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.
| Baseline assessment |
| Number of Participants Reporting Pain Experience During Treatment | 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. | Baseline assessment |
| Lithuanian University of Health Sciences, Dental Faculty, Clinic of Dental and Oral Pathology | Kaunas | Lithuania |
| University of Dundee, Dentistry & Nursing , College of Medicine, Unit of Dental and Oral Health School of Dentistry | Dundee | United Kingdom |
| 29258064 | Derived | 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. |
| BG001 | 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 was removed from the pulpal wall and no local anaesthesia was placed. Fluoride varnish (Duraphat, GABA, Lörrach, Germany) was applied to the cavity. Parents/children were trained to clean the cavity by brushing using a buccolingual technique. Recall interval for these participants was every 3 months. |
| BG002 | Conventional Restoration | Conventional Restoration: Technique:
|
| BG003 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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, GABA, Lörrach, Germany) will be applied to the cavity. Parents/children will be trained to clean the cavity by brushing using a buccolingual technique. Non-Restorative Caries Treatment: Technique:
|
| OG002 | Conventional Restoration | Conventional restorations (dental fillings) with complete caries removal will be performed. Local anaesthesia will be placed when needed. All cavities will be restored with Compomer (Dyract, Dentsply, Konstanz, Germany) under cotton wool roll isolation and continuous aspiration. Technique:
|
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Other Pre-specified | Oral Health Status | Child's oral health status as assessed by the gingival status and bacterial plaque index judged clinically after 1 and 2 years | Not Posted | 1 and 2 years | Participants |
| Other Pre-specified | Number of Participants With Negative and Positive Behavior During Treatment | 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. | Posted | Count of Participants | Participants | Baseline assessment |
|
|
|
| Other Pre-specified | Number of Participants Reporting Pain Experience During Treatment | 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. | Posted | Count of Participants | Participants | Baseline assessment |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Non-Restorative Caries Treatment | No observed/reported | 0 | 52 | 0 | 52 |
| EG002 | Conventional Restoration | No observed/reported | 0 | 65 | 0 | 65 |
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