Dental Caries
Conditions
Keywords
Class II carious primary molar, Non-Restorative Caries Treatment, Hall Technique, Conventional restorations, Children
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).
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.
Interventions
PROCEDUREHall 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
PROCEDURENon-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.
PROCEDUREConventional 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
Sponsors
University of Dundee
Lithuanian University of Health Sciences
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure Rate of the Three Treatment Arms Judged Clinically | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction | 2 years | Number of children experiencing irreversible pulpitis, dental abscess, or extraction judged clinically after 2 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Oral Health Status | 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 | 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. |
| Number of Participants Reporting Pain Experience During Treatment | 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. |
Countries
Germany, Lithuania, United Kingdom
Participant flow
Recruitment details
Patients were recruited between 2011 and 2012 from the Preventive and Paediatric Dentistry Department of Greifswald University, Germany.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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:
* 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 | 52 |
| 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. | 52 |
| Conventional Restoration Conventional Restoration: Technique:
* Local anesthesia should be used when needed
* Complete caries removal and cavity preparation
* Use a matrix band and a wedge to tightly hold the band against the tooth
* Place the material (Composite) under cotton wool roll isolation and continuous aspiration.
* Check contacts and occlusion, and polish the restoration. | 65 |
| Total | 169 |
Baseline characteristics
| Characteristic | Hall Technique | Non-Restorative Caries Treatment | Conventional Restoration | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 52 Participants | 52 Participants | 65 Participants | 169 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.25 years STANDARD_DEVIATION 1.56 | 5.62 years STANDARD_DEVIATION 1.48 | 5.77 years STANDARD_DEVIATION 1.32 | 5.56 years STANDARD_DEVIATION 1.45 |
| Sex: Female, Male Female | 19 Participants | 25 Participants | 29 Participants | 73 Participants |
| Sex: Female, Male Male | 33 Participants | 27 Participants | 36 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 52 | 0 / 65 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 | 0 / 65 |
Outcome results
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
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hall Technique | Failure Rate of the Three Treatment Arms Judged Clinically | Minor Failure | 2 Teeth |
| Hall Technique | Failure Rate of the Three Treatment Arms Judged Clinically | Successful | 37 Teeth |
| Hall Technique | Failure Rate of the Three Treatment Arms Judged Clinically | Major Failure | 1 Teeth |
| Non-Restorative Caries Treatment | Failure Rate of the Three Treatment Arms Judged Clinically | Minor Failure | 9 Teeth |
| Non-Restorative Caries Treatment | Failure Rate of the Three Treatment Arms Judged Clinically | Successful | 31 Teeth |
| Non-Restorative Caries Treatment | Failure Rate of the Three Treatment Arms Judged Clinically | Major Failure | 3 Teeth |
| Conventional Restoration | Failure Rate of the Three Treatment Arms Judged Clinically | Successful | 39 Teeth |
| Conventional Restoration | Failure Rate of the Three Treatment Arms Judged Clinically | Major Failure | 5 Teeth |
| Conventional Restoration | Failure Rate of the Three Treatment Arms Judged Clinically | Minor Failure | 14 Teeth |
Comparison: The null hypothesis was no difference at 2 yrs among any of the 3 arms for the primary outcome of success or minor failure.p-value: 0.02Kruskal-Wallis
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
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hall Technique | Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction | 3 Participants |
| Non-Restorative Caries Treatment | Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction | 1 Participants |
| Conventional Restoration | Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction | 5 Participants |
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.
Time frame: Baseline assessment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hall Technique | Number of Participants Reporting Pain Experience During Treatment | Very low/low pain during treatment | 42 Participants |
| Hall Technique | Number of Participants Reporting Pain Experience During Treatment | > Moderate pain during treatment | 10 Participants |
| Non-Restorative Caries Treatment | Number of Participants Reporting Pain Experience During Treatment | Very low/low pain during treatment | 46 Participants |
| Non-Restorative Caries Treatment | Number of Participants Reporting Pain Experience During Treatment | > Moderate pain during treatment | 6 Participants |
| Conventional Restoration | Number of Participants Reporting Pain Experience During Treatment | Very low/low pain during treatment | 47 Participants |
| Conventional Restoration | Number of Participants Reporting Pain Experience During Treatment | > Moderate pain during treatment | 18 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.
Time frame: Baseline assessment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hall Technique | Number of Participants With Negative and Positive Behavior During Treatment | Positive behaviour during treatment | 45 Participants |
| Hall Technique | Number of Participants With Negative and Positive Behavior During Treatment | Negative behaviour during treatment | 7 Participants |
| Non-Restorative Caries Treatment | Number of Participants With Negative and Positive Behavior During Treatment | Negative behaviour during treatment | 11 Participants |
| Non-Restorative Caries Treatment | Number of Participants With Negative and Positive Behavior During Treatment | Positive behaviour during treatment | 41 Participants |
| Conventional Restoration | Number of Participants With Negative and Positive Behavior During Treatment | Negative behaviour during treatment | 24 Participants |
| Conventional Restoration | Number of Participants With Negative and Positive Behavior During Treatment | Positive behaviour during treatment | 41 Participants |
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
Time frame: 1 and 2 years