Trial Outcomes & Findings for European Study on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth (NCT NCT01797458)
NCT ID: NCT01797458
Last Updated: 2022-09-07
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
169 participants
Primary outcome timeframe
2 years
Results posted on
2022-09-07
Participant Flow
Patients were recruited between 2011 and 2012 from the Preventive and Paediatric Dentistry Department of Greifswald University, Germany.
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.
Participant milestones
| Measure |
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:
* 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
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.
|
Conventional Restoration
Technique:
* Local anaesthesia was 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 (Compomer)
* Check contacts and occlusion, and polish the restoration
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
65
|
|
Overall Study
COMPLETED
|
40
|
43
|
58
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
European Study on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth
Baseline characteristics by cohort
| Measure |
Hall Technique
n=52 Participants
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
|
Non-Restorative Caries Treatment
n=52 Participants
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.
|
Conventional Restoration
n=65 Participants
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.
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
52 Participants
n=39 Participants
|
52 Participants
n=41 Participants
|
65 Participants
n=35 Participants
|
169 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
5.25 years
STANDARD_DEVIATION 1.56 • n=39 Participants
|
5.62 years
STANDARD_DEVIATION 1.48 • n=41 Participants
|
5.77 years
STANDARD_DEVIATION 1.32 • n=35 Participants
|
5.56 years
STANDARD_DEVIATION 1.45 • n=31 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
73 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=39 Participants
|
27 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
96 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 2 yearsFailure 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
Outcome measures
| Measure |
Hall Technique
n=40 Participants
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
|
Non-Restorative Caries Treatment
n=43 Participants
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:
* Use high-speed bur 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
n=58 Participants
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:
* 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 (Composer)
* Check contacts and occlusion, and polish the restoration
|
|---|---|---|---|
|
Failure Rate of the Three Treatment Arms Judged Clinically
Successful
|
37 Teeth
|
31 Teeth
|
39 Teeth
|
|
Failure Rate of the Three Treatment Arms Judged Clinically
Minor Failure
|
2 Teeth
|
9 Teeth
|
14 Teeth
|
|
Failure Rate of the Three Treatment Arms Judged Clinically
Major Failure
|
1 Teeth
|
3 Teeth
|
5 Teeth
|
SECONDARY outcome
Timeframe: 2 yearsNumber of children experiencing irreversible pulpitis, dental abscess, or extraction judged clinically after 2 years
Outcome measures
| Measure |
Hall Technique
n=43 Participants
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
|
Non-Restorative Caries Treatment
n=40 Participants
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:
* Use high-speed bur 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
n=58 Participants
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:
* 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 (Composer)
* Check contacts and occlusion, and polish the restoration
|
|---|---|---|---|
|
Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction
|
3 Participants
|
1 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 and 2 yearsChild's oral health status as assessed by the gingival status and bacterial plaque index judged clinically after 1 and 2 years
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline assessmentBehaviour 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.
Outcome measures
| Measure |
Hall Technique
n=52 Participants
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
|
Non-Restorative Caries Treatment
n=52 Participants
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:
* Use high-speed bur 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
n=65 Participants
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:
* 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 (Composer)
* Check contacts and occlusion, and polish the restoration
|
|---|---|---|---|
|
Number of Participants With Negative and Positive Behavior During Treatment
Negative behaviour during treatment
|
7 Participants
|
11 Participants
|
24 Participants
|
|
Number of Participants With Negative and Positive Behavior During Treatment
Positive behaviour during treatment
|
45 Participants
|
41 Participants
|
41 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline assessmentChild'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.
Outcome measures
| Measure |
Hall Technique
n=52 Participants
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
|
Non-Restorative Caries Treatment
n=52 Participants
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:
* Use high-speed bur 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
n=65 Participants
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:
* 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 (Composer)
* Check contacts and occlusion, and polish the restoration
|
|---|---|---|---|
|
Number of Participants Reporting Pain Experience During Treatment
> Moderate pain during treatment
|
10 Participants
|
6 Participants
|
18 Participants
|
|
Number of Participants Reporting Pain Experience During Treatment
Very low/low pain during treatment
|
42 Participants
|
46 Participants
|
47 Participants
|
Adverse Events
Hall Technique
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Restorative Caries Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Restoration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hall Technique
n=52 participants at risk
No observed/reported
|
Non-Restorative Caries Treatment
n=52 participants at risk
No observed/reported
|
Conventional Restoration
n=65 participants at risk
No observed/reported
|
|---|---|---|---|
|
Infections and infestations
|
0.00%
0/52 • 2 years, 6 months
No adverse events were observed/reported during the study period.
|
0.00%
0/52 • 2 years, 6 months
No adverse events were observed/reported during the study period.
|
0.00%
0/65 • 2 years, 6 months
No adverse events were observed/reported during the study period.
|
Other adverse events
Adverse event data not reported
Additional Information
Prof. Dr. Christian Splieth
Preventive and Paediatric Dentistry Department of Greifswald University, Germany
Phone: + 49 3834 867101
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place