Contact information
Type
Scientific
Primary contact
Mrs Nicola Innes
ORCID ID
Contact details
Level 9
Dental Hospital and School
University of Dundee
Park Place
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 635992
n.p.innes@dundee.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
It has long been known that the carious process can be arrested. There has been growing awareness that it may not be necessary to remove as much carious dental tissue as was previously thought. By simply changing the environment within which the caries is progressing, and making it unfavourable for the micro-organisms involved, the number and diversity of micro-organisms can be dramatically reduced. This means that the carious disease process may be slowed down, perhaps halted, and possibly even reversed. The Hall technique makes use of a simplified, potentially more acceptable method of placing Preformed Metal Crowns (PMCs). It is used to seal the carious lesion into the tooth, making the environment unfavourable by limiting the lesions access to nutrients. This should slow, or even arrest the progress of the carious lesion through the tooth. In addition, by avoiding the use of Local Anaesthesia (LA) and caries removal, it is possible that the Hall technique might be more acceptable than standard restorative techniques to children, their parents and General Dental Practitioners (GDPs). The randomised controlled clinical trial reported in this thesis was designed to investigate these hypotheses.
The overall aim of the research project was to determine whether the Hall technique offered benefits over current practice to restore carious primary molar teeth in general dental practice in Tayside. Specifically, the potential benefits of interest were:
1. Acceptability of the procedure
2. Long-term pulpal health
3. Longevity of the restoration, and
4. Costs of the procedures together with their follow-up maintenance
This led to the following null hypotheses being tested through the clinical trial:
1. After a minimum of 23 months, there is no difference in the incidence of signs and symptoms of pulpal disease between teeth restored with control restorations and those with PMCs fitted using the Hall technique
2. After a minimum of 23 months, there is no difference in longevity of restorations between control restorations and PMCs fitted using the Hall technique
3. Children, their carers and GDPs have no preference between the Hall technique and control restorations placed by their GDPs, and
4. After a minimum of 23 months, there is no difference in the cost of provision and maintenance of the control restorations and Hall PMCs to the service provider
Information on the pilot trial at http://www.dundee.ac.uk/tuith/Articles/rt03.htm
Ethics approval
Received from the Tayside Committee on Medical Research Ethics (ref: 108/00).
Study design
Randomised controlled trial, split-mouth design.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Dental decay
Intervention
A preformed metal (stainless steel) crown will be placed on one of the pairs of carious primary molar teeth of the child. The other molar tooth will be given a standard treatment.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The following outcomes will be assessed at least 23 months after the placement of the crown:
1. Absence of signs/symptoms of pulpal pathology
2. Resoration failure requiring intervention
Secondary outcome measures
1. Acceptability of the intervention technique
2. Cost effectiveness
Overall trial start date
01/07/2001
Overall trial end date
01/07/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children aged 4 to 9 years of age with pairs of carious primary molar teeth, matched for arch, tooth type and extent of caries.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
120
Participant exclusion criteria
Medical contra-indications, i.e., children at risk of infective endocarditis.
Recruitment start date
01/07/2001
Recruitment end date
01/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Level 9
Dundee
DD1 4HN
United Kingdom
Sponsor information
Organisation
Chief Scientist Office (UK)
Sponsor details
Scottish Executive Health Department
St Andrew's House
Regent Road
Edinburgh
EH1 3DG
United Kingdom
+44 (0)131 244 2246
karen.ford@scotland.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Chief Scientists Office (UK) - Research Training Fellowship Award, Scottish Executive
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
3M ESPE (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21921249
Publication citations
-
Results
Innes NP, Evans DJ, Stirrups DR, Sealing caries in primary molars: randomized control trial, 5-year results., J. Dent. Res., 2011, 90, 12, 1405-1410, doi: 10.1177/0022034511422064.