Condition category
Oral Health
Date applied
12/06/2007
Date assigned
05/07/2007
Last edited
21/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 lesion’s 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 measures

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

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

http://www.sehd.scot.nhs.uk/cso/

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

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21921249

Publication citations

  1. 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.

Additional files

Editorial Notes