A randomised controlled trial in primary care of a novel method of using preformed metal crowns to manage decay in primary molar teeth: the Hall technique
| ISRCTN | ISRCTN47267892 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47267892 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/06/2007
- Registration date
- 05/07/2007
- Last edited
- 21/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Nicola Innes
Scientific
Scientific
Level 9
Dental Hospital and School
University of Dundee
Park Place
Dundee
DD1 4HN
United Kingdom
| Phone | +44 (0)1382 635992 |
|---|---|
| n.p.innes@dundee.ac.uk |
Study information
| Study design | Randomised controlled trial, split-mouth design. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Received from the Tayside Committee on Medical Research Ethics (ref: 108/00). |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2001 |
| Completion date | 01/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 9 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key 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. |
| Key exclusion criteria | Medical contra-indications, i.e., children at risk of infective endocarditis. |
| Date of first enrolment | 01/07/2001 |
| Date of final enrolment | 01/07/2011 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Level 9
Dundee
DD1 4HN
United Kingdom
DD1 4HN
United Kingdom
Sponsor information
Chief Scientist Office (UK)
Government
Government
Scottish Executive Health Department
St Andrew's House
Regent Road
Edinburgh
EH1 3DG
United Kingdom
| Phone | +44 (0)131 244 2246 |
|---|---|
| karen.ford@scotland.gsi.gov.uk | |
| Website | http://www.sehd.scot.nhs.uk/cso/ |
"ROR" |
https://ror.org/01bw7zm61 |
Funders
Funder type
Government
Chief Scientists Office (UK) - Research Training Fellowship Award, Scottish Executive
No information available
3M ESPE (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2011 | Yes | No |
