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Poor recruitment
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| Name | Class |
|---|---|
| NHS Tayside | OTHER_GOV |
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This clinical trial investigates relative benefits (clinical effectiveness and quality of life) of two extraction patterns when lower first permanent molars (FPM) are extracted in children The study objectives are to determine whether compensating extraction of upper FPMs following loss of lower FPMs in children is of benefit. The particular benefits being investigated are related to the resulting occlusion, patient experience and oral health related quality of life. The follow up will extend over a period of 5 years or until the patient is 14 years of age - whichever is earlier.
The study has been designed as a randomised controlled clinical trial. The control group will have the normal standard intervention receiving routine patient care with the normal practice of upper and lower extractions, whilst the intervention group will have removal of the lower tooth but no upper extraction. Study recruitment will take place over an 18 month period and will be based in the Dundee Dental Hospital Orthodontic and Paediatric Dentistry Departments. Patients are referred to this department from their General Dental Practitioner.
Consent of the patients will be carried out by the attending dentists who will have received training on the study design and protocol, including RGF and consenting patients for clinical trials.
Data will be collected contemporaneously using the Case Report Forms. Additional data which will be collected for the purposes of the study will include COHQoL questionnaires and measurements from 3D images of models of the teeth.
At subsequent 1 year and five year review visits dental study 3D models will be repeated, and the CRF completed together with the COHQoL questionnaire for that visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compensatory Extraction | Active Comparator | Patients allocated to this group, both the upper FPM and lower FPM teeth will be extracted. |
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| No Compensatory Extraction | Active Comparator | Patients allocated to this group, only the lower FPM tooth will be extracted. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extraction of upper and lower FPM teeth | Procedure | Extraction of upper and lower FPM teeth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extent of tipping of the lower second permanent molars | The primary outcome measure is extent of tipping of the lower second permanent molar, with a favourable outcome being a degree of tipping less than 15°, and unfavourable outcome being greater than 15°. Participants will be allocated into 'favourable' or 'unfavourable' outcome groups when comparing study models, cast from dental impressions taken at baseline with 1 year and 5 year follow up or when the patient reaches 14 years of age, whichever is first. | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| position of the upper FPMs with regard to over-eruption | The secondary outcomes for the study are: 1.position of the upper FPMs with regard to over-eruption;Outcome will be measured on study models of the teeth, cast from impressions taken at baseline and after 1 year and 5 years or when the participant reaches 14 years of age, whichever is first. | 1 year and 5 year |
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Inclusion Criteria:
Dental condition:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| David R Bearn, MOrth MFDS | University of Dundee | Principal Investigator |
| Nicola Innes, PhD, MFDS, | University of Dundee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Springfield Community Dental Practive | Arbroath | Angus | DD11 | United Kingdom | ||
| Dumfries & Galloway Royal Infirmary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23442547 | Derived | Innes N, Borrie F, Bearn D, Evans D, Rauchhaus P, McSwiggan S, Page LF, Hogarth F. Should I eXtract Every Six dental trial (SIXES): study protocol for a randomized controlled trial. Trials. 2013 Feb 27;14:59. doi: 10.1186/1745-6215-14-59. |
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| Extraction of lower FPM tooth | Procedure | Extraction of lower FPM tooth only |
|
| residual spacing between the lower second permanent molar and the lower second premolar*; | Outcome be measured on study models of the teeth, cast from impressions taken at baseline and after 1 year and 5 years or when the participant reaches 14 years of age, whichever is first. | 1 year and 5 year |
| American Board of Orthodontics (ABO) scores | Outcome will be measured on study models of the teeth, cast from impressions taken at baseline and after 1 year and 5 years or when the participant reaches 14 years of age, whichever is first. | 1 year and 5 year |
| the type of anaesthetic used during procedures | Compare whether there is a difference in the type of anesthetic used by the dentist dependent on the intervention allocated. | at baseline only |
| dental or orthodontic treatment carried out during the follow-up period | To compare if there is a difference in the frequency or type of dental or orthodontic treatment between the two groups of children. | 1 year and 5 year |
| Child and Parent Oral Health Related Quality of Life (OHRQoL) scores | Child and Parent Oral Health Related Quality of Life (OHRQoL) scores (child and parent questionnaires)will be assessed at one year and 5 year follow up and compared with baseline. | 1 year and 5 year |
| Dumfries |
| Dumfries & Galloway |
| DG1 4AP |
| United Kingdom |
| Dundee Dental School, University of Dundee | Dundee | Tayside | DD1 9SY | United Kingdom |
| Kingscross Hospital Community Dental Service | Dundee | Tayside | DD3 8EA DD3 8EA | United Kingdom |
| Broxden Community Dental Practice | Perth | Tayside | PH1 1TJ | United Kingdom |