SIXES: Should I eXtract Every Six? A Study of the Extraction of Permanent Molar Teeth in Children. (SIXES)
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|ClinicalTrials.gov Identifier: NCT01591265|
Recruitment Status : Terminated (Poor recruitment)
First Posted : May 3, 2012
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Paediatric Dentistry||Procedure: Extraction of upper and lower FPM teeth Procedure: Extraction of lower FPM tooth||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||SIXES: Should I eXtract Every Six? A Randomized Clinical Trial of the Extraction of First Permanent Molar Teeth in Children|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||March 25, 2015|
|Actual Study Completion Date :||March 25, 2015|
Active Comparator: Compensatory Extraction
Patients allocated to this group, both the upper FPM and lower FPM teeth will be extracted.
Procedure: Extraction of upper and lower FPM teeth
Extraction of upper and lower FPM teeth
Active Comparator: No Compensatory Extraction
Patients allocated to this group, only the lower FPM tooth will be extracted.
Procedure: Extraction of lower FPM tooth
Extraction of lower FPM tooth only
- Extent of tipping of the lower second permanent molars [ Time Frame: 5 year ]
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.
- position of the upper FPMs with regard to over-eruption [ Time Frame: 1 year and 5 year ]
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.
- residual spacing between the lower second permanent molar and the lower second premolar*; [ Time Frame: 1 year and 5 year ]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.
- American Board of Orthodontics (ABO) scores [ Time Frame: 1 year and 5 year ]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.
- the type of anaesthetic used during procedures [ Time Frame: at baseline only ]Compare whether there is a difference in the type of anesthetic used by the dentist dependent on the intervention allocated.
- dental or orthodontic treatment carried out during the follow-up period [ Time Frame: 1 year and 5 year ]To compare if there is a difference in the frequency or type of dental or orthodontic treatment between the two groups of children.
- Child and Parent Oral Health Related Quality of Life (OHRQoL) scores [ Time Frame: 1 year and 5 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591265
|Springfield Community Dental Practive|
|Arbroath, Angus, United Kingdom, DD11|
|Dumfries & Galloway Royal Infirmary|
|Dumfries, Dumfries & Galloway, United Kingdom, DG1 4AP|
|Dundee Dental School, University of Dundee|
|Dundee, Tayside, United Kingdom, DD1 9SY|
|Kingscross Hospital Community Dental Service|
|Dundee, Tayside, United Kingdom, DD3 8EA DD3 8EA|
|Broxden Community Dental Practice|
|Perth, Tayside, United Kingdom, PH1 1TJ|
|Principal Investigator:||David R Bearn, MOrth MFDS||University of Dundee|
|Principal Investigator:||Nicola Innes, PhD, MFDS,||University of Dundee|