Study Stopped
Poor recruitment
SIXES: Should I eXtract Every Six? A Study of the Extraction of Permanent Molar Teeth in Children.
SIXES
1 other identifier
interventional
7
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2014
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2012
CompletedFirst Posted
Study publicly available on registry
May 3, 2012
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2015
CompletedJune 29, 2018
June 1, 2018
11 months
April 30, 2012
June 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
position of the upper FPMs with regard to over-eruption
1 year and 5 year
residual spacing between the lower second permanent molar and the lower second premolar*;
1 year and 5 year
American Board of Orthodontics (ABO) scores
1 year and 5 year
the type of anaesthetic used during procedures
at baseline only
dental or orthodontic treatment carried out during the follow-up period
1 year and 5 year
- +1 more secondary outcomes
Study Arms (2)
Compensatory Extraction
ACTIVE COMPARATORPatients allocated to this group, both the upper FPM and lower FPM teeth will be extracted.
No Compensatory Extraction
ACTIVE COMPARATORPatients allocated to this group, only the lower FPM tooth will be extracted.
Interventions
Extraction of upper and lower FPM teeth
Eligibility Criteria
You may qualify if:
- Age: 7 -11 years
- Dental History: Able to co-operate with dental treatment
- Regular attender or considered likely to return for follow-up Social History
- Child and carer able to understand study documentation and give consent to participate in study
- Dental condition:
- One or two lower FPMs requiring extraction
- Upper FPMs are sound or restorable/ restored with good long term prognosis (i.e. has or requires a single surface restoration with caries less than half-way into dentine, restoration with a simple restoration)
- Confirmed presence of all second premolars and all second molars
You may not qualify if:
- Medical History: Medical contraindication to dental extractions
- Dental condition: Poor prognosis of premolars or permanent second molar teeth
- All four upper incisors in crossbite
- Poor prognosis of upper FPM
- Confirmed absence of one or more second premolars and second molars
- Declines to have impressions taken
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Professor David Bearnlead
- NHS Taysidecollaborator
Study Sites (5)
Springfield Community Dental Practive
Arbroath, Angus, DD11, United Kingdom
Dumfries & Galloway Royal Infirmary
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
Related Publications (1)
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.
PMID: 23442547DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
David R Bearn, MOrth MFDS
University of Dundee
- PRINCIPAL INVESTIGATOR
Nicola Innes, PhD, MFDS,
University of Dundee
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Cheif Investigator
Study Record Dates
First Submitted
April 30, 2012
First Posted
May 3, 2012
Study Start
May 1, 2014
Primary Completion
March 25, 2015
Study Completion
March 25, 2015
Last Updated
June 29, 2018
Record last verified: 2018-06