SIXES: Should I eXtract Every Six? A Randomized Clinical Trial of the Extraction of First Permanent Molar Teeth in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 7
- Locations
- 5
- Primary Endpoint
- Extent of tipping of the lower second permanent molars
Study Overview
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Compensatory Extraction
Patients allocated to this group, both the upper FPM and lower FPM teeth will be extracted.
Intervention: Extraction of upper and lower FPM teeth (Procedure)
No Compensatory Extraction
Patients allocated to this group, only the lower FPM tooth will be extracted.
Intervention: Extraction of lower FPM tooth (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Child and Parent Oral Health Related Quality of Life (OHRQoL) scores(1 year and 5 year)
Investigators
Professor David Bearn
Cheif Investigator
University of Dundee