SIXES: Should I eXtract Every Six? A Study of the Extraction of Permanent Molar Teeth in Children.

Paediatric Dentistry Clinical Trial

— SIXES  

Official title:

SIXES: Should I eXtract Every Six? A Randomized Clinical Trial of the Extraction of First Permanent Molar Teeth in Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01591265
• Other study ID #: 2011DE02
• Status: Terminated
• Phase: N/A
• Start date: May 2014
• Est. completion date: March 25, 2015

Study information

• Verified date: June 2018
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 25, 2015
• Est. primary completion date: March 25, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Paediatric Dentistry

Intervention

Procedure:
• Extraction of upper and lower FPM teeth
Extraction of upper and lower FPM teeth
• Extraction of lower FPM tooth
Extraction of lower FPM tooth only

Locations

Country	Name	City	State
United Kingdom	Springfield Community Dental Practive	Arbroath	Angus
United Kingdom	Dumfries & Galloway Royal Infirmary	Dumfries	Dumfries & Galloway
United Kingdom	Dundee Dental School, University of Dundee	Dundee	Tayside
United Kingdom	Kingscross Hospital Community Dental Service	Dundee	Tayside
United Kingdom	Broxden Community Dental Practice	Perth	Tayside

Sponsors (2)

Lead Sponsor	Collaborator
Professor David Bearn	NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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