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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 : May 14, 2018
Sponsor:
Collaborator:
NHS Tayside
Information provided by (Responsible Party):
Professor David Bearn, University of Dundee

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 conventional treatment where current guidance is followed and extraction of the upper FPM is carried out, compared with the intervention where there is no compensation extraction of the upper FPM following extraction of the lower FPM.

Study objectives: 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.


Condition or disease Intervention/treatment Phase
Paediatric Dentistry Procedure: Extraction of upper and lower FPM teeth Procedure: Extraction of lower FPM tooth Not Applicable

Detailed Description:

The study has been designed as a randomised controlled clinical trial. The control group will have the normal standard intervention : (Group A), and will receive routine patient care with the normal practice of compensation extraction, whilst the intervention group, (Group B) will have removal of their FPMs but no compensation 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.

INCLUSION CRITERIA Age: 7 -11 years Dental History: Able to co-operate with dental treatment Social History Child and carer able to understand study documentation and to participate in study Dental condition: One or two lower FPMs requiring extraction Upper FPMs are sound or restorable with good long term prognosis EXCLUSION CRITERIA Medical History: Medical contraindication to dental extractions Dental condition: Hypodontia in upper arch Previous loss or poor prognosis of other permanent teeth in upper arch Class III skeletal relationship

Patients enrolled in the study will all be dental hospital patients. They therefore will have dental notes in the clinic Kodak R4 system. This will act as source data for 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

The charts for the purposes of the study will be on paper, the charts and patient questionnaires will be annonymised and coded.

At subsequent 1 year and five year review visits dental study 3D models will be repeated, charted and again added to the CRF together with the COHQoL questionnaire for that visit.

The charts and questionnaire will all be marked with the patient's unique study ID number which will be linked to the enrolment log for the trial.

All data will be collected from the clinics at least monthly by the research team and transferred to the Health Informatics Centre for storage, date entry and ultimately analysis.

Participants who do not attend for a review visit will be contacted by the clinic and offered another appointment. If they subsequently fail to attend then the questionnaire will be mailed out with a prepaid envelope and a note sent to the trials team from the clinic to explain the patient has been lost to follow-up.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
United Kingdom
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
Sponsors and Collaborators
Professor David Bearn
NHS Tayside
Investigators
Principal Investigator: David R Bearn, MOrth MFDS University of Dundee
Principal Investigator: Nicola Innes, PhD, MFDS, University of Dundee

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor David Bearn, Cheif Investigator, University of Dundee
ClinicalTrials.gov Identifier: NCT01591265     History of Changes
Other Study ID Numbers: 2011DE02
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Keywords provided by Professor David Bearn, University of Dundee:
Compensatory dental extraction
Children 7-11 years old