SIXES; Should I eXtract Every Six?

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2012 by University of Dundee
Sponsor:
Collaborator:
NHS Tayside
Information provided by (Responsible Party):
Stephen McSwiggan, University of Dundee
ClinicalTrials.gov Identifier:
NCT01591265
First received: April 30, 2012
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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 Intervention
Paediatric Dentistry
Procedure: compensatory extraction of upper FPMs
Procedure: no compensatory extraction of Upper FPMs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SIXES; Should I eXtract Every Six?

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Extent of tipping of the lower second permanent molars [ Time Frame: 5 year ] [ Designated as safety issue: No ]

    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:
  • position of the upper FPMs with regard to over-eruption [ Time Frame: 1 year and 5 year ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: June 2012
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: compensatory extraction of upper FPMs

The only difference in treatment will be related to the FPM extractions (one side only per patient will be entered into the trial). For patients allocated to the Control arm (Group A), both the upper FPM and lower FPM will be extracted.

The control group will have the normal standard intervention according to the current standard guidelines, and will receive routine patient care with the normal practice of compensation extraction.

Procedure: compensatory extraction of upper FPMs
Routine clinical care group who will receive standard therapy of extraction of upper FPMs
Active Comparator: no compensatory extraction
For patients in the Intervention arm (Group B), only the lower FPM will be extracted. Only one side of the mouth will have data collected for the study. The control group will have the normal standard intervention according to the current standard guidelines, and will receive routine patient care with the normal practice of compensation extraction, whilst the intervention group here will have removal of their lower FPMs but no compensation extraction of the upper FPM will be carried out.
Procedure: no compensatory extraction of Upper FPMs
Intervention group: clinical care group who will receive non standard therapy of not extracting the upper FPMs.

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591265

Contacts
Contact: Stephen J McSwiggan, BSc(Hons) RN +44 (0) 1382740136 s.j.mcswiggan@dundee.ac.uk
Contact: Felicity RP Borrie, M Orth MFDS +44 (0) 1382635992 f.borrie@dundee.ac.uk

Locations
United Kingdom
Dundee Dental School, University of Dundee Not yet recruiting
Dundee, Angus, United Kingdom, DD1 9SY
Principal Investigator: Felicity Borrie, M Orth, MFDS         
Sub-Investigator: Nicola Innes, PhD MFDS         
Sub-Investigator: David Bearn, PhD MOrth         
Sub-Investigator: Dafyyd Evans, PhD FDS         
Sponsors and Collaborators
Stephen McSwiggan
NHS Tayside
Investigators
Principal Investigator: Felicity RP Borrie, MOrth MFDS University of Dundee
Principal Investigator: Nicola Innes, PhD, MFDS, University of Dundee
Principal Investigator: David Bearn, PhD MILT FDS University of Dundee
Principal Investigator: Dafyyd Evans, PHD FDS University of Dundee
  More Information

No publications provided by University of Dundee

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen McSwiggan, Senior Trials Manager, University of Dundee
ClinicalTrials.gov Identifier: NCT01591265     History of Changes
Other Study ID Numbers: 2011DE02
Study First Received: April 30, 2012
Last Updated: May 1, 2012
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on July 20, 2014