SIXES; Should I eXtract Every Six?
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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? |
- 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.
- 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 |
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| 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 |
| 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 | |
| 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 May 23, 2013