Paediatric DentistrySIXESNCT01591265
SIXES: Should I eXtract Every Six? A Study of the Extraction of Permanent Molar Teeth in Children.
A study testing Extraction of upper and lower FPM teeth and Extraction of lower FPM tooth in people with Paediatric Dentistry, run by Professor David Bearn at 5 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Paediatric Dentistry
- What is being tested?
- Extraction of upper and lower FPM teeth and Extraction of lower FPM tooth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- May 2014to 25 Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Springfield Community Dental Practive
Arbroath, Angus, DD11
Dumfries & Galloway Royal Infirmary
Dumfries, Dumfries & Galloway, DG1 4AP
Dundee Dental School, University of Dundee
Dundee, Tayside, DD1 9SY
Kingscross Hospital Community Dental Service
Dundee, Tayside, DD3 8EA DD3 8EA
Broxden Community Dental Practice
Perth, Tayside, PH1 1TJ
About this study
Official title: SIXES: Should I eXtract Every Six? A Randomized Clinical Trial of the Extraction of First Permanent Molar Teeth in Children
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.
Read the 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.
- Conditions
- Paediatric Dentistry
- Being tested
- Extraction of upper and lower FPM teeth, Extraction of lower FPM tooth
- Keywords
- Compensatory dental extraction, Children 7-11 years old
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraction of upper and lower FPM teethProcedure or surgery
Extraction of upper and lower FPM teeth
Extraction of lower FPM toothProcedure or surgery
Extraction of lower FPM tooth only
| Study group | Role | What they receive |
|---|---|---|
| Compensatory Extraction | Active comparator | Patients allocated to this group, both the upper FPM and lower FPM teeth will be extracted. Receives: Procedure: Extraction of upper and lower FPM teeth |
| No Compensatory Extraction | Active comparator | Patients allocated to this group, only the lower FPM tooth will be extracted. Receives: Procedure: Extraction of lower FPM tooth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 year
Secondary outcomes (6)
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.
Measured: 1 year and 5 year
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.
Measured: 1 year and 5 year
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.
Measured: 1 year and 5 year
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.
Measured: at baseline only
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.
Measured: 1 year and 5 year
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.
Measured: 1 year and 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startMay 2014
- Primary completion25 Mar 2015
- Study completion25 Mar 2015
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paediatric DentistryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor David Bearn
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Tayside
- Responsible party
- Sponsor-investigator, Professor David Bearn, University of Dundee
- Investigators
- David R Bearn, MOrth MFDS, Principal investigator, University of DundeeNicola Innes, PhD, MFDS,, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591265
- Sponsor's protocol ID
- 2011DE02
- Acronym
- SIXES
- Status last verified
- Jun 2018
- First submitted
- 30 Apr 2012
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Innes N, Borrie F, Bearn D, Evans D, Rauchhaus P, McSwiggan S, Page LF, Hogarth F. Should I eXtract Every Six dental trial (SIXES): study protocol for a randomized controlled trial. Trials. 2013 Feb 27;14:59. doi: 10.1186/1745-6215-14-59.
PubMed 23442547
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIXES: Should I eXtract Every Six? A Randomized Clinical Trial of the Extraction of First Permanent Molar Teeth in Children
- ClinicalTrials.gov ID
- NCT01591265
- Acronym / sponsor ID
- SIXES / 2011DE02
- Conditions
- Paediatric Dentistry
- Keywords
- Compensatory dental extraction, Children 7-11 years old
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Professor David BearnUniversity, hospital or other
- Collaborators
- NHS Tayside
- Study start
- May 2014
- Primary completion
- 25 Mar 2015 (actual)
- Study completion
- 25 Mar 2015 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compensatory Extraction | Active comparator | Procedure: Extraction of upper and lower FPM teethPatients allocated to this group, both the upper FPM and lower FPM teeth will be extracted. |
| No Compensatory Extraction | Active comparator | Procedure: Extraction of lower FPM toothPatients allocated to this group, only the lower FPM tooth will be extracted. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
- One or two lower FPMs requiring extraction
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extraction of upper and lower FPM teethExtraction of upper and lower FPM teeth | Procedure or surgery | Compensatory Extraction |
| Extraction of lower FPM toothExtraction of lower FPM tooth only | Procedure or surgery | No Compensatory Extraction |
Primary outcome
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.
6 secondary outcomes
position of the upper FPMs with regard to over-eruption
Time frame: 1 year and 5 year
residual spacing between the lower second permanent molar and the lower second premolar*;
Time frame: 1 year and 5 year
American Board of Orthodontics (ABO) scores
Time frame: 1 year and 5 year
the type of anaesthetic used during procedures
Time frame: at baseline only
dental or orthodontic treatment carried out during the follow-up period
Time frame: 1 year and 5 year
Child and Parent Oral Health Related Quality of Life (OHRQoL) scores
Time frame: 1 year and 5 year
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Derived from this study: PubMed 23442547Innes N, Borrie F, Bearn D, Evans D, Rauchhaus P, McSwiggan S, Page LF, Hogarth F. Should I eXtract Every Six dental trial (SIXES): study protocol for a randomized controlled trial. Trials. 2013 Feb 27;14:59. doi: 10.1186/1745-6215-14-59.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Bearn, MOrth MFDS principal investigator
University of Dundee
Nicola Innes, PhD, MFDS, principal investigator
University of Dundee
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extraction of upper and lower FPM teeth and Extraction of lower FPM tooth in people with Paediatric Dentistry, run by Professor David Bearn at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of tipping of the lower second permanent molars (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01591265, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.