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Should I eXtract Every Six dental trial (SIXES): study protocol for a randomized controlled trial.
Nicola Innes1, Felicity Borrie, David Bearn
1Dundee Dental Hospital and School, Park Place, University of Dundee, DD1 4HN, Dundee, UK. n.p.innes@dundee.ac.uk
Trials
|February 28, 2013
Summary
This study compares extracting upper molars with lower molar extractions in children. It aims to reduce unnecessary dental procedures and improve long-term oral health outcomes.
Area of Science:
- Pediatric Dentistry
- Orthodontics
- Oral Surgery
Background:
- Extraction of lower first permanent molars is common in children.
- Clinical guidelines recommend 'compensating extraction' of upper first molars, but practice varies.
- This uncertainty can lead to unnecessary or insufficient extractions, impacting long-term oral health and treatment complexity.
Purpose of the Study:
- To compare the clinical effectiveness and quality of life between conventional treatment (compensating upper molar extraction) and alternative intervention (no upper molar extraction) in children.
- To provide evidence-based guidance for dentists and orthodontists regarding the necessity of compensating extractions.
- To potentially reduce the number of tooth extractions performed in pediatric dental care.
Main Methods:
- A multicenter, two-arm parallel group randomized clinical trial (SIXES trial).
- Recruitment of 400 children aged 7-11 years requiring lower first permanent molar extraction.
- Primary outcome: degree of lower second permanent molar tipping; secondary outcomes: anesthetic use, spacing, orthodontic needs, quality of life, and over-eruption.
Main Results:
- The study is ongoing and results are pending.
- The primary outcome measure is the degree of tipping of the lower second permanent molar.
- Secondary outcome measures include anesthetic type, residual spacing, orthodontic treatment needs, quality of life, and over-eruption.
Conclusions:
- The SIXES trial will investigate the necessity of compensating upper molar extraction after lower molar loss.
- Current decision-making relies on expert opinion, highlighting the need for robust evidence.
- The trial aims to inform clinical practice, potentially leading to fewer unnecessary tooth extractions.
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