Should I eXtract Every Six dental trial (SIXES): study protocol for a randomized controlled trial

Abstract

BackgroundExtraction of lower first permanent molars in children is common. There is uncertainty among clinicians as to whether a ‘compensating extraction’ (removal of the upper first permanent molar to prevent it over erupting) is necessary despite current guidelines recommending this. As a result, unnecessary dental extractions may be carried out or children may be failing to receive extractions required to achieve optimal long-term oral health. In addition, the decision to extract fewer or more teeth affects management options (local anesthetic injections alone, inhalation sedation or general anesthesia) needed to support the child with the surgical procedure(s).The SIXES (Should I eXtract Every Six) dental trial investigates clinical effectiveness and quality of life for conventional treatment (following the guideline of compensation extraction of the upper first permanent molar) compared with the alternative intervention (removal of lower first permanent molars but no extraction of the upper).Methods/DesignThis is a multicenter, two-arm parallel group randomized clinical trial. Allocation will be web-based randomization. Practitioners in primary and secondary care settings, reflecting the points of presentation and treatment of eligible patients, will recruit 400 children, aged 7 to 11 years requiring extraction of lower first permanent molars but who have upper first permanent molars of good prognosis. Baseline measures (prior to treatment) and outcome data (at one and five years, or when the patient reaches 14 years of age) will be assessed through study models and child/parent questionnaires.The primary outcome measure is degree of tipping of the lower second permanent molar, (favorable outcome is tipping less than 15°).The secondary outcomes are type of anesthetic/sedation used, residual spacing (between lower second premolar and second permanent molar), orthodontic treatment requirement, quality of life, and over-eruption in the intervention group. Assessors will be blinded where possible.DiscussionSIXES dental trial investigates whether compensating extraction of upper first permanent molars should be carried out following loss of lower first permanent molars. Currently dentists and orthodontists face a dilemma in clinical decision-making, relying on the lowest level of evidence - expert opinion. SIXES will provide evidence to support decision-making and inform practices and may result in reduced tooth extractions.Trial registrationClinical Trials.gov Identifier: NCT01591265

Management of compromised first permanent molars in children: Cross‐Sectional analysis of attitudes of UK general dental practitioners and specialists in paediatric dentistry

“…Specialists and generalists were more likely to compensate non‐affected upper first molars than lower first molars; however, variation within groups still existed. Compensating a maxillary molar is done to avoid over‐eruption of the lower molar, which can prevent desirable mesial movement; however, there is little data to support these claims …”

“…Compensating a maxillary molar is done to avoid overeruption of the lower molar, which can prevent desirable mesial movement; however, there is little data to support these claims. 29,30 It appears GDPs and specialists preferred local anaesthetic alone if the tooth was to be restored. Similarly, local anaesthesia alone was the preferred option for extraction amongst GDPs whereas specialists slightly favoured the general anaesthetic option compared to inhalation sedation and local anaesthetic alone.…”

National clinical guidelines for the extraction of first permanent molars in children

“…[12][13][14] A randomised controlled trial has been registered, which aims to provide more reliable evidence as to whether compensating extraction of upper first permanent molars should be carried out in conjunction with the enforced extraction of lower first permanent molars. 15 When the enforced extraction of a lower first permanent molar is required, consideration should be given toward compensating extraction of the upper first permanent molar if this tooth is likely to remain unopposed for a significant length of time ( Fig. 4).…”

<p>Nanomedicine-based formulations containing &omega;-3 polyunsaturated fatty acids: potential application in cardiovascular and neoplastic diseases</p>

“…This implies that the encapsulation of either DHA or ALA into RV-based SLN could also markedly increase the CRC content of EPA, which, according to several recent reports, seems to protect against CRC risk better than all the other main ω-3 PUFAs. [106][107][108] The more efficient conversion of SLN-encapsulated ALA is particularly interesting when considering that ALA is present at high levels in a variety of seeds and vegetables, and its increased intake could be achieved more easily and in a more sustainable way compared to an increased consumption of EPA itself.…”