The FAVOURITE Trial: Methods, Recruitment, Retention and Sample Characteristics

Objectives:

The aim of this study is to present the methods, recruitment and sample characteristics of the FAVOURITE trial.

Methods:

The FAVOURITE study is a monocentre, randomised, double blind, placebo controlled, 2 arm clinical trial to investigate the efficacy of adjunctive encapsulated fruit and vegetable powder concentrate (Juice plus®)(F&V) to reduce post-operative morbidity and improving quality of life after lower third molar surgery.

238 patients were screened and randomised to receive placebo or F&V for 11 weeks. Following 10 weeks of supplementation, patients had one lower third molar surgically removed. Post-operative morbidity was assessed over one week by quality of life; pain levels (VAS), amount of painkillers taken and trismus. Blood and saliva samples were collected at all visits

Results:

120 patients were randomised, 71(59%) female to the active and 118, 78(66%) female to the placebo group.

The mean age of the randomised patients was 29.2 years.

Between groups there were no differences with any of the patient characteristics measured at baseline.

45(18%) patients failed to return for surgery and 10(4%) were lost to follow up (LTF) after surgery, with no difference in dropout rate between groups.

Smokers were less likely to return for surgery (P=0.003).

Patients with poor oral hygiene (P=0.001), smokers (P=0.002) and less invasive surgery (P=0.003) were more likely to be LTF post operatively.

Conclusion:

LTF between baseline and surgery was high, with smokers being less likely to return for surgery.

Fewer patients were LTF post-operatively. Oral hygiene, smoking, bone removal and tooth sectioning were predictors of LTF.