Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth (FAVOURITE)

University of Birmingham

Status: Completed

Conditions: Postoperative Morbidity; Trauma; Wound Healing

Treatments: Dietary Supplement: Juice plus

Study type: Interventional

Funder types: Other

Identifiers

NCT01145820

RG_09-111

Details and patient eligibility

About

The proposed study will test the following hypotheses:

1. Pre-operative daily dual supplementation with Juice Plus+ (fruit & vegetable) for 11 weeks will result in reduced post-operative morbidity in terms of quality of life, pain and trismus after 1 week following surgical removal of lower third molars, when compared to placebo.
2. Pre-operative daily dual supplementation with Juice Plus+ (fruit & vegetable) for 11 weeks will reduce serum markers of oxidative stress, following surgical removal of lower third molars, when compared with placebo.

Full description

In general antioxidant status appears to influence wound healing in humans and in animal models of acute trauma, with low antioxidant concentrations and excessive oxidative stress being associated with impaired healing. Whilst antioxidant supplementation has been reported to improve plasma antioxidant status and wound healing in animal models of acute trauma, there is remarkably little data from human studies.

The use of Juice Plus+ has been reported to increase serum concentrations of important antioxidants and reduce serum markers of oxidative stress. However, to date there are no reported studies concerning the potential for Juice Plus+ to improve patient-based outcome measures following the surgical removal of lower third molars. This study therefore proposes to investigate the impact of daily supplementation with Juice Plus+, in improving outcomes following surgical trauma. While the rationale for the proposed study is primarily predicated on the established role of oxidative stress and antioxidant micronutrients in chronic inflammatory diseases, the proposed randomized controlled clinical study represents an efficient way of evaluating the potential for adjunctive Juice Plus+ use in improving wound healing and reducing post-operative morbidity following surgical procedures on humans.

Enrollment: 246 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient requiring surgical removal of a single (unilateral) mandibular wisdom tooth
2. Tooth requiring full mucoperiosteal flap to be raised for removal
3. Bone removal necessary during procedure.

Exclusion criteria

1. Patients refusing to give written informed consent
2. Clinically significant or unstable physical or mental disability rendering the participants incapable of complying with the study protocol as judged by the investigator
3. Pregnant or breast-feeding women
4. Patients taking long term anti-microbial or anti-inflammatory drugs
5. Patients unable to swallow Juice Plus capsules
6. Patients taking regular vitamin or mineral supplementation
7. Patients requiring pre-operative antibiotics for surgery
8. Patients requiring concomitant extractions or contralateral lower 3rd molar removal
9. Allergic to any of the ingredients contained in supplements or placebo medication.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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246 participants in 2 patient groups, including a placebo group

Juice Plus

Experimental group

Treatment:

Dietary Supplement: Juice plus

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Juice plus