Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth

Trauma Clinical Trial

— FAVOURITE  

Official title:

Efficacy of Adjunctive Juice Plus in Reducing Post-operative Morbidity and Improving Quality of Life After Lower Third Molar Surgery: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145820
• Other study ID #: RG_09-111
• Status: Completed
• Phase: N/A
• First received: June 16, 2010
• Last updated: October 8, 2013
• Start date: June 2010
• Est. completion date: April 2013

Study information

• Verified date: October 2013
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postoperative Morbidity
• Trauma
• Wound Healing

Intervention

Dietary Supplement:
• Juice plus
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)

Locations

Country	Name	City	State
United Kingdom	University of Birmingham	Birmingham	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	NSA, Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	QOL as assessed by PoSSe scale (Ruta et al., 2000)	first postoperative week	No
Secondary	trismus	trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient	postoperative week	No
Secondary	postoperative pain	pain will be assessed by patient on VAS on each postop day. groups will be compared for the following: total (sum) of pain scores over 1 week; proportion of patients reporting >50% pain on day 2 and day 7; time until pain consistently <50%; proportion of patients reporting 20mm increase in pain after postoperative day 3	postoperative week	No
Secondary	analgesic use		first postoperative week	No
Secondary	plasma total antioxidant capacity (TAOC)	group differences between plasma TAOC changes between baseline and 1 week postop	baseline (preop) and 1 week postop	No
Secondary	serum biomarkers of oxidative stress	differences in change from baseline to 1 week of mean protein carbonyls, isoprostanes and 8OHdG	first postoperative week (baseline and 1 week)	No
Secondary	serum concentration of acute phase reactants	change between baseline and 1 week of: CRP, fibrinogen, WBC	first postoperative week	No
Secondary	adverse events		first postoperative week	Yes