Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth

Not Applicable

Completed

• Conditions: Wound Healing; Postoperative Morbidity; Trauma

• Registration Number: NCT01145820
• Lead Sponsor: University of Birmingham

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-08
• Last Update Posted: 2013-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of Life	first postoperative week	QOL as assessed by PoSSe scale (Ruta et al., 2000)

Secondary Outcome Measures

Name	Time	Method
analgesic use	first postoperative week
plasma total antioxidant capacity (TAOC)	baseline (preop) and 1 week postop	group differences between plasma TAOC changes between baseline and 1 week postop
adverse events	first postoperative week
trismus	postoperative week	trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient
postoperative pain	postoperative week	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
serum biomarkers of oxidative stress	first postoperative week (baseline and 1 week)	differences in change from baseline to 1 week of mean protein carbonyls, isoprostanes and 8OHdG
serum concentration of acute phase reactants	first postoperative week	change between baseline and 1 week of: CRP, fibrinogen, WBC

Trial Locations

Locations (1)

University of Birmingham; 🇬🇧 Birmingham, West Midlands, United Kingdom