NCT01145820

Brief Summary

The proposed study will test the following hypotheses:

  1. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

2.8 years

First QC Date

June 16, 2010

Last Update Submit

October 8, 2013

Conditions

Postoperative MorbidityTraumaWound Healing

Keywords

third molartraumapainwound healingpost operative morbidityacute traumashort-term wound healing

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    QOL as assessed by PoSSe scale (Ruta et al., 2000)

    first postoperative week

Secondary Outcomes (7)

  • trismus

    postoperative week

  • postoperative pain

    postoperative week

  • analgesic use

    first postoperative week

  • plasma total antioxidant capacity (TAOC)

    baseline (preop) and 1 week postop

  • serum biomarkers of oxidative stress

    first postoperative week (baseline and 1 week)

  • +2 more secondary outcomes

Study Arms (2)

Juice Plus

EXPERIMENTAL
Dietary Supplement: Juice plus

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Juice plus

Interventions

Juice plusDIETARY_SUPPLEMENT

Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)

Juice PlusPlacebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Birmingham

Birmingham, West Midlands, B18 4DA, United Kingdom

Location

Related Publications (1)

  • Gorecki P, Burke DL, Chapple ILC, Hemming K, Saund D, Pearson D, Stahl W, Lello R, Dietrich T. Perioperative supplementation with a fruit and vegetable juice powder concentrate and postsurgical morbidity: A double-blind, randomised, placebo-controlled clinical trial. Clin Nutr. 2018 Oct;37(5):1448-1455. doi: 10.1016/j.clnu.2017.08.004. Epub 2017 Aug 10.

    PMID: 28866140DERIVED

MeSH Terms

Conditions

Wounds and InjuriesPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Dietrich, DMD, MD, MPH

    University of Birmingham

    PRINCIPAL INVESTIGATOR

  • Iain Chapple, BDS, PhD

    Unversity of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 16, 2010

First Posted

June 17, 2010

Study Start

June 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 9, 2013

Record last verified: 2013-10

Locations

GB(1)