Fruit And Vegetables and OUtcomes After Removal of Impact... | NCT01145820

Studies
Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth

NCT01145820

Sponsor

University of Birmingham

Status

Completed

Last Update Posted

Oct 9, 2013Estimated

Enrollment

246Actual

Phase

Not Applicable

Conditions

Postoperative Morbidity
Trauma
Wound Healing

Interventions

Juice plus

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Jun 16, 2010

First Submission Date that Met QC Criteria

Jun 16, 2010

First Posted Date

Jun 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2013

Last Update Posted Date

Oct 9, 2013Estimated

Name	Class
NSA, Inc	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The proposed study will test the following hypotheses:

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.
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

246Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Juice Plus	Experimental		Dietary Supplement: Juice plus
Placebo	Placebo Comparator		Dietary Supplement: Juice plus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Juice plus	Dietary Supplement	Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)	Juice Plus Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
trismus	trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient	postoperative week
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Dietrich, DMD, MD, MPH	University of Birmingham	Principal Investigator
Iain Chapple, BDS, PhD	Unversity of Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Birmingham		Birmingham	West Midlands	B18 4DA	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28866140	Derived	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.

ID	Term
D014947	Wounds and Injuries
D010146	Pain

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms