NCT03524703

Brief Summary

The aim of the study is to estimate the effect of chewing gum after anterior cervical fusion surgery on decreasing the severity of dysphagia in patients with mild-moderate dysphagia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 11, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

April 28, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

1.6 years

First QC Date

April 11, 2018

Last Update Submit

May 15, 2018

Conditions

Dysphagia

Keywords

dysphagiaanterior cervical fusionchewing gum

Outcome Measures

Primary Outcomes (1)

  • Dysphagia Short Questionnaire (DSQ) score

    DSQ is designed for the evaluation of swallowing difficulty after anterior cervical spine surgery. It is calculated by summing up the points given for each item, from 0 point to a maximum of 18 points, where lower scores represent milder symptoms and vice versa.

    Change from the 1st day after surgery to the 7th day after surgery.

Secondary Outcomes (2)

  • Bazaz grading system

    Change from the 1st day after surgery to the 7th day after surgery.

  • Prevertebral soft tissue swelling

    The 3rd days after surgery.

Study Arms (2)

Chewing Gum Group

EXPERIMENTAL

Patients who receive anterior cervical fusion and have mild or moderate dysphagia postoperatively, will be randomized into two groups. Subjects assigned to the Chewing Gum Group are asked to chew gum four times a day for 5 days (15 minutes each time) after surgery in addition to standard cares. Standard cares include cleaning the wound every 2 days, wearing a collar, pain management, and education.

Other: chewing gum

Control Group

NO INTERVENTION

Patients who receive anterior cervical fusion and have mild or moderate dysphagia postoperatively, will be randomized into two groups. Subjects assigned to the Control Group receive standard cares and are asked not to chew gum within 5 days after surgery. Standard cares include cleaning the wound every 2 days, wearing a collar, pain management, and education.

Interventions

chewing gumOTHER

Chewing gum four times per day for 5 days, 15 minutes each time.

Chewing Gum Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age from 18 years to 80 years.
  • underwent anterior cervical fusion surgery for degenerative cervical disease.
  • diagnosed with mild or moderate postoperative dysphagia 1 day after surgery using Bazaz scale.

You may not qualify if:

  • Patients underwent revision procedures or procedures treating conditions other than degenerative cervical disease.
  • Patients with preoperative dysphagia.
  • Patients unable to chew, or unable to follow the directions for chewing gum.
  • Patients unable to attend follow-up visits or finish the dysphagia questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Yunbing Chang, M.D., Ph.D.

    Guangdong Provincial People's Hospital

    STUDY CHAIR

Central Study Contacts

Yunbing Chang, M.D., Ph.D.

CONTACT

86-020-83827812cspine@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Spine Department

Study Record Dates

First Submitted

April 11, 2018

First Posted

May 15, 2018

Study Start

April 28, 2018

Primary Completion

November 30, 2019

Study Completion

December 30, 2019

Last Updated

May 18, 2018

Record last verified: 2018-05

Locations

CN(1)