CClinicalTrials.gg
Status unknownNCT03524703Updated May 18, 2018

Short-term Effect of Chewing Gum in Patients With Mild-moderate Dysphagia After Anterior Cervical Fusion

An interventional study of chewing gum in Dysphagia, sponsored by Guangdong Provincial People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-05-18.

Sponsored by Guangdong Provincial People's Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

Postoperative dysphagia is the most common complication of anterior cervical fusion surgery. Previous studies showed that chewing gum helped to improve swallow frequency and latency. However, its short-term effect on alleviating dysphagia symptom after anterior cervical surgery is still unknown. A randomized, parallel controlled, superiority trial is performed in patients with postoperative mild-moderate dysphagia. Dysphagia severity will be assessed using dysphagia short questionnaire (DSQ) score in the chewing gum group and control group during 7 days after surgery, and the changes in DSQ score between two groups will be compared, to estimate the effect of chewing gum on alleviating dysphagia symptom.

02

Conditions studied

  • Dysphagia

Browse trials for

Keywords

  • dysphagia
  • anterior cervical fusion
  • chewing gum
03

In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's planned enrollment of 90 is above the median of 60 across 471 interventional studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

Guangdong Provincial People's Hospital is the lead sponsor of 231 studies on the registry; 101 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Chewing Gum Group

    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

  • No intervention
    Control Group

    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

  • Otherchewing gum

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

06

What researchers measure

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.

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

Secondary outcomes

  1. Bazaz grading system

    Bazaz grading system is designed for the evaluation of swallowing difficulty after anterior cervical spine surgery. The patients are graded as having none, mild, moderate, or severe dysphagia based on their symptoms. A none or mild dysphagia is considered to be a better outcome.

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

  2. Prevertebral soft tissue swelling

    The measurement of the soft tissue space is made on the line parallel to the upper end plate from the midpoint of the anterior surface of each vertebral body to the border of the airway shadow. This scale ranges from 0 to approximately 30 mm for each vertebra, where a lower value represents a milder soft tissue swelling.

    Time frame: The 3rd days after surgery.

07

Study locations

1 of 1 sites recruiting
  • Guangdong General Hospital
    Guangzhou, Guangdong 510080, China
    • Yunbing Chang, M.D., Ph.D. · Contact · cspine@qq.com · 086-020-83827812
    • Guoyan Liang, M.D., Ph.D. · Contact · 410330757@qq.com · 086-020-83827812
    Recruiting
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 27, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03524703
Lead sponsor
Guangdong Provincial People's Hospital
Responsible party
YunBing Chang (Head of Spine Department, Guangdong Provincial People's Hospital) — Principal investigator
First posted
May 15, 2018
Start date
Apr 28, 2018
Primary completion
Nov 30, 2019 (estimated)
Completion
Dec 30, 2019 (estimated)
Last update
May 18, 2018

Study contacts

Yunbing Chang, M.D., Ph.D.
Contact
cspine@qq.com
86-020-83827812 ext. 61011
Yunbing Chang, M.D., Ph.D.
study chair · Guangdong Provincial People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion