NCT02024139

Brief Summary

This study investigates whether chewing sugar-free chewing gum can reduce pain associated with braces treatment. The study collects pain scale records for 10 consecutive days after placement of braces. No changes to patients routine braces treatment is done. All materials used are available over the counter.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

2.2 years

First QC Date

December 26, 2013

Last Update Submit

April 11, 2016

Conditions

Pain Associated With Fixed Orthodontic Treatment

Keywords

Orthodontic painChewing gum

Outcome Measures

Primary Outcomes (1)

  • Pain scale reading

    Patients mark a 100mm visual analog pain scale to rate tooth pain experienced during the first 10 days of their routine orthodontic treatment

    10 days

Secondary Outcomes (1)

  • Patient subjective assessment of pain experience

    10 days

Study Arms (2)

Chewing Sugarless Gum and Mouthwash

EXPERIMENTAL

Patients are asked to chew sugarless gum 3 times per day in addition to using a fluoridated mouthwash 3 times per day

Other: Chewing Sugarless GumOther: Using Mouthwash

Using fluoridated mouthwash

PLACEBO COMPARATOR

Using Mouthwash: Patients are asked to use a fluoridated mouthwash 3 times per day as a placebo

Other: Using Mouthwash

Interventions

Chewing Sugarless GumOTHER

Chewing sugar free gum three times per day for 5-10 minutes

Also known as: Mentos 3D sugar free gum
Chewing Sugarless Gum and Mouthwash
Using MouthwashOTHER

Rinse mouth with plax sensitive fluoridated mouthwash for 30 seconds, three times per day

Also known as: Place fluoridated mouthwash
Chewing Sugarless Gum and MouthwashUsing fluoridated mouthwash

Eligibility Criteria

Age10 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • fixed upper and lower orthodontic appliance therapy scheduled

You may not qualify if:

  • tooth extractions within one week
  • chronic pain
  • regular use of analgesics
  • partial appliance engagement
  • use of extra-oral appliances like headgear
  • patients unable to consume sugarless gum like phenylketonuria patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bneid Algar Dental Speciality Center

Kuwait City, Kuwait, 13110, Kuwait

Location

Study Officials

  • Athbi Alqareer, BDM, DMSc

    Kuwait University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 26, 2013

First Posted

December 31, 2013

Study Start

January 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 12, 2016

Record last verified: 2016-04

Locations

KU(1)