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Efficacy of Chewing Sugarless Gum for Reduction of Orthodontic Appliance Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02024139
Recruitment Status : Completed
First Posted : December 31, 2013
Last Update Posted : April 12, 2016
Sponsor:
Information provided by (Responsible Party):
Athbi Alqareer, Kuwait University

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.

Condition or disease Intervention/treatment Phase
Pain Associated With Fixed Orthodontic Treatment Other: Chewing Sugarless Gum Other: Using Mouthwash Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy of Chewing Sugarless Gum for Reduction of Orthodontic Fixed Appliance Activation Pain
Study Start Date : January 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: Chewing Sugarless Gum and Mouthwash
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 Gum
Chewing sugar free gum three times per day for 5-10 minutes
Other Name: Mentos 3D sugar free gum

Other: Using Mouthwash
Rinse mouth with plax sensitive fluoridated mouthwash for 30 seconds, three times per day
Other Name: Place fluoridated mouthwash

Placebo Comparator: Using fluoridated mouthwash
Using Mouthwash: Patients are asked to use a fluoridated mouthwash 3 times per day as a placebo
Other: Using Mouthwash
Rinse mouth with plax sensitive fluoridated mouthwash for 30 seconds, three times per day
Other Name: Place fluoridated mouthwash




Primary Outcome Measures :
  1. Pain scale reading [ Time Frame: 10 days ]
    Patients mark a 100mm visual analog pain scale to rate tooth pain experienced during the first 10 days of their routine orthodontic treatment


Secondary Outcome Measures :
  1. Patient subjective assessment of pain experience [ Time Frame: 10 days ]
    Patients answer subjective questions about pain experience and whether is affects their decision to undergo orthodontic treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • fixed upper and lower orthodontic appliance therapy scheduled

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024139


Locations
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Kuwait
Bneid Algar Dental Speciality Center
Kuwait City, Kuwait, 13110
Sponsors and Collaborators
Kuwait University
Investigators
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Principal Investigator: Athbi Alqareer, BDM, DMSc Kuwait University
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Responsible Party: Athbi Alqareer, Assistant Professor, Kuwait University
ClinicalTrials.gov Identifier: NCT02024139    
Other Study ID Numbers: DD01/13
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016
Keywords provided by Athbi Alqareer, Kuwait University:
Orthodontic pain
Chewing gum