Efficacy of Chewing Sugarless Gum for Reduction of Orthodontic Appliance Pain

• Register: ClinicalTrials.gov
• Last refreshed on: 25 April 2016
• Main ID: NCT02024139
• Date of registration: 26/12/2013
• Prospective Registration: Yes
• Primary sponsor: Kuwait University
• Public title: Efficacy of Chewing Sugarless Gum for Reduction of Orthodontic Appliance Pain
• Scientific title: Efficacy of Chewing Sugarless Gum for Reduction of Orthodontic Fixed Appliance Activation Pain
• Date of first enrolment: January 2014
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02024139
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care
• Phase: N/A

Countries of recruitment

Kuwait

Contacts

• Name: Athbi Alqareer, BDM, DMSc
• Affiliation: Kuwait University

Key inclusion & exclusion 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



Age minimum: 10 Years
Age maximum: 35 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pain Associated With Fixed Orthodontic Treatment

Intervention(s)

Other: Chewing Sugarless Gum

Other: Using Mouthwash

Primary Outcome(s)

Pain scale reading [Time Frame: 10 days]

Secondary Outcome(s)

Patient subjective assessment of pain experience [Time Frame: 10 days]

Secondary ID(s)

DD01/13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors