Halitosis During Active Orthodontic Treatment
The Efficacy of Different Methods of Teeth Cleaning on the Levels of Volatile Sulfur Compounds in Patients With Orthodontic Fixed Appliances
1 other identifier
interventional
60
1 country
1
Brief Summary
To determine the effect of different cleaning methods and devices in reducing halitosis during active orthodontic treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
1 active site
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
Study Start
First participant enrolled
January 13, 2018
CompletedFirst Submitted
Initial submission to the registry
April 1, 2019
CompletedFirst Posted
Study publicly available on registry
April 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2019
CompletedApril 3, 2019
April 1, 2019
1.4 years
April 1, 2019
April 1, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Change in volatile sulphur compounds causing halitosis at four weeks.
Tanita Breath Checker HC-312SF Fitscan to measures volatile sulphur compounds with six levels of odor.
At baseline then and after four weeks then
Change in volatile sulphur compounds causing halitosis at eight weeks.
Tanita Breath Checker HC-312SF Fitscan to measures volatile sulphur compounds with six levels of odor.
At four weeks from baseline and after eight weeks then
Study Arms (4)
ManualTB+Floss
ACTIVE COMPARATORCleaning teeth with a manual toothbrush and a dental floss three times a day.
ManualTB+Waterjet
EXPERIMENTALCleaning teeth with a manual toothbrush and a waterjet three times a day.
Electric TB+Floss
EXPERIMENTALCleaning teeth with an electric toothbrush and dental floss three times a day .
Electric TB +Waterjet
EXPERIMENTALCleaning teeth with an electric toothbrush and a waterjet three times a day .
Interventions
A manual toothbrush is used to clean teeth surfaces.
A dental floss is used to clean inter-proximal areas.
A waterjet is used to clean inter-proximal areas.
An electric toothbrush is used to clean teeth surfaces.
Eligibility Criteria
You may qualify if:
- participants with fixed orthodontic appliance.
- participants age 14 years and above and didn't have mental of physical disabilities.
- participants willing to comply with given oral hygiene instructions.
You may not qualify if:
- patients with mental retardation.
- patients with systematic diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Riyadh Elm University
Riyadh, Riyadh Region, 11681, Saudi Arabia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
April 1, 2019
First Posted
April 3, 2019
Study Start
January 13, 2018
Primary Completion
June 6, 2019
Study Completion
October 11, 2019
Last Updated
April 3, 2019
Record last verified: 2019-04