Halitosis During Active Orthodontic Treatment

NCT03901625 — Not applicable, Unknown, 60 participants, Riyadh Colleges of Dentistry and Pharmacy

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The Efficacy of Different Methods of Teeth Cleaning on the Levels of Volatile Sulfur Compounds in Patients With Orthodontic Fixed Appliances

Registry	NCT03901625
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	60 (Estimated)
Sponsor	Riyadh Colleges of Dentistry and Pharmacy (Other)
Conditions	Halitosis
Interventions	Manual Toothbrush, Dental floss, Waterjet, Electric Toothbrush (Device)
Dates	start 2018-01-13, primary completion 2019-06-06 (estimated), completion 2019-10-11 (estimated), first posted 2019-04-03, last updated 2019-04-03
Locations	1 site in Saudi Arabia

-Summary

To determine the effect of different cleaning methods and devices in reducing halitosis during active orthodontic treatment.

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+Detailed description

. Observer - blind clinical trial, randomly divided into four groups, A, B, C and D. each group will undergo clinical evaluation and oral malodor assessment and they will be assigned electric or manual toothbrushes with super floss or water floss respectively.clinical evaluation will include plaque index (PI), gingival bleeding index (GBI), bracket index.and halitosis will be measured by halimeter .

Measurements and time frame: Initial measurements (T0), after two weeks (T1), and after four weeks (T2) ( according to previous studies that uses the same period of time for measurements),17, 18 plaque index (PI), gingival bleeding index (GBI), bracket index and halimeter reading .

During the first week after the start of the study (T0)

+Arms and interventions

Arm	Type	Interventions	Description
ManualTB+Floss	Active comparator	Device: Manual Toothbrush; Device: Dental floss	Cleaning teeth with a manual toothbrush and a dental floss three times a day.
ManualTB+Waterjet	Experimental	Device: Manual Toothbrush; Device: Waterjet	Cleaning teeth with a manual toothbrush and a waterjet three times a day.
Electric TB+Floss	Experimental	Device: Dental floss; Device: Electric Toothbrush	Cleaning teeth with an electric toothbrush and dental floss three times a day .
Electric TB +Waterjet	Experimental	Device: Waterjet; Device: Electric Toothbrush	Cleaning teeth with an electric toothbrush and a waterjet three times a day .

Manual Toothbrush (Device): A manual toothbrush is used to clean teeth surfaces.
Dental floss (Device): A dental floss is used to clean inter-proximal areas.
Waterjet (Device): A waterjet is used to clean inter-proximal areas.
Electric Toothbrush (Device): An electric toothbrush is used to clean teeth surfaces.

+Outcome measures

Primary outcomes

Change in volatile sulphur compounds causing halitosis at four weeks. [At baseline then and after four weeks then]: Tanita Breath Checker HC-312SF Fitscan to measures volatile sulphur compounds with six levels of odor.
Change in volatile sulphur compounds causing halitosis at eight weeks. [At four weeks from baseline and after eight weeks then]: Tanita Breath Checker HC-312SF Fitscan to measures volatile sulphur compounds with six levels of odor.

+Eligibility

Sex: All, ages: 14 Years to 50 Years

Inclusion Criteria:

1. participants with fixed orthodontic appliance.
2. participants age 14 years and above and didn't have mental of physical disabilities.
3. participants willing to comply with given oral hygiene instructions.

Exclusion Criteria:

1. patients with mental retardation.
2. patients with systematic diseases.

+Locations (1)

Facility	City	Country	Status
Riyadh Elm University	Riyadh, Riyadh Region	Saudi Arabia	Recruiting