Halitosis During Active Orthodontic Treatment

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

Detailed Description
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. 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)

Official Title
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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

Conditions
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Halitosis

Intervention / Treatment
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* Device: Manual Toothbrush
* Device: Dental floss
* Device: Waterjet
* Device: Electric Toothbrush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: patients with mental retardation. patients with systematic diseases.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ManualTB+Floss<br>Cleaning teeth with a manual toothbrush and a dental floss three times a day. | Device: Manual Toothbrush<br>* A manual toothbrush is used to clean teeth surfaces.<br>Device: Dental floss<br>* A dental floss is used to clean inter-proximal areas.<br>|
| Experimental: ManualTB+Waterjet<br>Cleaning teeth with a manual toothbrush and a waterjet three times a day. | Device: Manual Toothbrush<br>* A manual toothbrush is used to clean teeth surfaces.<br>Device: Waterjet<br>* A waterjet is used to clean inter-proximal areas.<br>|
| Experimental: Electric TB+Floss<br>Cleaning teeth with an electric toothbrush and dental floss three times a day . | Device: Dental floss<br>* A dental floss is used to clean inter-proximal areas.<br>Device: Electric Toothbrush<br>* An electric toothbrush is used to clean teeth surfaces.<br>|
| Experimental: Electric TB +Waterjet<br>Cleaning teeth with an electric toothbrush and a waterjet three times a day . | Device: Waterjet<br>* A waterjet is used to clean inter-proximal areas.<br>Device: Electric Toothbrush<br>* An electric toothbrush is used to clean teeth surfaces.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |