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Halitosis During Active Orthodontic Treatment

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: NCT03901625
Recruitment Status : Unknown
Verified April 2019 by Omar Alkadhi, Riyadh Colleges of Dentistry and Pharmacy.
Recruitment status was:  Recruiting
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Omar Alkadhi, Riyadh Colleges of Dentistry and Pharmacy

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

Condition or disease Intervention/treatment Phase
Halitosis Device: Manual Toothbrush Device: Dental floss Device: Waterjet Device: Electric Toothbrush Not Applicable

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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of Different Methods of Teeth Cleaning on the Levels of Volatile Sulfur Compounds in Patients With Orthodontic Fixed Appliances
Actual Study Start Date : January 13, 2018
Estimated Primary Completion Date : June 6, 2019
Estimated Study Completion Date : October 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bad Breath

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ManualTB+Floss
Cleaning teeth with a manual toothbrush and a dental floss three times a day.
 Device: Manual Toothbrush
A manual toothbrush is used to clean teeth surfaces.

Device: Dental floss
A dental floss is used to clean inter-proximal areas.
Experimental: ManualTB+Waterjet
Cleaning teeth with a manual toothbrush and a waterjet three times a day.
 Device: Manual Toothbrush
A manual toothbrush is used to clean teeth surfaces.

Device: Waterjet
A waterjet is used to clean inter-proximal areas.
Experimental: Electric TB+Floss
Cleaning teeth with an electric toothbrush and dental floss three times a day .
 Device: Dental floss
A dental floss is used to clean inter-proximal areas.

Device: Electric Toothbrush
An electric toothbrush is used to clean teeth surfaces.
Experimental: Electric TB +Waterjet
Cleaning teeth with an electric toothbrush and a waterjet three times a day .
 Device: Waterjet
A waterjet is used to clean inter-proximal areas.

Device: Electric Toothbrush
An electric toothbrush is used to clean teeth surfaces.


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

  2. Change in volatile sulphur compounds causing halitosis at eight weeks. [ Time Frame: 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 Criteria
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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT03901625


Contacts
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Contact: Omar H AlKadhi, BDS, MSc +966505154754 omar.alkadhi@riyadh.edu.sa

Locations
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Saudi Arabia
Riyadh Elm University Recruiting
Riyadh, Ar Riyad, Saudi Arabia, 11681
Contact: Omar AlKadhi         
Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy
More Information
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Responsible Party: Omar Alkadhi, Assistant professor, Riyadh Colleges of Dentistry and Pharmacy
ClinicalTrials.gov Identifier: NCT03901625    
Other Study ID Numbers: FPGRP/43734003/316
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Halitosis
Signs and Symptoms, Digestive