Halitosis During Active Orthodontic Treatment

Halitosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03901625
• Other study ID #: FPGRP/43734003/316
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2018
• Est. completion date: October 11, 2019

Study information

• Verified date: April 2019
• Source: Riyadh Colleges of Dentistry and Pharmacy
• Contact: Omar H AlKadhi, BDS, MSc
• Phone: +966505154754
• Email: omar.alkadhi[@]riyadh.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 11, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Halitosis

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	Riyadh Elm University	Riyadh	Ar Riyad

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Colleges of Dentistry and Pharmacy

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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