Halitosis During Active Orthodontic Treatment

Not Applicable

• Conditions: Halitosis
• Interventions: Device: Manual Toothbrush; Device: Dental floss; Device: Electric Toothbrush; Device: Waterjet

• Registration Number: NCT03901625
• Lead Sponsor: Riyadh Colleges of Dentistry and Pharmacy

Brief Summary

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

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 Timeline

• Study Start: 2018-01-13
• Status Verified: 2019-04
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-01
• Last Update Submitted: 2019-04-01
• Study First Posted: 2019-04-03
• Last Update Posted: 2019-04-03
• Primary Completion: 2019-06-06
• Study Completion: 2019-10-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ManualTB+Floss	Dental floss	Cleaning teeth with a manual toothbrush and a dental floss three times a day.
Electric TB+Floss	Dental floss	Cleaning teeth with an electric toothbrush and dental floss three times a day .
ManualTB+Floss	Manual Toothbrush	Cleaning teeth with a manual toothbrush and a dental floss three times a day.
Electric TB +Waterjet	Electric Toothbrush	Cleaning teeth with an electric toothbrush and a waterjet three times a day .
ManualTB+Waterjet	Waterjet	Cleaning teeth with a manual toothbrush and a waterjet three times a day.
ManualTB+Waterjet	Manual Toothbrush	Cleaning teeth with a manual toothbrush and a waterjet three times a day.
Electric TB +Waterjet	Waterjet	Cleaning teeth with an electric toothbrush and a waterjet three times a day .
Electric TB+Floss	Electric Toothbrush	Cleaning teeth with an electric toothbrush and dental floss three times a day .

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Riyadh Elm University; 🇸🇦 Riyadh, Ar Riyad, Saudi Arabia