Halitosis During Active Orthodontic Treatment

April 1, 2019 updated by: Omar Alkadhi, Riyadh Colleges of Dentistry and Pharmacy

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

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

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Saudi Arabia
    • Ar Riyad
      • Riyadh, Ar Riyad, Saudi Arabia, 11681
        • Recruiting
        • Riyadh Elm University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline then and after four weeks then
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.
At four weeks from baseline and after eight weeks then

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riyadh Colleges of Dentistry and Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 13, 2018

Primary Completion (ANTICIPATED)

June 6, 2019

Study Completion (ANTICIPATED)

October 11, 2019

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (ACTUAL)

April 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 3, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPGRP/43734003/316

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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