CClinicalTrials.gg
Status unknownNCT03901625Updated Apr 3, 2019

Halitosis During Active Orthodontic Treatment

An interventional study of Manual Toothbrush and Dental floss in Halitosis, sponsored by Riyadh Colleges of Dentistry and Pharmacy. Status unknown at 1 site in Saudi Arabia. Open to participants aged 14 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-04-03.

Sponsored by Riyadh Colleges of Dentistry and Pharmacy · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jan 2018, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
14 Years to 50 Years
Sex
All
01

Study summary

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

Read the 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)

02

Conditions studied

  • Halitosis

Browse trials for

03

In context

Halitosis

88 studies on the registry are indexed under Halitosis; 18 are open to participants now.

This study's planned enrollment of 60 is above the median of 45 across 75 interventional studies indexed under Halitosis.

Browse Halitosis studies →

Lead sponsor

Riyadh Colleges of Dentistry and Pharmacy is the lead sponsor of 27 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. patients with mental retardation.
  2. patients with systematic diseases.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    ManualTB+Floss

    Cleaning teeth with a manual toothbrush and a dental floss three times a day.

    Device: Manual Toothbrush · Device: Dental floss

  • Experimental
    ManualTB+Waterjet

    Cleaning teeth with a manual toothbrush and a waterjet three times a day.

    Device: Manual Toothbrush · Device: Waterjet

  • Experimental
    Electric TB+Floss

    Cleaning teeth with an electric toothbrush and dental floss three times a day .

    Device: Dental floss · Device: Electric Toothbrush

  • Experimental
    Electric TB +Waterjet

    Cleaning teeth with an electric toothbrush and a waterjet three times a day .

    Device: Waterjet · Device: Electric Toothbrush

Interventions

  • DeviceManual Toothbrush

    A manual toothbrush is used to clean teeth surfaces.

  • DeviceDental floss

    A dental floss is used to clean inter-proximal areas.

  • DeviceWaterjet

    A waterjet is used to clean inter-proximal areas.

  • DeviceElectric Toothbrush

    An electric toothbrush is used to clean teeth surfaces.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline then and after four weeks then

  2. 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.

    Time frame: At four weeks from baseline and after eight weeks then

07

Study locations

1 of 1 sites recruiting
  • Riyadh Elm University
    Riyadh, Ar Riyad 11681, Saudi Arabia
    • Omar AlKadhi · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03901625
Lead sponsor
Riyadh Colleges of Dentistry and Pharmacy
Responsible party
Omar Alkadhi (Assistant professor, Riyadh Colleges of Dentistry and Pharmacy) — Principal investigator
First posted
Apr 3, 2019
Start date
Jan 13, 2018
Primary completion
Jun 6, 2019 (estimated)
Completion
Oct 11, 2019 (estimated)
Last update
Apr 3, 2019

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion