HalitosisNCT03901625
Halitosis During Active Orthodontic Treatment
A study testing Manual Toothbrush, Dental floss and Waterjet in people with Halitosis, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
Trial summary
To determine the effect of different cleaning methods and devices in reducing halitosis during active orthodontic treatment. Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- Halitosis
- What is being tested?
- Manual Toothbrush, Dental floss and Waterjet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 13 Jan 2018to 11 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- participants with fixed orthodontic appliance.
- participants age 14 years and above and didn't have mental of physical disabilities.
- participants willing to comply with given oral hygiene instructions.
Who cannot join
- patients with mental retardation.
- patients with systematic diseases.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Riyadh Elm University
Riyadh, Riyadh Region, 11681
Omar AlKadhi
About this study
Official title: 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.
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)
- Conditions
- Halitosis
- Being tested
- Manual Toothbrush, Dental floss, Waterjet, Electric Toothbrush
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual ToothbrushDevice
A manual toothbrush is used to clean teeth surfaces.
Dental flossDevice
A dental floss is used to clean inter-proximal areas.
WaterjetDevice
A waterjet is used to clean inter-proximal areas.
Electric ToothbrushDevice
An electric toothbrush is used to clean teeth surfaces.
| Study group | Role | What they receive |
|---|---|---|
| ManualTB+Floss | Active comparator | Cleaning teeth with a manual toothbrush and a dental floss three times a day. Receives: Device: Manual Toothbrush; Device: Dental floss |
| ManualTB+Waterjet | Experimental | Cleaning teeth with a manual toothbrush and a waterjet three times a day. Receives: Device: Manual Toothbrush; Device: Waterjet |
| Electric TB+Floss | Experimental | Cleaning teeth with an electric toothbrush and dental floss three times a day . Receives: Device: Dental floss; Device: Electric Toothbrush |
| Electric TB +Waterjet | Experimental | Cleaning teeth with an electric toothbrush and a waterjet three times a day . Receives: Device: Waterjet; Device: Electric Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline then and after four weeks then
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.
Measured: At four weeks from baseline and after eight weeks then
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start13 Jan 2018
- Primary completion6 Jun 2019 (estimated)
- Study completion11 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HalitosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Alkadhi, Riyadh Colleges of Dentistry and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901625
- Sponsor's protocol ID
- FPGRP/43734003/316
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Different Methods of Teeth Cleaning on the Levels of Volatile Sulfur Compounds in Patients With Orthodontic Fixed Appliances
- ClinicalTrials.gov ID
- NCT03901625
- Acronym / sponsor ID
- FPGRP/43734003/316
- Conditions
- Halitosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- 13 Jan 2018 (actual)
- Primary completion
- 6 Jun 2019 (estimated)
- Study completion
- 11 Oct 2019 (estimated)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ManualTB+Floss | Active comparator | Device: Manual Toothbrush, Device: Dental flossCleaning teeth with a manual toothbrush and a dental floss three times a day. |
| ManualTB+Waterjet | Experimental | Device: Manual Toothbrush, Device: WaterjetCleaning teeth with a manual toothbrush and a waterjet three times a day. |
| Electric TB+Floss | Experimental | Device: Dental floss, Device: Electric ToothbrushCleaning teeth with an electric toothbrush and dental floss three times a day . |
| Electric TB +Waterjet | Experimental | Device: Waterjet, Device: Electric ToothbrushCleaning teeth with an electric toothbrush and a waterjet three times a day . |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- participants with fixed orthodontic appliance.
- participants age 14 years and above and didn't have mental of physical disabilities.
- participants willing to comply with given oral hygiene instructions.
Key exclusion criteria (2 listed)
- patients with mental retardation.
- patients with systematic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual ToothbrushA manual toothbrush is used to clean teeth surfaces. | Device | ManualTB+Floss, ManualTB+Waterjet |
| Dental flossA dental floss is used to clean inter-proximal areas. | Device | Electric TB+Floss, ManualTB+Floss |
| WaterjetA waterjet is used to clean inter-proximal areas. | Device | Electric TB +Waterjet, ManualTB+Waterjet |
| Electric ToothbrushAn electric toothbrush is used to clean teeth surfaces. | Device | Electric TB +Waterjet, Electric TB+Floss |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Toothbrush, Dental floss and Waterjet in people with Halitosis, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar H AlKadhi, BDS, MSc (+966505154754, omar.alkadhi@riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in volatile sulphur compounds causing halitosis at four weeks. (time frame: At baseline then and after four weeks then). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019; AzTrials last refreshed its copy on 30 Oct 2026.