Stain Removal EfficacyNCT03140436
Clinical Comparison of the Stain Removal Efficacy of Two Air Polishing Powders
A study testing sodium bicarbonate powders with grain size 65 µm and sodium bicarbonate powders with grain size 40 µm in people with Stain Removal Efficacy, run by Mahidol University at 1 site in Thailand.
Trial summary
This study was designed to find out the stain removal efficacy and also, to find out the operators and patients opinion when use or receive treatment with both air polishing powders. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stain Removal Efficacy
- What is being tested?
- sodium bicarbonate powders with grain size 65 µm and sodium bicarbonate powders with grain size 40 µm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2016to Aug 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy subjects who aged over 18 years old.
- Subjects who have healthy periodontal health or gingivitis.
- At least 3 upper teeth (anterior, premolar and molar) are presented on both side (right \& left side), which will be refer as index teeth, that did not present with any gingival recession, cervical abrasion and/or abfraction, caries, restoration or orthodontic appliance.
- Intrinsic stain is not present.
- Index teeth are presented with extrinsic stain with individual Lobene score scored 2 or above.
Who cannot join
- Pregnancy or current breastfeeding mother.
- Allergy to sodium bicarbonate or the aroma of the powder
Trial locations and contacts
1 site in 1 country.
About this study
This study was designed to find out the stain removal efficacy and also, to find out the operators and patients opinion when use or receive treatment with both air polishing powders.
Read the detailed description
Using air polishing with sodium bicarbonate powders with grain size 65 µm provides efficacy in the removal of dental stains but it can cause gingival trauma if used towards the gingiva. Since having big size particles is uncomfortable, the current recommendation according to literature is to use a smaller grain size (40 µm) that results in more patient comfort. However, the efficacy of small grain size on stain removal has not been studied adequately. This study aimed to compare the stain removal efficacy between sodium bicarbonate powders with grain size 65 µm and 40 µm and also to evaluate patient's acceptance after treatment and operator's opinion after using both air polishing powders.
- Conditions
- Stain Removal Efficacy
- Being tested
- sodium bicarbonate powders with grain size 65 µm, sodium bicarbonate powders with grain size 40 µm
- Keywords
- stain removal efficacy, air polishing powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium bicarbonate powders with grain size 65 µmDrug
Also called sodium bicarbonate powders
sodium bicarbonate powders with grain size 65 µm
sodium bicarbonate powders with grain size 40 µmDrug
Also called sodium bicarbonate powders
sodium bicarbonate powders with grain size 40 µm
| Study group | Role | What they receive |
|---|---|---|
| sodium bicarbonate powders (65 µm) | Experimental | sodium bicarbonate powders with grain size 65 µm Receives: Drug: sodium bicarbonate powders with grain size 65 µm |
| sodium bicarbonate powders (40 µm) | Experimental | sodium bicarbonate powders with grain size 40 µm Receives: Drug: sodium bicarbonate powders with grain size 40 µm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time required for complete removal of extrinsic stains
Comparison of the time required for the complete removal of extrinsic stains by sodium bicarbonate powders with a grain size of 65 µm and 40 µm
Measured: 2 hr
Secondary outcomes (2)
Patient acceptance
The answers from the questionnaires about the clinical impressions of patients after treatment with sodium bicarbonate powders with a grain size of 65 µm and 40 µm
Measured: 2 hr
Operator opinion
The answers from the questionnaires about the operators' opinions after using of sodium bicarbonate powders with a grain size of 65 µm and 40 µm
Measured: 2 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study startApr 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stain Removal EfficacyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a double-blind, randomized split-mouth design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kanyawat Rattanasuwan, Study director, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140436
- Sponsor's protocol ID
- 2015/DT035
- Status last verified
- May 2017
- First submitted
- 26 Apr 2017
- Last updated
- 4 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of the Stain Removal Efficacy of Two Air Polishing Powders
- ClinicalTrials.gov ID
- NCT03140436
- Acronym / sponsor ID
- 2015/DT035
- Conditions
- Stain Removal Efficacy
- Keywords
- stain removal efficacy, air polishing powder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 4 May 2017 (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.
This study was designed to find out the stain removal efficacy and also, to find out the operators and patients opinion when use or receive treatment with both air polishing powders.
Detailed description
Using air polishing with sodium bicarbonate powders with grain size 65 µm provides efficacy in the removal of dental stains but it can cause gingival trauma if used towards the gingiva. Since having big size particles is uncomfortable, the current recommendation according to literature is to use a smaller grain size (40 µm) that results in more patient comfort. However, the efficacy of small grain size on stain removal has not been studied adequately. This study aimed to compare the stain removal efficacy between sodium bicarbonate powders with grain size 65 µm and 40 µm and also to evaluate patient's acceptance after treatment and operator's opinion after using both air polishing powders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study was designed as a double-blind, randomized split-mouth design.
| Arm | Type | Receives |
|---|---|---|
| sodium bicarbonate powders (65 µm) | Experimental | Drug: sodium bicarbonate powders with grain size 65 µmsodium bicarbonate powders with grain size 65 µm |
| sodium bicarbonate powders (40 µm) | Experimental | Drug: sodium bicarbonate powders with grain size 40 µmsodium bicarbonate powders with grain size 40 µm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy subjects who aged over 18 years old.
- Subjects who have healthy periodontal health or gingivitis.
- At least 3 upper teeth (anterior, premolar and molar) are presented on both side (right \& left side), which will be refer as index teeth, that did not present with any gingival recession, cervical abrasion and/or abfraction, caries, restoration or orthodontic appliance.
- Intrinsic stain is not present.
- Index teeth are presented with extrinsic stain with individual Lobene score scored 2 or above.
Key exclusion criteria (2 listed)
- Pregnancy or current breastfeeding mother.
- Allergy to sodium bicarbonate or the aroma of the powder
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 |
|---|---|---|
| sodium bicarbonate powders with grain size 65 µmAlso: sodium bicarbonate powderssodium bicarbonate powders with grain size 65 µm | Drug | sodium bicarbonate powders (65 µm) |
| sodium bicarbonate powders with grain size 40 µmAlso: sodium bicarbonate powderssodium bicarbonate powders with grain size 40 µm | Drug | sodium bicarbonate powders (40 µm) |
Primary outcome
The time required for complete removal of extrinsic stains
Time frame: 2 hr
Comparison of the time required for the complete removal of extrinsic stains by sodium bicarbonate powders with a grain size of 65 µm and 40 µm
2 secondary outcomes
Patient acceptance
Time frame: 2 hr
Operator opinion
Time frame: 2 hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Individual participant dataSharing planned: No
Related trials for Stain Removal Efficacy
Recruiting
Oil Pulling Whitening Mouthwash
Healthy Adult Participants, Tooth Stain
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.
Kanyawat Rattanasuwan study director
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sodium bicarbonate powders with grain size 65 µm and sodium bicarbonate powders with grain size 40 µm in people with Stain Removal Efficacy, run by Mahidol University at 1 site in Thailand.
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 5 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: finished, as of the sponsor's last update on 4 May 2017. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time required for complete removal of extrinsic stains (time frame: 2 hr). 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 4 May 2017.