Oral HygienePhase 4NCT01962493
An Efficacy Study of Stain Control of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Tooth Staining
A Phase 4 study testing Sodium bicarbonate/ Sodium Fluoride, Sodium fluoride and Chlorhexidine digluconate in people with Oral Hygiene, run by GlaxoSmithKline at 3 sites in United Kingdom.
Trial summary
The aim of this study is to compare the stain effect on teeth of twice daily brushing with a 67% sodium bicarbonate containing toothpaste versus standard toothpaste (not containing sodium bicarbonate) for six weeks whilst using a chlorhexidine digluconate 0.2% mouthwash. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene
- What is being tested?
- Sodium bicarbonate/ Sodium Fluoride, Sodium fluoride and Chlorhexidine digluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Sep 2013to Nov 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good oral health in the opinion of the investigator (excluding gingivitis)
- A minimum of 11 of the 12 permanent gradable anterior teeth at screening
- Stain levels on the buccal surfaces of the 6 maxillary and 6 mandibular anterior teeth need to be at least "mild" and present on a minimum of 4 teeth
- Modification of the Lobene Stain Index - At Visit 2, a baseline total MLSI Intensity x Area score (four sites per tooth) of greater than or equal to 8 for facial surfaces of anterior teeth.
Who cannot join
- Pregnant women or women who are intending to become pregnant over the duration of the study
- Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds).
- Current use of Chlorhexidine, Cetylpyridinium Chloride or any marketed mouthwash
- Past or current use of any drug which is known to be associated with tooth discolouration within 30 days of screening or during the study period.
- Recent history (within the last 1 year) of alcohol or other substance abuse
- Dental conditions / disease requiring immediate treatment; Crowns or veneers on more than one anterior tooth; pre-existing sensitivity to oral care products; severe periodontitis; severe recession; dental implants; active carious lesions on anterior teeth; oral lesions/manifestations; prone to aphthous stomatitis and ulceration etc.
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- Participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study.
- Medical condition which would require the use of prophylactic antibiotics prior to dental cleanings
- Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study or any condition that presents undue risk from the study treatment or procedures in the opinion of the investigator or dental assessor.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Intertek - Maldon (formerly 4 Front Research Ltd)
Maldon, Essex, CM9 5PN
Intertek - Manchester Science Park
Manchester, M15 6SE
Intertek 4-Front Research - Widnes
Widnes, Cheshire, WA8 6PG
About this study
Official title: A Study to Evaluate the Effect of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Digluconate Tooth Staining
The aim of this study is to compare the stain effect on teeth of twice daily brushing with a 67% sodium bicarbonate containing toothpaste versus standard toothpaste (not containing sodium bicarbonate) for six weeks whilst using a chlorhexidine digluconate 0.2% mouthwash.
- Conditions
- Oral Hygiene
- Being tested
- Sodium bicarbonate/ Sodium Fluoride, Sodium fluoride, Chlorhexidine digluconate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonate/ Sodium FluorideOther
Toothpaste containing sodium bicarbonate and sodium fluoride as cosmetic
Sodium fluorideOther
Toothpaste containing sodium fluoride as cosmetic
Chlorhexidine digluconateDrug
Mouthwash containing chlorhexidine digluconate
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate/ Sodium Fluoride toothpaste | Other | Marketed Sodium bicarbonate toothpaste containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF) Receives: Other: Sodium bicarbonate/ Sodium Fluoride |
| Sodium fluoride toothpaste | Active comparator | Non-sodium bicarbonate toothpaste containing 1450ppm fluoride as NaF Receives: Other: Sodium fluoride |
| Chlorhexidine digluconate mouthwash | Other | 0.2% w/v Chlorhexidine digluconate mouthwash for rinsing post-brushing with study toothpastes Receives: Drug: Chlorhexidine digluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Lobene Stain Index (MLSI) at Week 6
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Measured: Week 6 post treatment administration
Secondary outcomes (7)
Overall MLSI at Week 3
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Measured: Week 3 post treatment administration
Overall Facial MLSI at Week 3
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Measured: Week 3 post treatment administration
Overall Facial MLSI at Week 6
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Measured: Week 6 post treatment administration
Overall Interproximal MLSI at Week 3
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Measured: Week 3 post treatment administration
Overall Interproximal MLSI at Week 6
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Measured: Week 6 post treatment administration
Overall Gingival and Interproximal MLSI at Week 3
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Measured: Week 3 post treatment administration
Overall Gingival and Interproximal MLSI at Week 6
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Measured: Week 6 post treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962493
- Sponsor's protocol ID
- 202182
- Other IDs
- RH01913
- Status last verified
- Feb 2015
- First submitted
- 10 Oct 2013
- Last updated
- 3 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Akwagyiram I, Butler A, Maclure R, Colgan P, Yan N, Bosma ML. A randomised clinical trial to evaluate the effect of a 67 % sodium bicarbonate-containing dentifrice on 0.2 % chlorhexidine digluconate mouthwash tooth staining. BMC Oral Health. 2016 Aug 25;16(1):79. doi: 10.1186/s12903-016-0271-3.
PubMed 27557865
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Digluconate Tooth Staining
- ClinicalTrials.gov ID
- NCT01962493
- Acronym / sponsor ID
- 202182
- Conditions
- Oral Hygiene
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Posted 3 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the stain effect on teeth of twice daily brushing with a 67% sodium bicarbonate containing toothpaste versus standard toothpaste (not containing sodium bicarbonate) for six weeks whilst using a chlorhexidine digluconate 0.2% mouthwash.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate/ Sodium Fluoride toothpaste | Other | Other: Sodium bicarbonate/ Sodium FluorideMarketed Sodium bicarbonate toothpaste containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF) |
| Sodium fluoride toothpaste | Active comparator | Other: Sodium fluorideNon-sodium bicarbonate toothpaste containing 1450ppm fluoride as NaF |
| Chlorhexidine digluconate mouthwash | Other | Drug: Chlorhexidine digluconate0.2% w/v Chlorhexidine digluconate mouthwash for rinsing post-brushing with study toothpastes |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Good oral health in the opinion of the investigator (excluding gingivitis)
- A minimum of 11 of the 12 permanent gradable anterior teeth at screening
- Stain levels on the buccal surfaces of the 6 maxillary and 6 mandibular anterior teeth need to be at least "mild" and present on a minimum of 4 teeth
- Modification of the Lobene Stain Index - At Visit 2, a baseline total MLSI Intensity x Area score (four sites per tooth) of greater than or equal to 8 for facial surfaces of anterior teeth.
Key exclusion criteria (9 listed)
- Pregnant women or women who are intending to become pregnant over the duration of the study
- Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds).
- Current use of Chlorhexidine, Cetylpyridinium Chloride or any marketed mouthwash
- Past or current use of any drug which is known to be associated with tooth discolouration within 30 days of screening or during the study period.
- Recent history (within the last 1 year) of alcohol or other substance abuse
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/ Sodium FluorideToothpaste containing sodium bicarbonate and sodium fluoride as cosmetic | Other | Sodium bicarbonate/ Sodium Fluoride toothpaste |
| Sodium fluorideToothpaste containing sodium fluoride as cosmetic | Other | Sodium fluoride toothpaste |
| Chlorhexidine digluconateMouthwash containing chlorhexidine digluconate | Drug | Chlorhexidine digluconate mouthwash |
Primary outcome
Modified Lobene Stain Index (MLSI) at Week 6
Time frame: Week 6 post treatment administration
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
7 secondary outcomes
Overall MLSI at Week 3
Time frame: Week 3 post treatment administration
Overall Facial MLSI at Week 3
Time frame: Week 3 post treatment administration
Overall Facial MLSI at Week 6
Time frame: Week 6 post treatment administration
Overall Interproximal MLSI at Week 3
Time frame: Week 3 post treatment administration
Overall Interproximal MLSI at Week 6
Time frame: Week 6 post treatment administration
Overall Gingival and Interproximal MLSI at Week 3
Time frame: Week 3 post treatment administration
Overall Gingival and Interproximal MLSI at Week 6
Time frame: Week 6 post treatment administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27557865Akwagyiram I, Butler A, Maclure R, Colgan P, Yan N, Bosma ML. A randomised clinical trial to evaluate the effect of a 67 % sodium bicarbonate-containing dentifrice on 0.2 % chlorhexidine digluconate mouthwash tooth staining. BMC Oral Health. 2016 Aug 25;16(1):79. doi: 10.1186/s12903-016-0271-3.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium bicarbonate/ Sodium Fluoride, Sodium fluoride and Chlorhexidine digluconate in people with Oral Hygiene, run by GlaxoSmithKline at 3 sites in United Kingdom.
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 4 inclusion and 9 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 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Modified Lobene Stain Index (MLSI) at Week 6 (time frame: Week 6 post treatment administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01962493, which also lists 1 linked publication.
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 Mar 2015.