Oral HygienePhase 2NCT02207400
To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms
A Phase 2 study testing Sodium bicarbonate and sodium fluoride and Sodium fluoride in people with Oral Hygiene, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study will compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be conducted at Salus Research, Inc. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene
- What is being tested?
- Sodium bicarbonate and sodium fluoride and Sodium fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2014to 30 Apr 2015
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination.
- A minimum of 20 permanent gradable teeth
- Moderate gingivitis present at the screening visit in the opinion of the investigator
- A total of 20 bleeding sites or greater at baseline visit
- Positive response to bleeding on brushing present at the screening visit
Who cannot join
- Pregnant or breast feeding women
- Tobacco chewers
- Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participant or undermines the data validity.
- Recent history (within the last year) of alcohol or other substance abuse
- Participants requiring prophylactic antibiotic treatment prior to dental therapy
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Show all 11Show fewer
- Have current active caries or any medical conditions which may directly influence gingival bleeding
- Use of concomitant or any systemic medication that, in the opinion of the investigator, might interfere with the outcome of the study or have an effect on gingival conditions within 14 days of gingival examinations
- Excessive calculus present that interferes with the probing examination for Gingival Bleeding Index
- Participation in another clinical study or receipt of an investigational drug or oral care product within 30 days of the screening visit
- An employee of the sponsor or the study site or members or their immediate family.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms
This study will compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be conducted at Salus Research, Inc. Participants will be recruited from their database and by use of an external recruitment agency
Read the detailed description
This study will be a single-centre, examiner blind, two treatment, parallel group, stratified (by baseline number of bleeding sites smoking status and bacterial sampling) randomized clinical study. At the screening visit, following provision of written informed consent, eligible participants will be provided with a standard toothpaste and toothbrush for brushing once in at the clinic and for approximately one week use at home until the baseline visit. Participants will be asked to abstain from brushing over a 12 hour period prior to the Baseline visit. At the baseline visit an oral soft tissue (OST) assessment, Modified Gingival Index (MGI) and Bleeding Index (BI), and then dental plaque assessment will be performed. Participants will be stratified according to their baseline number of bleeding sites, smoking status and whether selected for bacterial sampling. Participants will be then randomized into one of two treatment groups. After using, their assigned treatment twice daily at home for 6 weeks (visit 3), 12 weeks (visit 4) and 24 weeks (visit 5), participants will return to the site with overnight plaque at approximately the same time of day as the Baseline visit if possible. Participants will undergo a full OST examination and the recording of any Adverse Events (AEs). Participants will then undergo MGI, BI followed by dental plaque assessment. Microbiological samples will be collected on a subset of 50 participants (Determined by first 50 participants randomized).
- Conditions
- Oral Hygiene
- Being tested
- Sodium bicarbonate and sodium fluoride, Sodium fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonate and sodium fluorideDrug
Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
Sodium fluorideDrug
Comparator toothpaste containing 1100 ppm fluoride as sodium fluoride
| Study group | Role | What they receive |
|---|---|---|
| Experimental Dentifrice | Experimental | Participants were advised to brush their teeth with experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride Receives: Drug: Sodium bicarbonate and sodium fluoride |
| Reference Dentifrice | Active comparator | Participants were advised to brush their teeth with reference dentifrice containing 1100ppm fluoride as sodium fluoride Receives: Drug: Sodium fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Gingival Bleeding Sites at 24 Weeks
The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
Measured: 24 weeks
Modified Gingival Index (MGI) at 24 Weeks
MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration
Measured: 24 weeks
Secondary outcomes (5)
Number of Gingival Bleeding Sites at 6 and 12 Weeks
BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
Measured: Baseline, 6 and 12 weeks
Modified Gingival Index (MGI)) at 6 and 12 Weeks.
MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration
Measured: 6 and 12 weeks
Bleeding Index (BI) at 6, 12 and 24 Weeks
BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
Measured: 6, 12 and 24 weeks
Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.
The dental examiner had used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. Interproximal Dental Plaque Scores were analyzed in the same way as for Overall scores but just based on mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.
Measured: 6, 12 and 24 weeks
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Microbiological samples were collected at baseline, 6 weeks, 12 weeks, 24 weeks and 32 weeks. Plaque was harvested from contra-lateral 1st molar teeth, where no restorations are present, using a sterile paper point. The paper point was immersed into 4 ml of Calgon Ringer's solution in a sterile bijou and kept on ice until they can be taken to the laboratory for processing (within 24 hours).
Measured: Baseline, 6, 12, 24 and 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study start25 Aug 2014
- Primary completion1 Feb 2015
- Study completion30 Apr 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 246 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
- NCT02207400
- Sponsor's protocol ID
- 202193
- Other IDs
- RH02434
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2014
- Last updated
- 31 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jose A, Pratten J, Bosma ML, Milleman KR, Milleman JL, Wang N. Six-Month Evaluation of a Sodium Bicarbonate-Containing Toothpaste for Reduction of Established Gingivitis: A Randomized USA-Based Clinical Trial. J Clin Dent. 2018 Mar;29(1):33-39.
PubMed 29758155
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms
- ClinicalTrials.gov ID
- NCT02207400
- Acronym / sponsor ID
- 202193
- Conditions
- Oral Hygiene
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2014 (actual)
- Primary completion
- 1 Feb 2015 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Posted 26 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be conducted at Salus Research, Inc. Participants will be recruited from their database and by use of an external recruitment agency
Detailed description
This study will be a single-centre, examiner blind, two treatment, parallel group, stratified (by baseline number of bleeding sites smoking status and bacterial sampling) randomized clinical study. At the screening visit, following provision of written informed consent, eligible participants will be provided with a standard toothpaste and toothbrush for brushing once in at the clinic and for approximately one week use at home until the baseline visit. Participants will be asked to abstain from brushing over a 12 hour period prior to the Baseline visit. At the baseline visit an oral soft tissue (OST) assessment, Modified Gingival Index (MGI) and Bleeding Index (BI), and then dental plaque assessment will be performed. Participants will be stratified according to their baseline number of bleeding sites, smoking status and whether selected for bacterial sampling. Participants will be then randomized into one of two treatment groups. After using, their assigned treatment twice daily at home for 6 weeks (visit 3), 12 weeks (visit 4) and 24 weeks (visit 5), participants will return to the site with overnight plaque at approximately the same time of day as the Baseline visit if possible. Participants will undergo a full OST examination and the recording of any Adverse Events (AEs). Participants will then undergo MGI, BI followed by dental plaque assessment. Microbiological samples will be collected on a subset of 50 participants (Determined by first 50 participants randomized).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Dentifrice | Experimental | Drug: Sodium bicarbonate and sodium fluorideParticipants were advised to brush their teeth with experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride |
| Reference Dentifrice | Active comparator | Drug: Sodium fluorideParticipants were advised to brush their teeth with reference dentifrice containing 1100ppm fluoride as sodium fluoride |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination.
- A minimum of 20 permanent gradable teeth
- Moderate gingivitis present at the screening visit in the opinion of the investigator
- A total of 20 bleeding sites or greater at baseline visit
- Positive response to bleeding on brushing present at the screening visit
Key exclusion criteria (11 listed)
- Pregnant or breast feeding women
- Tobacco chewers
- Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participant or undermines the data validity.
- Recent history (within the last year) of alcohol or other substance abuse
- Participants requiring prophylactic antibiotic treatment prior to dental therapy
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 and sodium fluorideExperimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride | Drug | Experimental Dentifrice |
| Sodium fluorideComparator toothpaste containing 1100 ppm fluoride as sodium fluoride | Drug | Reference Dentifrice |
Primary outcome
Number of Gingival Bleeding Sites at 24 Weeks
Time frame: 24 weeks
The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
Modified Gingival Index (MGI) at 24 Weeks
Time frame: 24 weeks
MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration
5 secondary outcomes
Number of Gingival Bleeding Sites at 6 and 12 Weeks
Time frame: Baseline, 6 and 12 weeks
Modified Gingival Index (MGI)) at 6 and 12 Weeks.
Time frame: 6 and 12 weeks
Bleeding Index (BI) at 6, 12 and 24 Weeks
Time frame: 6, 12 and 24 weeks
Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.
Time frame: 6, 12 and 24 weeks
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Time frame: Baseline, 6, 12, 24 and 32 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29758155Jose A, Pratten J, Bosma ML, Milleman KR, Milleman JL, Wang N. Six-Month Evaluation of a Sodium Bicarbonate-Containing Toothpaste for Reduction of Established Gingivitis: A Randomized USA-Based Clinical Trial. J Clin Dent. 2018 Mar;29(1):33-39.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium bicarbonate and sodium fluoride and Sodium fluoride in people with Oral Hygiene, run by GlaxoSmithKline at 1 site in United States.
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 11 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 31 Jul 2018. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Jul 2016). 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?
Number of Gingival Bleeding Sites at 24 Weeks (time frame: 24 weeks). 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?
On the ClinicalTrials.gov record for NCT02207400, 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 31 Jul 2018.