Oral HygienePhase 2NCT02207907

To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste

A Phase 2 study testing Sodium bicarbonate plus sodium fluoride and Sodium fluoride in people with Oral Hygiene, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objectives of this study will be to 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 Silverstone Research Group. 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 plus sodium fluoride and Sodium fluoride
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 247 participants
Where: 1 siteUnited States
Study dates: Aug 2014to Mar 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 participants 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.

United States1 site

GSK Investigational Site
Las Vegas, Nevada, 89146

Other trials in United States

About this study

Official title: A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste

Conditions: Oral Hygiene
Being tested: Sodium bicarbonate plus 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 plus sodium fluorideDrug
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
Sodium fluorideDrug
Toothpaste containing 1100 ppm fluoride as sodium fluoride

Study groups in NCT02207907
Study group	Role	What they receive
Sodium bicarbonate plus sodium fluoride	Experimental	Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride Receives: Drug: Sodium bicarbonate plus sodium fluoride
Sodium fluoride	Active comparator	Toothpaste containing 1100 ppm 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
Number of gingival bleeding sites were measured as bleeding index via 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 to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.
Measured: Baseline, 24 weeks
Modified Gingival Index (MGI) at 24 Weeks
The Modified Gingival Index (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: Baseline, 24 weeks

Secondary outcomes (4)

Number of Gingival Bleeding Sites at 6 and 12 Weeks.
Number of gingival bleeding sites were measured as bleeding index via 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 to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.
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: Baseline, 6 and 12 weeks
Bleeding Index at 6, 12 and 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 to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
Measured: Baseline, 6, 12 and 24 weeks
Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.
The dental examiner used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. They had expectorated and rinsed with 10 mL of water for 10 seconds and expectorated again. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 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 tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth
Measured: Baseline, 6,12 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Mar 2015

First posted4 Aug 2014 (estimated)
Study startAug 2014
Primary completionFeb 2015
Study completionMar 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.
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: 247 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02207907
Sponsor's protocol ID: 202192
Other IDs: RH02433
Status last verified: Dec 2016
First submitted: 31 Jul 2014
Last updated: 13 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Not yet recruiting
Game-based Oral Health Promotion
Oral Hygiene
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis

All Oral Hygiene trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2017. 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
ClinicalTrials.gov ID: NCT02207907
Acronym / sponsor ID: 202192
Conditions: Oral Hygiene
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 247 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Feb 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 4 Aug 2014 (estimated)
Results: Posted 17 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Sodium bicarbonate plus sodium fluoride	Experimental	Drug: Sodium bicarbonate plus sodium fluorideExperimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
Sodium fluoride	Active comparator	Drug: Sodium fluorideToothpaste containing 1100 ppm 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 participants 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 plus sodium fluorideExperimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride	Drug	Sodium bicarbonate plus sodium fluoride
Sodium fluorideToothpaste containing 1100 ppm fluoride as sodium fluoride	Drug	Sodium fluoride

Primary outcome

Number of Gingival Bleeding Sites at 24 Weeks
Time frame: Baseline, 24 weeks
Number of gingival bleeding sites were measured as bleeding index via 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 to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.
Modified Gingival Index (MGI) at 24 Weeks
Time frame: Baseline, 24 weeks
The Modified Gingival Index (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

4 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: Baseline, 6 and 12 weeks
Bleeding Index at 6, 12 and 24 Weeks
Time frame: Baseline, 6, 12 and 24 weeks
Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.
Time frame: Baseline, 6,12 and 24 weeks

Results and safety

Results posted to the registry on 17 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sodium Bicarbonate Dentrifice	124	113
0% Sodium Bicarbonate Dentrifice	123	115

Primary outcome: Number of Gingival Bleeding Sites at 24 Weeks

Time frame: Baseline, 24 weeks. Mean (Standard Error). Unit: number of gingival bleeding sites

Measure	Sodium Bicarbonate Dentrifice n = 118	0% Sodium Bicarbonate Dentrifice n = 122
Number of Bleeding Sites at Baseline	45.13 (1.393)	45.84 (1.448)
Number of Bleeding sites after 24 weeks	18.67 (1.142)	36.39 (1.510)

Sodium Bicarbonate Dentrifice vs 0% Sodium Bicarbonate Dentrifice: Adjusted Mean Difference: -17.491 (95% CI -20.317 to -14.664), p <0.0001, ANCOVA

Population analysed: Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement.

Primary outcome: Modified Gingival Index (MGI) at 24 Weeks

Time frame: Baseline, 24 weeks. Mean (Standard Error). Unit: Units on a scale

Measure	Sodium Bicarbonate Dentrifice n = 118	0% Sodium Bicarbonate Dentrifice n = 122
Modified Gingival Index at Baseline	2.53 (0.017)	2.54 (0.018)
Modified Gingival Index after 24 weeks	2.23 (0.021)	2.43 (0.210)

Sodium Bicarbonate Dentrifice vs 0% Sodium Bicarbonate Dentrifice: Adjusted Mean Difference: -0.201 (95% CI -0.237 to -0.165), p <0.0001, ANCOVA

Population analysed: Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sodium Bicarbonate Dentrifice	0 of 124 (0%)	7 of 124 (5.6%)	Not reported
0% Sodium Bicarbonate Dentrifice	0 of 123 (0%)	8 of 123 (6.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Oral Hygiene

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Not yet recruiting
Game-based Oral Health Promotion
Oral Hygiene
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
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Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
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Not yet recruiting
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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 plus 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 13 Apr 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 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 17 Feb 2017). 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: Baseline, 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 NCT02207907.

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 13 Apr 2017.