Trial · NCT02207907
To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste
NCT02207907, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-02-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste. Trials, record NCT02207907. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02207907
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste
- NCT number
- NCT02207907
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 247 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Oral Hygiene
- Interventions
- Sodium bicarbonate plus sodium fluoride, Sodium fluoride
- First posted
- 2014-08-04
- Last updated
- 2017-04-13
- Results first posted
- 2017-02-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Gingival Bleeding Sites at 24 Weeks | 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. |
| Primary | Modified Gingival Index (MGI) at 24 Weeks | 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 |
| Secondary | Number of Gingival Bleeding Sites at 6 and 12 Weeks. | Baseline, 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. |
| Secondary | Modified Gingival Index (MGI) at 6 and 12 Weeks. | Baseline, 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 |
| Secondary | Bleeding Index at 6, 12 and 24 Weeks | Baseline, 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 |
| Secondary | Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks. | Baseline, 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 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Gingival Bleeding Sites at 24 Weeks | Baseline, 24 weeks | Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement. | number of gingival bleeding sites | MEAN |
| PRIMARY | Modified Gingival Index (MGI) at 24 Weeks | Baseline, 24 weeks | Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Units on a scale | MEAN |
| SECONDARY | Number of Gingival Bleeding Sites at 6 and 12 Weeks. | Baseline, 6 and 12 weeks | Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | number of gingival bleeding sites | MEAN |
| SECONDARY | Modified Gingival Index (MGI) at 6 and 12 Weeks. | Baseline, 6 and 12 weeks | Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Units on a scale | MEAN |
| SECONDARY | Bleeding Index at 6, 12 and 24 Weeks | Baseline, 6, 12 and 24 weeks | Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Units on a Scale | MEAN |
| SECONDARY | Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks. | Baseline, 6,12 and 24 weeks | Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Gingival Bleeding Sites at 24 Weeks | Sodium Bicarbonate Dentrifice | Number of Bleeding Sites at Baseline | 45.13 | Standard Error 1.393 | number of gingival bleeding sites |
| Number of Gingival Bleeding Sites at 24 Weeks | 0% Sodium Bicarbonate Dentrifice | Number of Bleeding Sites at Baseline | 45.84 | Standard Error 1.448 | number of gingival bleeding sites |
| Number of Gingival Bleeding Sites at 24 Weeks | Sodium Bicarbonate Dentrifice | Number of Bleeding sites after 24 weeks | 18.67 | Standard Error 1.142 | number of gingival bleeding sites |
| Number of Gingival Bleeding Sites at 24 Weeks | 0% Sodium Bicarbonate Dentrifice | Number of Bleeding sites after 24 weeks | 36.39 | Standard Error 1.510 | number of gingival bleeding sites |
| Modified Gingival Index (MGI) at 24 Weeks | Sodium Bicarbonate Dentrifice | Modified Gingival Index at Baseline | 2.53 | Standard Error 0.017 | Units on a scale |
| Modified Gingival Index (MGI) at 24 Weeks | 0% Sodium Bicarbonate Dentrifice | Modified Gingival Index at Baseline | 2.54 | Standard Error 0.018 | Units on a scale |
| Modified Gingival Index (MGI) at 24 Weeks | Sodium Bicarbonate Dentrifice | Modified Gingival Index after 24 weeks | 2.23 | Standard Error 0.021 | Units on a scale |
| Modified Gingival Index (MGI) at 24 Weeks | 0% Sodium Bicarbonate Dentrifice | Modified Gingival Index after 24 weeks | 2.43 | Standard Error 0.210 | Units on a scale |
| Number of Gingival Bleeding Sites at 6 and 12 Weeks. | Sodium Bicarbonate Dentrifice | Number of Bleeding Sites at Baseline | 45.13 | Standard Error 1.393 | number of gingival bleeding sites |
| Number of Gingival Bleeding Sites at 6 and 12 Weeks. | 0% Sodium Bicarbonate | Number of Bleeding Sites at Baseline | 45.84 | Standard Error 1.448 | number of gingival bleeding sites |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sodium Bicarbonate Dentrifice | 124 | |
| Overall Study | STARTED | 0% Sodium Bicarbonate Dentrifice | 123 | |
| Overall Study | COMPLETED | Sodium Bicarbonate Dentrifice | 113 | |
| Overall Study | COMPLETED | 0% Sodium Bicarbonate Dentrifice | 115 | |
| Overall Study | NOT COMPLETED | Sodium Bicarbonate Dentrifice | 11 | |
| Overall Study | NOT COMPLETED | 0% Sodium Bicarbonate Dentrifice | 8 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | MOUTH INJURY | Injury, poisoning and procedural complications | Sodium Bicarbonate Dentrifice | 3 | 124 | |
| other | MOUTH INJURY | Injury, poisoning and procedural complications | 0% Sodium Bicarbonate Dentrifice | 3 | 123 | |
| other | PROCEDURAL PAIN | Injury, poisoning and procedural complications | Sodium Bicarbonate Dentrifice | 1 | 124 | |
| other | PROCEDURAL PAIN | Injury, poisoning and procedural complications | 0% Sodium Bicarbonate Dentrifice | 1 | 123 | |
| other | THERMAL BURN | Injury, poisoning and procedural complications | Sodium Bicarbonate Dentrifice | 1 | 124 | |
| other | THERMAL BURN | Injury, poisoning and procedural complications | 0% Sodium Bicarbonate Dentrifice | 1 | 123 | |
| other | BRONCHITIS | Infections and infestations | Sodium Bicarbonate Dentrifice | 1 | 124 | |
| other | BRONCHITIS | Infections and infestations | 0% Sodium Bicarbonate Dentrifice | 0 | 123 | |
| other | NASOPHARYNGITIS | Infections and infestations | Sodium Bicarbonate Dentrifice | 0 | 124 | |
| other | NASOPHARYNGITIS | Infections and infestations | 0% Sodium Bicarbonate Dentrifice | 1 | 123 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sodium Bicarbonate Dentrifice | ||
| Total, all-cause mortality | 0% Sodium Bicarbonate Dentrifice | ||
| Total, other adverse events | Sodium Bicarbonate Dentrifice | 7 | 124 |
| Total, other adverse events | 0% Sodium Bicarbonate Dentrifice | 8 | 123 |
| Total, serious adverse events | Sodium Bicarbonate Dentrifice | 0 | 124 |
| Total, serious adverse events | 0% Sodium Bicarbonate Dentrifice | 0 | 123 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sodium Bicarbonate Dentrifice vs 0% Sodium Bicarbonate Dentrifice: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02207907
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