Trial · NCT02207400
To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms
NCT02207400, Phase 2, Completed, GlaxoSmithKline; results first posted 2016-07-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms. Trials, record NCT02207400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02207400
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms
- NCT number
- NCT02207400
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 246 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Oral Hygiene
- Interventions
- Sodium bicarbonate and sodium fluoride, Sodium fluoride
- First posted
- 2014-08-04
- Last updated
- 2018-07-31
- Results first posted
- 2016-07-26
Source ClinicalTrials.gov
Registered outcomes7
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 | 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 |
| Primary | Modified Gingival Index (MGI) at 24 Weeks | 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 |
| Secondary | Number of Gingival Bleeding Sites at 6 and 12 Weeks | Baseline, 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 |
| Secondary | Modified Gingival Index (MGI)) at 6 and 12 Weeks. | 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 (BI) at 6, 12 and 24 Weeks | 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 |
| Secondary | Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks. | 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. |
| Secondary | Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks | Baseline, 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). |
Source ClinicalTrials.gov
Outcomes7
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 | 24 weeks | ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement. | Number of bleeding sites | MEAN |
| PRIMARY | Modified Gingival Index (MGI) at 24 Weeks | 24 weeks | ITT population defined as those participants who had 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 | ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement. | Number of bleeding sites | MEAN |
| SECONDARY | Modified Gingival Index (MGI)) at 6 and 12 Weeks. | 6 and 12 weeks | ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement. | Units on a scale | MEAN |
| SECONDARY | Bleeding Index (BI) at 6, 12 and 24 Weeks | 6, 12 and 24 weeks | ITT population defined as those participants who had 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) at 6, 12 and 24 Weeks. | 6, 12 and 24 weeks | ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement. | Units on a scale | MEAN |
| SECONDARY | Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks | Baseline, 6, 12, 24 and 32 weeks | ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement. | colony forming units per sample | MEAN |
Source ClinicalTrials.gov
Results by group72
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 and Sodium Fluoride Dentifrice | 13.24 | Standard Deviation 7.663 | Number of bleeding sites | |
| Number of Gingival Bleeding Sites at 24 Weeks | Sodium Fluoride Dentifrice | 24.90 | Standard Deviation 9.044 | Number of bleeding sites | |
| Modified Gingival Index (MGI) at 24 Weeks | Sodium Bicarbonate and Sodium Fluoride Dentifrice | 1.26 | Standard Deviation 0.505 | Units on a scale | |
| Modified Gingival Index (MGI) at 24 Weeks | Sodium Fluoride Dentifrice | 1.93 | Standard Deviation 0.408 | Units on a scale | |
| Number of Gingival Bleeding Sites at 6 and 12 Weeks | Sodium Bicarbonate and Sodium Fluoride Dentifrice | Number of Bleeding Sites at Baseline | 29.76 | Standard Deviation 8.238 | Number of bleeding sites |
| Number of Gingival Bleeding Sites at 6 and 12 Weeks | Sodium Fluoride Dentifrice | Number of Bleeding Sites at Baseline | 29.05 | Standard Deviation 8.390 | Number of bleeding sites |
| Number of Gingival Bleeding Sites at 6 and 12 Weeks | Sodium Bicarbonate and Sodium Fluoride Dentifrice | Number of Bleeding Sites at 6 weeks | 12.26 | Standard Deviation 9.339 | Number of bleeding sites |
| Number of Gingival Bleeding Sites at 6 and 12 Weeks | Sodium Fluoride Dentifrice | Number of Bleeding Sites at 6 weeks | 23.23 | Standard Deviation 10.993 | Number of bleeding sites |
| Number of Gingival Bleeding Sites at 6 and 12 Weeks | Sodium Bicarbonate and Sodium Fluoride Dentifrice | Number of Bleeding Sites at 12 weeks | 15.73 | Standard Deviation 7.632 | Number of bleeding sites |
| Number of Gingival Bleeding Sites at 6 and 12 Weeks | Sodium Fluoride Dentifrice | Number of Bleeding Sites at 12 weeks | 23.86 | Standard Deviation 9.265 | Number of bleeding sites |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 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 and Sodium Fluoride Dentifrice | 123 | |
| Overall Study | STARTED | Sodium Fluoride Dentifrice | 123 | |
| Overall Study | COMPLETED | Sodium Bicarbonate and Sodium Fluoride Dentifrice | 107 | |
| Overall Study | COMPLETED | Sodium Fluoride Dentifrice | 109 | |
| Overall Study | NOT COMPLETED | Sodium Bicarbonate and Sodium Fluoride Dentifrice | 16 | |
| Overall Study | NOT COMPLETED | Sodium Fluoride Dentifrice | 14 |
Source ClinicalTrials.gov
Adverse events54
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 | Cellulitis Orbital | Infections and infestations | Sodium Bicarbonate and Sodium Fluoride Dentifrice | 2 | 123 | 2 |
| other | Cellulitis Orbital | Infections and infestations | Sodium Fluoride Dentifrice | 0 | 123 | 0 |
| other | Lower Respiratory Tract Infection | Infections and infestations | Sodium Bicarbonate and Sodium Fluoride Dentifrice | 1 | 123 | 2 |
| other | Lower Respiratory Tract Infection | Infections and infestations | Sodium Fluoride Dentifrice | 0 | 123 | 0 |
| other | Pneumonia | Infections and infestations | Sodium Bicarbonate and Sodium Fluoride Dentifrice | 2 | 123 | 2 |
| other | Pneumonia | Infections and infestations | Sodium Fluoride Dentifrice | 0 | 123 | 0 |
| other | Acute sinusitis | Infections and infestations | Sodium Bicarbonate and Sodium Fluoride Dentifrice | 0 | 123 | 0 |
| other | Acute sinusitis | Infections and infestations | Sodium Fluoride Dentifrice | 1 | 123 | 1 |
| other | GASTROENTERITIS | Infections and infestations | Sodium Bicarbonate and Sodium Fluoride Dentifrice | 1 | 123 | 1 |
| other | GASTROENTERITIS | Infections and infestations | Sodium Fluoride Dentifrice | 0 | 123 | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sodium Bicarbonate and Sodium Fluoride Dentifrice | ||
| Total, all-cause mortality | Sodium Fluoride Dentifrice | ||
| Total, other adverse events | Sodium Bicarbonate and Sodium Fluoride Dentifrice | 17 | 123 |
| Total, other adverse events | Sodium Fluoride Dentifrice | 14 | 123 |
| Total, serious adverse events | Sodium Bicarbonate and Sodium Fluoride Dentifrice | 0 | 123 |
| Total, serious adverse events | Sodium Fluoride Dentifrice | 0 | 123 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29758155 | DERIVED |
Source PubMed
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 and Sodium Fluoride Dentifrice vs Sodium Fluoride Dentifrice: 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/NCT02207400
GET https://conductscience.org/api/trials/v1/NCT02207400/results?page=2