Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RH02434 | Other Identifier | GSK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Reference Dentifrice | Active Comparator | Participants were advised to brush their teeth with reference dentifrice containing 1100ppm fluoride as sodium fluoride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate and sodium fluoride | Drug | Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fort Wayne | Indiana | 46825 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29758155 | Derived | 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. |
Not provided
Not provided
Not provided
The participants were recruited at a clinical site in the USA.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Bicarbonate and Sodium Fluoride Dentifrice | Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride |
| FG001 | Sodium Fluoride Dentifrice | Toothpaste containing 1100 ppm fluoride as sodium fluoride |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Bicarbonate and Sodium Fluoride Dentifrice | Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride |
| BG001 | Sodium Fluoride Dentifrice |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Number of bleeding sites | 24 weeks |
|
Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sodium Bicarbonate and Sodium Fluoride Dentifrice | Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis Orbital | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D012969 | Sodium Fluoride |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sodium fluoride | Drug | Comparator toothpaste containing 1100 ppm fluoride as sodium fluoride |
|
| 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 | 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 | 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. | 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). | Baseline, 6, 12, 24 and 32 weeks |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Positive Urine Pregnancy Test |
|
Toothpaste containing 1100 ppm fluoride as sodium fluoride
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Sodium Fluoride Dentifrice | Toothpaste containing 1100 ppm fluoride as sodium fluoride |
|
|
|
| Primary | 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 | ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Units on a scale | 24 weeks |
|
|
|
|
| Secondary | 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 | ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Number of bleeding sites | Baseline, 6 and 12 weeks |
|
|
|
| Secondary | 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 | ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Units on a scale | 6 and 12 weeks |
|
|
|
| Secondary | 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 | ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Units on a Scale | 6, 12 and 24 weeks |
|
|
|
| Secondary | 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. | ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Units on a scale | 6, 12 and 24 weeks |
|
|
|
| Secondary | 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). | ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | colony forming units per sample | Baseline, 6, 12, 24 and 32 weeks |
|
|
|
| 0 |
| 123 |
| 17 |
| 123 |
| EG001 | Sodium Fluoride Dentifrice | Toothpaste containing 1100 ppm fluoride as sodium fluoride | 0 | 123 | 14 | 123 |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| PULPITIS DENTAL | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| TOOTH ABSCESS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| MOUTH INJURY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| TRAUMATIC ULCER | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| CHEILITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| SENSITIVITY OF TEETH | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| APHTHOUS STOMATITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| GINGIVAL ULCERATION | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| TONGUE ULCERATION | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYPOTHYROIDISM | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
|
| BURNING SENSATION | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| PULMONARY CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| INGROWING NAIL | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| Number of Bleeding Sites at 12 weeks |
|
| BI Score Score at 24 weeks |
|
| Overall Plaque Score at 24 weeks |
|
| Interproximal Plaque Score at 6 weeks |
|
| Interproximal Plaque Score at 12 weeks |
|
| Interproximal Plaque Score at 24 weeks |
|
| Steph Count at 12 weeks (n=24, 26) |
|
| Steph Count at 24 weeks (n=23, 25) |
|
| Steph Count at 32 weeks (n=21, 21) |
|
| Yeast Count at Baseline (n=24, 26) |
|
| Yeast Count at 6 weeks (n=23, 26) |
|
| Yeast Count at 12 weeks (n=24, 25) |
|
| Yeast Count at 24 weeks (n=17, 22) |
|
| Yeast Count at 32 weeks (n= 14, 14) |
|
| Coliform count at Baseline (n= 24, 26) |
|
| Coliform count at 6 weeks (n= 24, 26) |
|
| Coliform count at 12 weeks (n= 24, 26) |
|
| Coliform count at 24 weeks (n=23, 25) |
|
| Coliform count at 32 weeks (n=21, 21) |
|
| E. Coli count at Baseline (n=24, 26) |
|
| E. Coli count at 6 weeks (n=24, 26) |
|
| E. Coli count at 12 weeks (n=24, 26) |
|
| E. Coli count at 24 weeks (n=23, 25) |
|
| E. Coli count at 32 weeks (n=21, 21) |
|