Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RH01913 | 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
The aim of this study is to compare the stain effect on teeth of twice daily brushing with a 67% sodium bicarbonate containing toothpaste versus standard toothpaste (not containing sodium bicarbonate) for six weeks whilst using a chlorhexidine digluconate 0.2% mouthwash.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium bicarbonate/ Sodium Fluoride toothpaste | Other | Marketed Sodium bicarbonate toothpaste containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF) |
|
| Sodium fluoride toothpaste | Active Comparator | Non-sodium bicarbonate toothpaste containing 1450ppm fluoride as NaF |
|
| Chlorhexidine digluconate mouthwash | Other | 0.2% w/v Chlorhexidine digluconate mouthwash for rinsing post-brushing with study toothpastes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate/ Sodium Fluoride | Other | Toothpaste containing sodium bicarbonate and sodium fluoride as cosmetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Lobene Stain Index (MLSI) at Week 6 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). | Week 6 post treatment administration |
| Measure | Description | Time Frame |
|---|---|---|
| Overall MLSI at Week 3 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). |
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 |
|---|---|---|---|---|---|---|
| Intertek 4-Front Research - Widnes | Widnes | Cheshire | WA8 6PG | United Kingdom | ||
| Intertek - Maldon (formerly 4 Front Research Ltd) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27557865 | Derived | Akwagyiram I, Butler A, Maclure R, Colgan P, Yan N, Bosma ML. A randomised clinical trial to evaluate the effect of a 67 % sodium bicarbonate-containing dentifrice on 0.2 % chlorhexidine digluconate mouthwash tooth staining. BMC Oral Health. 2016 Aug 25;16(1):79. doi: 10.1186/s12903-016-0271-3. |
Not provided
Not provided
In total 314 participants were screened and 160 participants were randomised of whom 150 completed the study. Of the 10 participants that did not completed the study, 3 had adverse events; 1 had protocol violation and 6 had withdrawal of consent.
The study was conducted at two sites in the UK. Participants were recruited from the site's database and by use of advertisements.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sodium fluoride | Other | Toothpaste containing sodium fluoride as cosmetic |
|
| Chlorhexidine digluconate | Drug | Mouthwash containing chlorhexidine digluconate |
|
| Week 3 post treatment administration |
| Overall Facial MLSI at Week 3 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). | Week 3 post treatment administration |
| Overall Facial MLSI at Week 6 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). | Week 6 post treatment administration |
| Overall Interproximal MLSI at Week 3 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). | Week 3 post treatment administration |
| Overall Interproximal MLSI at Week 6 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). | Week 6 post treatment administration |
| Overall Gingival and Interproximal MLSI at Week 3 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). | Week 3 post treatment administration |
| Overall Gingival and Interproximal MLSI at Week 6 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). | Week 6 post treatment administration |
| Maldon |
| Essex |
| CM9 5PN |
| United Kingdom |
| Intertek - Manchester Science Park | Manchester | M15 6SE | United Kingdom |
| FG001 | NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner. |
| BG001 | NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Modified Lobene Stain Index (MLSI) at Week 6 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). | The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments. | Posted | Mean | Standard Deviation | Score on a Scale | Week 6 post treatment administration |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall MLSI at Week 3 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). | The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments. | Posted | Mean | Standard Deviation | Score on a Scale | Week 3 post treatment administration |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Facial MLSI at Week 3 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). | The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments. | Posted | Mean | Standard Deviation | Score on a Scale | Week 3 post treatment administration |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Facial MLSI at Week 6 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). | The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments. | Posted | Mean | Standard Deviation | Score on a Scale | Week 6 post treatment administration |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Interproximal MLSI at Week 3 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). | The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments. | Posted | Mean | Standard Deviation | Score on a Scale | Week 3 post treatment administration |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Interproximal MLSI at Week 6 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). | The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments. | Posted | Mean | Standard Deviation | Score on a Scale | Week 6 post treatment administration |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Gingival and Interproximal MLSI at Week 3 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). | The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments. | Posted | Mean | Standard Deviation | Score on a Scale | Week 3 post treatment administration |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Gingival and Interproximal MLSI at Week 6 | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). | The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments. | Posted | Mean | Standard Deviation | Score on a Scale | Week 6 post treatment administration |
|
Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
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 | NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner. | 1 | 78 | 39 | 78 | ||
| EG001 | NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner. | 0 | 82 | 41 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| Ruptured Ovarian Cyst | Reproductive system and breast disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paraesthesia oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Glossodynia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Aphthous stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Sensitivity of teeth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tongue discolouration | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tongue ulceration | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cheilitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gingival bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gingival pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypoaesthesia oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral mucosal hypertrophy | Gastrointestinal disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Tension headache | Nervous system disorders | Systematic Assessment |
| ||
| Ageusia | Nervous system disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Oral herpes | Infections and infestations | Systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Tooth abscess | Infections and infestations | Systematic Assessment |
| ||
| Thermal burn | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Mouth injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Traumatic haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Back injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Tongue injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Device failure | General disorders | Systematic Assessment |
| ||
| Cyst rupture | General disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Ovarian cyst ruptured | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D012969 | Sodium Fluoride |
| C010882 | chlorhexidine gluconate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| 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 |
Not provided
Not provided
| Male |
|
| Superiority or Other |
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
|
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner. |
|
|
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner. |
|
|
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner. |
|
|
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner. |
|
|
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner. |
|
|
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner. |
|
|