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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003222-40 | EudraCT Number | ||
| RH02604 | Other Identifier | GSK |
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The primary objective of this study will be to evaluate the effect of two week pre-surgical rinsing with an antimicrobial mouthrinse containing 0.2% w/v Chlorhexidine digluconate on the total number of plaque bacteria in the mouth 3 days post implant surgery. The study will be conducted at Eastman Clinical Investigation Centre (ECIC), University College London (UCL) Eastman Dental Institute. Participants will be those who require a single and simple surgical implant to be placed, and will be recruited from new patient referrals within the Eastman Dental Hospital
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Experimental | Mouthwash containing 0.2% w/v Chlorhexidine digluconate |
|
| Control | Placebo Comparator | Sodium fluoride toothpaste (Aquafresh Mild & Minty) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.2% w/v Chlorhexidine digluconate | Drug | Participants will brush their teeth with the reference product (toothpaste) and thoroughly rinse their mouth with water and wait 5 timed minutes before using 10 ml of the 0.2% w/v Chlorhexidine digluconate mouthwash, except when using at site, where no brushing will take place prior to using the mouthrinse. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery | The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The number of bacteria in each of the three identified plaque sampling sites (surgical site, contralateral site to the surgical site and tongue) for each participant were summed to calculate the total number of bacteria for each participant. | At Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Detectable Plaque Bacteria Sampled at Implant Surgery (at Pre-rinse, Pre, Mid and Post Implant Surgery) and Post Implant Surgery (at Day 1 and 7) | The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. |
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Inclusion Criteria:
Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Aged between 18-64 years old.
Understands and is willing, able and likely to comply with all study procedures and restrictions
Good general and mental health with, in the opinion of the investigator or medically qualified designee:
Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception
Dental Health
Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | London | WC1X 8LD | United Kingdom |
A total of 44 participants were screened, out of which 38 were randomized. 6 participants were not randomized: 2 participants did not met study criteria, 2 participants withdrew their consent, 1 participant due to protocol violation, and 1 participant due to other reason (not specified).
Participants were recruited from the one center in the United kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test and Reference Product | Participants rinsed for one timed minute with 10 milliliter (mL) of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash). |
| FG001 | Reference Product | Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety population: defined as all the participants who were randomised and received at least one dose of study treatment during the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test and Reference Product | Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash). |
| 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 | Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery | The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The number of bacteria in each of the three identified plaque sampling sites (surgical site, contralateral site to the surgical site and tongue) for each participant were summed to calculate the total number of bacteria for each participant. | Intent to treat (ITT) population (N=38): defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | log(10) colony forming equivalents (CFE) | At Day 3 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test and Reference Product | Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brushed prior to using mouthwash). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post procedural discomfort | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| Sodium fluoride toothpaste (Aquafresh Mild & Minty) | Drug | Participants will apply a strip of toothpaste to cover the head of the toothbrush and will brush in their usual manner for two timed minutes twice daily. They will then rinse their mouth thoroughly with water after brushing |
|
| At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7 |
| Area Under the Curve (AUC) for the Total Number of Plaque Bacteria in the Mouth Post Implant Surgery | The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The AUC of the total count of detectable plaque bacteria was calculated using trapezoidal rule in the time range from immediately post implant surgery to 7 days post implant surgery | Up to 7 days post implant surgery |
| Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis | Thick settle blood agar plates (supplemented with 5% [volume by volume v/v]) defibrinated horse blood) were used to determine the bacterial load of the aerosol. Thirty (30) minutes prior to the participants had their procedure (dental prophylaxis), a total of 5 settle plates with lids removed were placed at set positions around the dental surgery. After 30 minutes, the settle plates lids were replaced. This was repeated during the dental prophylaxis procedure using 5 fresh settle plates. All plates were then sealed with parafilm and transported for incubation in an anaerobic chamber at 37°C for 3 days. The plates were inspected daily to access growth and after 3 days removed and stored at 4°C for subsequent colony enumeration and Colony Forming Unit/mL (CFU/mL) calculation | At Baseline |
| BG001 | Reference Product | Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Test and Reference Product | Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash). |
| OG001 | Reference Product | Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing. |
|
|
|
| Secondary | Total Number of Detectable Plaque Bacteria Sampled at Implant Surgery (at Pre-rinse, Pre, Mid and Post Implant Surgery) and Post Implant Surgery (at Day 1 and 7) | The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. | ITT (N=38) defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. n was number of participants evaluated at specific endpoint. | Posted | Mean | Standard Deviation | log (10) CFE | At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7 |
|
|
|
| Secondary | Area Under the Curve (AUC) for the Total Number of Plaque Bacteria in the Mouth Post Implant Surgery | The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The AUC of the total count of detectable plaque bacteria was calculated using trapezoidal rule in the time range from immediately post implant surgery to 7 days post implant surgery | ITT (N=38) defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | log (10) CFE × Day | Up to 7 days post implant surgery |
|
|
|
| Secondary | Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis | Thick settle blood agar plates (supplemented with 5% [volume by volume v/v]) defibrinated horse blood) were used to determine the bacterial load of the aerosol. Thirty (30) minutes prior to the participants had their procedure (dental prophylaxis), a total of 5 settle plates with lids removed were placed at set positions around the dental surgery. After 30 minutes, the settle plates lids were replaced. This was repeated during the dental prophylaxis procedure using 5 fresh settle plates. All plates were then sealed with parafilm and transported for incubation in an anaerobic chamber at 37°C for 3 days. The plates were inspected daily to access growth and after 3 days removed and stored at 4°C for subsequent colony enumeration and Colony Forming Unit/mL (CFU/mL) calculation | ITT (N=38) defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | log (10) CFU/mL | At Baseline |
|
|
|
| 0 |
| 19 |
| 17 |
| 19 |
| EG001 | Reference Product | Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing. | 0 | 19 | 18 | 19 |
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Eye contusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Incision site complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Incision site haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Mouth injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post procedural swelling | Injury, poisoning and procedural complications | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Ageusia | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Tingue bitting | Nervous system disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | Systematic Assessment |
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| Lip exfoliation | Gastrointestinal disorders | Systematic Assessment |
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| Tongue discolouration | Gastrointestinal disorders | Systematic Assessment |
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| Gingival pain | Gastrointestinal disorders | Systematic Assessment |
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| Gingival swelling | Gastrointestinal disorders | Systematic Assessment |
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| Lip dry | Gastrointestinal disorders | Systematic Assessment |
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| Lip swelling | Gastrointestinal disorders | Systematic Assessment |
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| Lip ulceration | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Oral mucosal erythema | Gastrointestinal disorders | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Oral herpes | Infections and infestations | Systematic Assessment |
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| Angular cheilitis | Infections and infestations | Systematic Assessment |
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| Tonsillitis | Infections and infestations | Systematic Assessment |
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| Injury associated with device | General disorders | Systematic Assessment |
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| Asthenia | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Implant site erythema | General disorders | Systematic Assessment |
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| Implant site haemorrhage | General disorders | Systematic Assessment |
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| Implant site pain | General disorders | Systematic Assessment |
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| Implant site swelling | General disorders | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
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| Eye pain | Eye disorders | Systematic Assessment |
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| Eyelid oedema | Eye disorders | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | Systematic Assessment |
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| Urine ordour abnormal | Renal and urinary disorders | Systematic Assessment |
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| Oropharyngal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Swelling face | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pain prophylaxis | Surgical and medical procedures | Systematic Assessment |
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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.
| At Day 0 (mid implant), (n=19, 18) |
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| At Day 0 (post implant), (n=19,18) |
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| At Day 1 (n=19, 17) |
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| At Day 7 (n=19, 17) |
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