Trial Outcomes & Findings for Antimicrobial Agent for Reducing Bacteria in Aerosols and Oral Cavity (NCT NCT02319668)
NCT ID: NCT02319668
Last Updated: 2017-07-19
Results Overview
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.
COMPLETED
PHASE4
38 participants
At Day 3
2017-07-19
Participant Flow
Participants were recruited from the one center in the 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).
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
Other (Not specified)
|
0
|
2
|
Baseline Characteristics
Antimicrobial Agent for Reducing Bacteria in Aerosols and Oral Cavity
Baseline characteristics by cohort
| Measure |
Test and Reference Product
n=19 Participants
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).
|
Reference Product
n=19 Participants
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.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.5 Years
STANDARD_DEVIATION 8.74 • n=99 Participants
|
28.4 Years
STANDARD_DEVIATION 12.23 • n=107 Participants
|
27.9 Years
STANDARD_DEVIATION 10.50 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At Day 3Population: 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.
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.
Outcome measures
| Measure |
Test and Reference Product
n=19 Participants
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).
|
Reference Product
n=19 Participants
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.
|
|---|---|---|
|
Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery
|
7.63 log(10) colony forming equivalents (CFE)
Standard Deviation 0.501
|
7.43 log(10) colony forming equivalents (CFE)
Standard Deviation 0.598
|
SECONDARY outcome
Timeframe: At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7Population: 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.
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.
Outcome measures
| Measure |
Test and Reference Product
n=19 Participants
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).
|
Reference Product
n=19 Participants
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.
|
|---|---|---|
|
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)
At Day 0 (pre rinse), (n=19,19)
|
7.55 log (10) CFE
Standard Deviation 0.376
|
7.74 log (10) CFE
Standard Deviation 0.364
|
|
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)
At Day 0 (pre implant), (n=19, 18)
|
7.65 log (10) CFE
Standard Deviation 0.375
|
8.01 log (10) CFE
Standard Deviation 0.381
|
|
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)
At Day 0 (mid implant), (n=19, 18)
|
7.58 log (10) CFE
Standard Deviation 0.449
|
7.84 log (10) CFE
Standard Deviation 0.597
|
|
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)
At Day 0 (post implant), (n=19,18)
|
7.58 log (10) CFE
Standard Deviation 0.429
|
7.81 log (10) CFE
Standard Deviation 0.433
|
|
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)
At Day 1 (n=19, 17)
|
7.44 log (10) CFE
Standard Deviation 0.409
|
7.06 log (10) CFE
Standard Deviation 0.470
|
|
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)
At Day 7 (n=19, 17)
|
7.72 log (10) CFE
Standard Deviation 0.335
|
7.38 log (10) CFE
Standard Deviation 0.512
|
SECONDARY outcome
Timeframe: Up to 7 days post implant surgeryPopulation: 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.
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
Outcome measures
| Measure |
Test and Reference Product
n=19 Participants
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).
|
Reference Product
n=19 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) for the Total Number of Plaque Bacteria in the Mouth Post Implant Surgery
|
8.57 log (10) CFE × Day
Standard Deviation 0.319
|
8.37 log (10) CFE × Day
Standard Deviation 0.356
|
SECONDARY outcome
Timeframe: At BaselinePopulation: 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.
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
Outcome measures
| Measure |
Test and Reference Product
n=19 Participants
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).
|
Reference Product
n=19 Participants
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.
|
|---|---|---|
|
Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis
Pre prophylaxis
|
0.94 log (10) CFU/mL
Standard Deviation 0.435
|
0.91 log (10) CFU/mL
Standard Deviation 0.606
|
|
Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis
Post prophylaxis
|
1.31 log (10) CFU/mL
Standard Deviation 0.201
|
1.33 log (10) CFU/mL
Standard Deviation 0.326
|
Adverse Events
Test and Reference Product
Reference Product
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test and Reference Product
n=19 participants at risk
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).
|
Reference Product
n=19 participants at risk
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
84.2%
16/19
|
78.9%
15/19
|
|
Injury, poisoning and procedural complications
Procedural pain
|
10.5%
2/19
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
5.3%
1/19
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
5.3%
1/19
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/19
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.00%
0/19
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/19
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/19
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/19
|
15.8%
3/19
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/19
|
5.3%
1/19
|
|
Nervous system disorders
Headache
|
26.3%
5/19
|
5.3%
1/19
|
|
Nervous system disorders
Ageusia
|
5.3%
1/19
|
0.00%
0/19
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19
|
5.3%
1/19
|
|
Nervous system disorders
Tingue bitting
|
0.00%
0/19
|
5.3%
1/19
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
1/19
|
5.3%
1/19
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
1/19
|
0.00%
0/19
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.3%
1/19
|
0.00%
0/19
|
|
Gastrointestinal disorders
Lip exfoliation
|
5.3%
1/19
|
0.00%
0/19
|
|
Gastrointestinal disorders
Tongue discolouration
|
5.3%
1/19
|
0.00%
0/19
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/19
|
5.3%
1/19
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/19
|
5.3%
1/19
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/19
|
5.3%
1/19
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/19
|
5.3%
1/19
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/19
|
5.3%
1/19
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19
|
5.3%
1/19
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/19
|
5.3%
1/19
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/19
|
5.3%
1/19
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19
|
5.3%
1/19
|
|
Infections and infestations
Oral herpes
|
5.3%
1/19
|
0.00%
0/19
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/19
|
5.3%
1/19
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/19
|
5.3%
1/19
|
|
General disorders
Injury associated with device
|
5.3%
1/19
|
0.00%
0/19
|
|
General disorders
Asthenia
|
0.00%
0/19
|
5.3%
1/19
|
|
General disorders
Fatigue
|
0.00%
0/19
|
5.3%
1/19
|
|
General disorders
Implant site erythema
|
0.00%
0/19
|
10.5%
2/19
|
|
General disorders
Implant site haemorrhage
|
0.00%
0/19
|
5.3%
1/19
|
|
General disorders
Implant site pain
|
0.00%
0/19
|
5.3%
1/19
|
|
General disorders
Implant site swelling
|
0.00%
0/19
|
10.5%
2/19
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
1/19
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/19
|
5.3%
1/19
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.3%
1/19
|
5.3%
1/19
|
|
Eye disorders
Eye pain
|
0.00%
0/19
|
5.3%
1/19
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/19
|
5.3%
1/19
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/19
|
5.3%
1/19
|
|
Renal and urinary disorders
Urine ordour abnormal
|
0.00%
0/19
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngal pain
|
0.00%
0/19
|
10.5%
2/19
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/19
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/19
|
15.8%
3/19
|
|
Surgical and medical procedures
Pain prophylaxis
|
0.00%
0/19
|
5.3%
1/19
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER