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Antimicrobial Agent for Reducing Bacteria in Aerosols and Oral Cavity

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ClinicalTrials.gov Identifier: NCT02319668
Recruitment Status : Completed
First Posted : December 18, 2014
Results First Posted : April 17, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Prevention
Condition Dental Prophylaxis and Implant Surgery
Interventions Drug: 0.2% w/v Chlorhexidine digluconate
Drug: Sodium fluoride toothpaste (Aquafresh Mild & Minty)
Enrollment 38
Recruitment Details Participants were recruited from the one center in the United kingdom.
Pre-assignment Details 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).
Arm/Group Title Test and Reference Product Reference Product
Hide Arm/Group Description 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). 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.
Period Title: Overall Study
Started 19 19
Completed 19 17
Not Completed 0 2
Reason Not Completed
Other (Not specified)             0             2
Arm/Group Title Test and Reference Product Reference Product Total
Hide Arm/Group Description 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). 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 of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
Safety population: defined as all the participants who were randomised and received at least one dose of study treatment during the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
27.5  (8.74) 28.4  (12.23) 27.9  (10.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
9
  47.4%
10
  52.6%
19
  50.0%
Male
10
  52.6%
9
  47.4%
19
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Hispanic or Latino
1
   5.3%
2
  10.5%
3
   7.9%
Not Hispanic or Latino
18
  94.7%
17
  89.5%
35
  92.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.3%
1
   5.3%
2
   5.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
4
  21.1%
4
  10.5%
White
18
  94.7%
14
  73.7%
32
  84.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery
Hide Description 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.
Time Frame At Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Test and Reference Product Reference Product
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: log(10) colony forming equivalents (CFE)
7.63  (0.501) 7.43  (0.598)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test and Reference Product, Reference Product
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2965
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment as factor and baseline as covariate.
Method of Estimation Estimation Parameter Least square (LS) Mean difference
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-0.18 to 0.58
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.
2.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Test and Reference Products Reference Product
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: log (10) CFE
At Day 0 (pre rinse), (n=19,19) 7.55  (0.376) 7.74  (0.364)
At Day 0 (pre implant), (n=19, 18) 7.65  (0.375) 8.01  (0.381)
At Day 0 (mid implant), (n=19, 18) 7.58  (0.449) 7.84  (0.597)
At Day 0 (post implant), (n=19,18) 7.58  (0.429) 7.81  (0.433)
At Day 1 (n=19, 17) 7.44  (0.409) 7.06  (0.470)
At Day 7 (n=19, 17) 7.72  (0.335) 7.38  (0.512)
3.Secondary Outcome
Title Area Under the Curve (AUC) for the Total Number of Plaque Bacteria in the Mouth Post Implant Surgery
Hide Description 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
Time Frame Up to 7 days post implant surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Test and Reference Product Reference Product
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: log (10) CFE × Day
8.57  (0.319) 8.37  (0.356)
4.Secondary Outcome
Title Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis
Hide Description 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
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Test and Reference Product Reference Product
Hide Arm/Group Description:
Participants rinsed for one timed minute with 10 mL of Test product only (mouthwash containing Chlorhexidine digluconate). Participants did not receive reference product(toothpaste containing sodium fluoride) during analysis of this outcome as this analysis was performed at baseline.
Participants did not receive any product (mouthwash containing Chlorhexidine digluconate or toothpaste containing sodium fluoride) during analysis of this outcome as this analysis was performed at baseline.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: log (10) CFU/mL
Pre prophylaxis 0.94  (0.435) 0.91  (0.606)
Post prophylaxis 1.31  (0.201) 1.33  (0.326)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test and Reference Product Reference Product
Hide Arm/Group Description 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). 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.
All-Cause Mortality
Test and Reference Product Reference Product
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Test and Reference Product Reference Product
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Test and Reference Product Reference Product
Affected / at Risk (%) Affected / at Risk (%)
Total   17/19 (89.47%)   18/19 (94.74%) 
Eye disorders     
Eye pain   0/19 (0.00%)  1/19 (5.26%) 
Eyelid oedema   0/19 (0.00%)  1/19 (5.26%) 
Gastrointestinal disorders     
Abdominal pain upper   1/19 (5.26%)  1/19 (5.26%) 
Dry mouth   1/19 (5.26%)  0/19 (0.00%) 
Gingival bleeding   1/19 (5.26%)  0/19 (0.00%) 
Lip exfoliation   1/19 (5.26%)  0/19 (0.00%) 
Tongue discolouration   1/19 (5.26%)  0/19 (0.00%) 
Gingival pain   0/19 (0.00%)  1/19 (5.26%) 
Gingival swelling   0/19 (0.00%)  1/19 (5.26%) 
Lip dry   0/19 (0.00%)  1/19 (5.26%) 
Lip swelling   0/19 (0.00%)  1/19 (5.26%) 
Lip ulceration   0/19 (0.00%)  1/19 (5.26%) 
Nausea   0/19 (0.00%)  1/19 (5.26%) 
Oral mucosal erythema   0/19 (0.00%)  1/19 (5.26%) 
Toothache   0/19 (0.00%)  1/19 (5.26%) 
General disorders     
Injury associated with device   1/19 (5.26%)  0/19 (0.00%) 
Asthenia   0/19 (0.00%)  1/19 (5.26%) 
Fatigue   0/19 (0.00%)  1/19 (5.26%) 
Implant site erythema   0/19 (0.00%)  2/19 (10.53%) 
Implant site haemorrhage   0/19 (0.00%)  1/19 (5.26%) 
Implant site pain   0/19 (0.00%)  1/19 (5.26%) 
Implant site swelling   0/19 (0.00%)  2/19 (10.53%) 
Immune system disorders     
Seasonal allergy   0/19 (0.00%)  1/19 (5.26%) 
Infections and infestations     
Nasopharyngitis   1/19 (5.26%)  1/19 (5.26%) 
Oral herpes   1/19 (5.26%)  0/19 (0.00%) 
Angular cheilitis   0/19 (0.00%)  1/19 (5.26%) 
Tonsillitis   0/19 (0.00%)  1/19 (5.26%) 
Injury, poisoning and procedural complications     
Post procedural discomfort   16/19 (84.21%)  15/19 (78.95%) 
Procedural pain   2/19 (10.53%)  1/19 (5.26%) 
Post procedural complication   1/19 (5.26%)  0/19 (0.00%) 
Post procedural haemorrhage   1/19 (5.26%)  0/19 (0.00%) 
Eye contusion   0/19 (0.00%)  1/19 (5.26%) 
Incision site complication   0/19 (0.00%)  1/19 (5.26%) 
Incision site haemorrhage   0/19 (0.00%)  1/19 (5.26%) 
Mouth injury   0/19 (0.00%)  1/19 (5.26%) 
Post procedural swelling   0/19 (0.00%)  3/19 (15.79%) 
Thermal burn   0/19 (0.00%)  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain   1/19 (5.26%)  0/19 (0.00%) 
Pain in jaw   0/19 (0.00%)  1/19 (5.26%) 
Nervous system disorders     
Headache   5/19 (26.32%)  1/19 (5.26%) 
Ageusia   1/19 (5.26%)  0/19 (0.00%) 
Dizziness   0/19 (0.00%)  1/19 (5.26%) 
Tingue bitting   0/19 (0.00%)  1/19 (5.26%) 
Renal and urinary disorders     
Urine ordour abnormal   0/19 (0.00%)  1/19 (5.26%) 
Reproductive system and breast disorders     
Dysmenorrhoea   1/19 (5.26%)  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngal pain   0/19 (0.00%)  2/19 (10.53%) 
Skin and subcutaneous tissue disorders     
Ecchymosis   0/19 (0.00%)  1/19 (5.26%) 
Rash   0/19 (0.00%)  1/19 (5.26%) 
Swelling face   0/19 (0.00%)  3/19 (15.79%) 
Surgical and medical procedures     
Pain prophylaxis   0/19 (0.00%)  1/19 (5.26%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02319668     History of Changes
Other Study ID Numbers: 202200
2014-003222-40 ( EudraCT Number )
RH02604 ( Other Identifier: GSK )
First Submitted: December 15, 2014
First Posted: December 18, 2014
Results First Submitted: March 2, 2017
Results First Posted: April 17, 2017
Last Update Posted: July 19, 2017