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Trial record 45 of 292 for:    Sodium Fluoride OR Duraphat

An Efficacy Study of Stain Control of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Tooth Staining

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ClinicalTrials.gov Identifier: NCT01962493
Recruitment Status : Completed
First Posted : October 14, 2013
Results First Posted : November 3, 2014
Last Update Posted : March 3, 2015
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 Oral Hygiene
Interventions Other: Sodium bicarbonate/ Sodium Fluoride
Other: Sodium fluoride
Drug: Chlorhexidine digluconate
Enrollment 160
Recruitment Details The study was conducted at two sites in the UK. Participants were recruited from the site's database and by use of advertisements.
Pre-assignment Details 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.
Arm/Group Title NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 78 82
Completed 73 77
Not Completed 5 5
Reason Not Completed
Adverse Event             1             2
Protocol Violation             0             1
Withdrawal by Subject             4             2
Arm/Group Title NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash NaF Toothpaste + Chlorhexidine Digluconate Mouthwash Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 78 82 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 82 participants 160 participants
39.8  (11.08) 39.5  (10.87) 39.6  (10.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 82 participants 160 participants
Female
56
  71.8%
60
  73.2%
116
  72.5%
Male
22
  28.2%
22
  26.8%
44
  27.5%
1.Primary Outcome
Title Modified Lobene Stain Index (MLSI) at Week 6
Hide Description 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).
Time Frame Week 6 post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 75 79
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
0.97  (0.929) 1.22  (1.008)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash, NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Comments Null hypothesis stated that there was no difference between treatment groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1313
Comments Analysis based on square root transformation. Results back transformed for interpretation.
Method ANCOVA
Comments Results were obtained from ANCOVA model with Site, Treatment, Treatment X Site, Smoking Status as fixed effects and baseline MLSI as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.51 to 0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.155
Estimation Comments Difference is first named treatment minus second named treatment. A negative difference favors the first named treatment
2.Secondary Outcome
Title Overall MLSI at Week 3
Hide Description 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).
Time Frame Week 3 post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 75 79
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
0.46  (0.572) 0.59  (0.563)
3.Secondary Outcome
Title Overall Facial MLSI at Week 3
Hide Description 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).
Time Frame Week 3 post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 75 79
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
0.27  (0.557) 0.41  (0.542)
4.Secondary Outcome
Title Overall Facial MLSI at Week 6
Hide Description 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).
Time Frame Week 6 post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 75 79
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
0.67  (0.885) 0.96  (0.992)
5.Secondary Outcome
Title Overall Interproximal MLSI at Week 3
Hide Description 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).
Time Frame Week 3 post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 75 79
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
0.66  (0.828) 0.87  (0.820)
6.Secondary Outcome
Title Overall Interproximal MLSI at Week 6
Hide Description 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).
Time Frame Week 6 post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 75 79
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
1.44  (1.396) 1.87  (1.525)
7.Secondary Outcome
Title Overall Gingival and Interproximal MLSI at Week 3
Hide Description 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).
Time Frame Week 3 post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 75 79
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
0.56  (0.713) 0.73  (0.711)
8.Secondary Outcome
Title Overall Gingival and Interproximal MLSI at Week 6
Hide Description 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).
Time Frame Week 6 post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 75 79
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
1.18  (1.134) 1.52  (1.271)
Time Frame Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Hide Arm/Group Description 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. 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.
All-Cause Mortality
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/78 (1.28%)      0/82 (0.00%)    
Infections and infestations     
Appendicitis   1/78 (1.28%)  1 0/82 (0.00%)  0
Reproductive system and breast disorders     
Ruptured Ovarian Cyst   1/78 (1.28%)  1 0/82 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/78 (50.00%)      41/82 (50.00%)    
Gastrointestinal disorders     
Paraesthesia oral   3/78 (3.85%)  3 4/82 (4.88%)  4
Glossodynia   2/78 (2.56%)  2 3/82 (3.66%)  4
Aphthous stomatitis   1/78 (1.28%)  1 1/82 (1.22%)  3
Sensitivity of teeth   2/78 (2.56%)  2 2/82 (2.44%)  2
Tongue discolouration   4/78 (5.13%)  4 0/82 (0.00%)  0
Tongue ulceration   0/78 (0.00%)  0 2/82 (2.44%)  3
Vomiting   2/78 (2.56%)  2 1/82 (1.22%)  1
Cheilitis   0/78 (0.00%)  0 2/82 (2.44%)  2
Nausea   1/78 (1.28%)  1 1/82 (1.22%)  1
Abdominal pain upper   0/78 (0.00%)  0 1/82 (1.22%)  1
Diarrhoea   1/78 (1.28%)  1 0/82 (0.00%)  0
Dyspepsia   1/78 (1.28%)  1 0/82 (0.00%)  0
Gastritis   1/78 (1.28%)  1 0/82 (0.00%)  0
Gastrooesophageal reflux disease   1/78 (1.28%)  1 0/82 (0.00%)  0
Gingival bleeding   0/78 (0.00%)  0 1/82 (1.22%)  1
Gingival pain   1/78 (1.28%)  1 0/82 (0.00%)  0
Hypoaesthesia oral   0/78 (0.00%)  0 1/82 (1.22%)  1
Oral mucosal hypertrophy   0/78 (0.00%)  0 1/82 (1.22%)  1
General disorders     
Device failure   1/78 (1.28%)  1 1/82 (1.22%)  1
Cyst rupture   1/78 (1.28%)  1 0/82 (0.00%)  0
Infections and infestations     
Upper respiratory tract infection   9/78 (11.54%)  9 8/82 (9.76%)  8
Pharyngitis   0/78 (0.00%)  0 3/82 (3.66%)  3
Oral herpes   0/78 (0.00%)  0 2/82 (2.44%)  2
Appendicitis   1/78 (1.28%)  1 0/82 (0.00%)  0
Influenza   0/78 (0.00%)  0 1/82 (1.22%)  1
Nasopharyngitis   1/78 (1.28%)  1 0/82 (0.00%)  0
Sinusitis   0/78 (0.00%)  0 1/82 (1.22%)  1
Tooth abscess   1/78 (1.28%)  1 0/82 (0.00%)  0
Injury, poisoning and procedural complications     
Thermal burn   3/78 (3.85%)  4 3/82 (3.66%)  3
Mouth injury   1/78 (1.28%)  1 2/82 (2.44%)  2
Ligament sprain   2/78 (2.56%)  2 0/82 (0.00%)  0
Procedural pain   2/78 (2.56%)  2 0/82 (0.00%)  0
Traumatic haemorrhage   1/78 (1.28%)  1 1/82 (1.22%)  1
Back injury   0/78 (0.00%)  0 1/82 (1.22%)  1
Tongue injury   0/78 (0.00%)  0 1/82 (1.22%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia   1/78 (1.28%)  1 0/82 (0.00%)  0
Back pain   0/78 (0.00%)  0 1/82 (1.22%)  1
Rotator cuff syndrome   0/78 (0.00%)  0 1/82 (1.22%)  1
Nervous system disorders     
Headache   13/78 (16.67%)  14 6/82 (7.32%)  9
Dysgeusia   1/78 (1.28%)  1 7/82 (8.54%)  7
Tension headache   4/78 (5.13%)  6 1/82 (1.22%)  1
Ageusia   1/78 (1.28%)  1 2/82 (2.44%)  2
Psychiatric disorders     
Insomnia   0/78 (0.00%)  0 1/82 (1.22%)  1
Reproductive system and breast disorders     
Dysmenorrhoea   1/78 (1.28%)  2 0/82 (0.00%)  0
Ovarian cyst ruptured   1/78 (1.28%)  1 0/82 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough   0/78 (0.00%)  0 1/82 (1.22%)  1
Oropharyngeal pain   0/78 (0.00%)  0 1/82 (1.22%)  1
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01962493     History of Changes
Other Study ID Numbers: 202182
RH01913 ( Other Identifier: GSK )
First Submitted: October 10, 2013
First Posted: October 14, 2013
Results First Submitted: July 17, 2014
Results First Posted: November 3, 2014
Last Update Posted: March 3, 2015