Trial Outcomes & Findings for Bad Breath Response to Tongue Scraper and Rinses (NCT NCT00867035)

Results Overview

2 investigators are trained to evaluate smell using the Rosenberg scale which measures foul smelling breath. The Rosenberg scale is validated and is scored 0-5 with 0= no bad breath, 5=worst bad breath. A score of 2 is the threshold at which bad breath is determined.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

baseline, 1 hour, 2 hours, 4 hours, 1 week

Results posted on

2013-05-16

Participant Flow

Screening in dental clinic March 2008-March 2009. With organoleptic(OLT)score of 2 or more, or 75parts per billion(ppb) hydrogen sulfide(H2S), subjects invited to enter clinical trial. Subjects numbered in sequence from a computer-generated table of random numbers.

Exclusions: 1)Inability to return for evaluation, 2)inability to follow directions, 3) afflicted with systemic disease involving volatile sulfur compounds (VSC), 4)currently taking antibiotics, 5) using medicine in syrup form, 6) advanced periodontal disease, 7) smoker.

Participant milestones

Participant milestones
Measure	Chlorine Dioxide Rinse and Tongue Scraper 20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day	Chlorhexidene Rinse and Tongue Scraper 20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
Baseline to 1 Hour STARTED	13	9
Baseline to 1 Hour COMPLETED	12	8
Baseline to 1 Hour NOT COMPLETED	1	1
Baseline to 2 Hours STARTED	12	8
Baseline to 2 Hours COMPLETED	12	8
Baseline to 2 Hours NOT COMPLETED	0	0
Baseline to 4 Hours STARTED	12	8
Baseline to 4 Hours COMPLETED	12	8
Baseline to 4 Hours NOT COMPLETED	0	0
Baseline to 1 Week STARTED	12	8
Baseline to 1 Week COMPLETED	11	8
Baseline to 1 Week NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Chlorine Dioxide Rinse and Tongue Scraper 20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day	Chlorhexidene Rinse and Tongue Scraper 20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
Baseline to 1 Hour Withdrawal by Subject	1	1
Baseline to 1 Week Withdrawal by Subject	1	0

Baseline Characteristics

Bad Breath Response to Tongue Scraper and Rinses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chlorine Dioxide Rinse and Tongue Scraper n=13 Participants 20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day	Chlorhexidene Rinse and Tongue Scraper n=9 Participants 20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	9 participants n=7 Participants	22 participants n=5 Participants
Rosenberg score of 2 or more	13 participants n=5 Participants	9 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 1 hour, 2 hours, 4 hours, 1 week

Population: two judges score breath odor by Rosenberg scale 0 to 5. Score of 2 is threshold for malodor. participants randomly assigned, ITT.

2 investigators are trained to evaluate smell using the Rosenberg scale which measures foul smelling breath. The Rosenberg scale is validated and is scored 0-5 with 0= no bad breath, 5=worst bad breath. A score of 2 is the threshold at which bad breath is determined.

Outcome measures

Outcome measures
Measure	Chlorine Dioxide Rinse and Tongue Scraper n=13 Participants 20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day	Chlorhexidene Rinse and Tongue Scraper n=9 Participants 20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
Percentage of Participants With Rosenberg Score at Indicated Time Points Percentage with score of 0 or 1 at 1 hour	79 percentage of participants	100 percentage of participants
Percentage of Participants With Rosenberg Score at Indicated Time Points Percentage with score of 0 or 1 at 2 hours	79 percentage of participants	94 percentage of participants
Percentage of Participants With Rosenberg Score at Indicated Time Points Percentage with score of 0 or 1 at 4 hours	54 percentage of participants	81 percentage of participants
Percentage of Participants With Rosenberg Score at Indicated Time Points Percentage with score of 0 or 1 at 1 week	64 percentage of participants	81 percentage of participants
Percentage of Participants With Rosenberg Score at Indicated Time Points Percentage with score of 2 or 3 at Baseline	96 percentage of participants	74 percentage of participants