Trial Outcomes & Findings for A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing (NCT NCT00964860)

Results Overview

Gingivitis was scored using the Lobene Modified Gingival Index (a visual examination for inflammation) on all scorable teeth. For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored on a 5-point, categorical scale (0 = absence of inflammation; 4 = severe inflammation) corresponding to Inflammation

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

60 participants

Primary outcome timeframe

30 days

Results posted on

2012-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Brushing Only Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice	Brushing + Flossing Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
Overall Study STARTED	30	30
Overall Study COMPLETED	30	29
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Brushing Only Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice	Brushing + Flossing Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brushing Only n=30 Participants Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice	Brushing + Flossing n=30 Participants Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss	Total n=60 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	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	29.0 years STANDARD_DEVIATION 7.8 • n=5 Participants	28.2 years STANDARD_DEVIATION 8.5 • n=7 Participants	28.6 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment Guatemala	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: per protocol

Gingivitis was scored using the Lobene Modified Gingival Index (a visual examination for inflammation) on all scorable teeth. For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored on a 5-point, categorical scale (0 = absence of inflammation; 4 = severe inflammation) corresponding to Inflammation

Outcome measures

Outcome measures
Measure	Brushing Only n=30 Participants Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice	Brushing + Flossing n=29 Participants Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group	2.11 units on a scale Standard Error 0.05	1.87 units on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: 30 days

Population: per protocol

Whole-mouth average MGI scores were calculated separately for each subject and visit by averaging the MGI scores of all gradable sites. Interpoximal average MGI scores were also calculated for each subject and visit by averaging over only interpoximal sites (buccal-mesial, buccal-distal, lingual-mesian, and lingual-distal). Within each treatment, changes from baseline were analyzed using paired t-test. Between treatments mean comparisons were conducted using analysis of covariance with baseline MGI score as a covariate. All statistical comparisons were two-sided with a 5% significance level. The average MGI score for a subject can range from 0 (no gingivitis) to 4 (inflammation on all gradable sites).

Outcome measures

Outcome measures
Measure	Brushing Only n=30 Participants Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice	Brushing + Flossing n=29 Participants Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group	2.06 units on a scale Standard Error 0.05	1.86 units on a scale Standard Error 0.05

Adverse Events

Brushing Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brushing + Flossing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Holly Eynon

Procter and Gamble

Phone: 513-622-2920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60