Trial Outcomes & Findings for Measuring Efficacy of an Oral-Irrigator After Three Weeks of Use (NCT NCT04899440)

Last Updated: 2022-08-01

Results Overview

Modified Gingival Index score after 3 weeks of product use. Gingivitis will be scored on the buccal and lingual marginal gingival and interdental papilla of all scorable teeth (six scores per tooth):0 = normal (absence of inflammation); 1 = mild inflammation (slight change of color, little change in texture) of any portion of the gingival unit; 2 = mild inflammation of the entire gingival unit; 3 = moderate inflammation (moderate glazing, redness, edema and/or hypertrophy) of the gingival unit; 4 = severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding or ulceration) of the gingival unit. MGI whole mouth score is computed by summing the scores and dividing by the number of scorable sites examined.

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

MGI Score after 3 weeks of product use.

Results posted on

2022-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Test Regimen Oral Irrigator + Manual toothbrush + toothpaste Subjects will brush their teeth twice daily and will use the oral irrigator once in the evening daily Water Flosser: A pressurized stream of water to reduce gingivitis and remove adherent plaque	Control Regimen Manual toothbrush + toothpaste Subjects will brush their teeth twice daily Control: No Oral Irrigator Control
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Measuring Efficacy of an Oral-Irrigator After Three Weeks of Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Regimen n=15 Participants Oral Irrigator + Manual toothbrush + toothpaste Subjects will brush their teeth twice daily and will use the oral irrigator once in the evening daily Water Flosser: A pressurized stream of water to reduce gingivitis and remove adherent plaque	Control Regimen n=15 Participants Manual toothbrush + toothpaste Subjects will brush their teeth twice daily Control: No Oral Irrigator Control	Total n=30 Participants Total of all reporting groups
Age, Continuous	47.2 years STANDARD_DEVIATION 15.61 • n=5 Participants	49.2 years STANDARD_DEVIATION 13.04 • n=7 Participants	48.2 years STANDARD_DEVIATION 14.17 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: MGI Score after 3 weeks of product use.

Outcome measures

Outcome measures
Measure	Test Regimen n=15 Participants Oral Irrigator + Manual toothbrush + toothpaste Subjects will brush their teeth twice daily and will use the oral irrigator once in the evening daily Water Flosser: A pressurized stream of water to reduce gingivitis and remove adherent plaque	Control Regimen n=15 Participants Manual toothbrush + toothpaste Subjects will brush their teeth twice daily Control: No Oral Irrigator Control
MGI-Modified Gingival Index	0.30 score on a scale Standard Error 0.081	-0.13 score on a scale Standard Error 0.047

PRIMARY outcome

Timeframe: GBI score after 3 weeks of product use.

Gingival Bleeding Index score after 3 weeks of product use. Each of the 3 gingival areas, i.e., buccal, mesial/dystal and lingual, of the teeth will be probed in this manner waiting approximately 30 seconds before recording the number of gingival units which bleed, according to the following scale: 0 = absence of bleeding after 30 seconds; 1 = bleeding observed after 30 seconds; 2 = immediate bleeding observed. GBI whole mouth score is computed by summing the scores and dividing by the number of scorable sites examined.

Outcome measures

Outcome measures
Measure	Test Regimen n=15 Participants Oral Irrigator + Manual toothbrush + toothpaste Subjects will brush their teeth twice daily and will use the oral irrigator once in the evening daily Water Flosser: A pressurized stream of water to reduce gingivitis and remove adherent plaque	Control Regimen n=15 Participants Manual toothbrush + toothpaste Subjects will brush their teeth twice daily Control: No Oral Irrigator Control
GBI-Gingival Bleeding Index	0.16 score on a scale Standard Error 0.017	-0.06 score on a scale Standard Error 0.030

SECONDARY outcome

Timeframe: TMQHP score after 3 weeks of product use.

Turesky Modified Quigley-Hein Plaque Index score after 3 weeks of product use. The plaque deposits on the buccal, lingual, and whole mouth average plaque scores will be calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. Scoring criteria are shown below. 0=No Plaque; 1=Separate flecks of plaque at the cervical margin; 2=A thin, continuous band of plaque (up to 1 mm) at the cervical margin; 3=A band of plaque wider than 1mm, but covering less than one third of the side of the crown of the tooth; 4=Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; 5=Plaque covering two thirds or more of the side of the crown of the tooth; 8=Ungradable site; 9=Missing tooth

Outcome measures

Outcome measures
Measure	Test Regimen n=15 Participants Oral Irrigator + Manual toothbrush + toothpaste Subjects will brush their teeth twice daily and will use the oral irrigator once in the evening daily Water Flosser: A pressurized stream of water to reduce gingivitis and remove adherent plaque	Control Regimen n=15 Participants Manual toothbrush + toothpaste Subjects will brush their teeth twice daily Control: No Oral Irrigator Control
Plaque- TMQHP	0.28 score on a scale Standard Error 0.038	0.10 score on a scale Standard Error 0.048

Adverse Events

Test Regimen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Regimen

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

Clinical Trial Manager

Procter & Gamble

Phone: 5136225362

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER