Evaluate Dental Plaque Benefit of a Preventive Treatment Gel | NCT03546491

NCT03546491

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Preventive Gel	Experimental	0.4% stannous fluoride	Drug: Preventive Gel
Marketed Control	Active Comparator	0.243 % Sodium Fluoride	Drug: Marketed Control

Name	Type	Description	Arm Group Labels	Other Names
Preventive Gel	Drug	0.4% Stannous Fluoride	Preventive Gel
Marketed Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Turesky Modified Quigley-Hein Index at Day 4	The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is 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 1 mm, 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.	Day 4

Secondary Outcomes

Measure	Description	Time Frame
Mean Turesky Modified Quigley-Hein Index at Baseline	The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is 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 1 mm, 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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
Be 18 years of age or older;
Agree not to participate in any other oral/dental product studies during the study;
Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
Agree to refrain from the use of any non-study oral hygiene products (subjects who are regular flossers will be allowed to floss during acclimation and wash-out periods);
Agree to use an oral hygiene product that contains stannous fluoride;
Agree to refrain from any form of non-specified oral hygiene during the treatment period, including the use of products such as floss, toothpicks for plaque removal, and chewing gum;
Agree to refrain from any oral hygiene, eating and drinking after 11:00 PM the evening before plaque measurements on Day 0 and Day 4 of the treatment periods;
Agree to return for all scheduled visits and follow study procedures;
Possess a minimum of 20 natural teeth with scorable facial and lingual surfaces, of which at least 4 are molars; and,
Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.

Exclusion Criteria:• Have a medical condition requiring pre-medication prior to dental procedures;

Have taken antibiotics within 2 weeks of the acclimation period or anticipate taking antibiotics at any time during the study;
Have a history of allergies or hypersensitivity to dyes or dentifrices that contain stannous fluoride;
Have removable or orthodontic appliances which interfere with obtaining 20 gradable teeth;
Have previously demonstrated an inability to comply with study visit requirements;
Have rampant caries, open or untreated caries, severe gingivitis or advanced periodontitis requiring prompt treatment; or,
Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study.

Facility	Status	City	State	ZIP	Country	Contacts
Oral Health Science Center		Mason	Ohio	45040	United States

Arm/Group Information

ID	Title	Description
FG000	Overall Study	This was a single center, controlled, examiner-blind, randomized, 2-treatment, 3-period cross-over 4-day partial brushing plaque study. Each participant received Test product 1 (0.4% stannous fluoride preventive gel), and Test product 2 (marketed 0.243% sodium fluoride toothpaste). All subjects saw each test product at least 1 time, for the third period, each subject saw either Test product 1 or Test product 2 for a second time.

Baseline Characteristics Module

ID	Title	Description
BG000	Overall Study	This was a controlled, examiner-blind, randomized, 2-treatment, 3-period cross-over 4-day partial brushing plaque study.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Turesky Modified Quigley-Hein Index at Day 4

The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is 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 1 mm, 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.

Posted

Mean

Standard Error

score on a scale

Day 4

ID	Title	Description
OG000	Preventive Gel

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Preventive Gel	0.4% stannous fluoride preventive gel	0

ID	Term
D003741	Dental Deposits
D014076	Tooth Diseases
D009057	Stomatognathic Diseases