Ability of Four Toothpastes to Remove Plaque | NCT03285984

NCT03285984

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test product 1	Experimental	Participants will brush once (1.5g ± 0.05g of Test product 1), under supervision of study staff for one timed minute	Other: 67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride
Test product 2	Experimental	Participants will brush once (1.5g ± 0.05g of Test product 2), under supervision of study staff for one timed minute	Other: 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride
Test product 3	Experimental	Participants will brush once (1.5g ± 0.05g of Test product 3), under supervision of study staff for one timed minute	Other: 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium
Test product 4	Experimental	Participants will brush once (1.5g ± 0.05g of Test product 4), under supervision of study staff for one timed minute	Other: 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride	Other	Toothpaste containing 67 percent (%) Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline (Pre-brushing to Post-brushing) in Turesky Score After Single Supervised Use (Test Product 1 Versus [vs] Test Product 4) After 4 Weeks	The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 milliliters (mL) water for 10 seconds (sec),expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.	Baseline to 4 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline (Pre-brushing to Post Brushing) in Turesky Score After Single Supervised Use for Test Products 1, 2, 3 and 4 After 4 Weeks	The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 mL of water for 10 sec,expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Aged at least 18 years
Understands and is willing, able and likely to comply with all study procedures and restrictions
Good general health with (in the opinion of the Investigator) no clinically significant and relevant abnormalities of medical history or dental history.
Good dental health based on medical history and oral soft tissue examination at screening
At least 20 gradable, natural, uncrowned teeth with both facial and lingual scoreable surfaces (gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded)
Plaque Score: Mean Turesky plaque score of ≥ 2.00 at treatment visit 1 pre-brushing plaque assessment

Exclusion Criteria:

Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
Women who are breast-feeding
Antibiotic treatment within 14 days prior to Treatment Visit 1 or throughout the study
Any other treatment that would interfere with the study results/conduct, at the discretion of the examiner or investigator
Diabetes mellitus type I or II
Any disease systemic or localized, dental or non dental, which could put the participant's health at risk or interfere with the study results/conduct, at the discretion of the examiner or investigator
High levels of extrinsic stain or calculus deposits which might interfere with plaque assessments
Dental condition/ disease requiring immediate treatment
Pre-existing sensitivity to oral care products
Severe gingivitis
Periodontitis with pocket depth > 5mm affecting more than two teeth
Moderate or severe recession
Presence of orthodontic bands or appliances, extensive crowns, partial dentures, or fixed retainers on the maxillary or mandibular teeth
Obvious active carious lesions needing immediate care
Intra-oral decorative tattoos, or tongue and or lip piercing
Oral lesions/manifestations that would impact on the outcome of the study
Presence of oral or peri-oral ulceration including herpetic lesions at the time of screening or at baseline
Known or suspected intolerance or hypersensitivity to the studymaterials (or closely related compounds) or any of their stated ingredients
Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
Previous participation in this study
Recent history (within the last year) of alcohol or other substance abuse
Current use of Listerine or any antimicrobial mouth rinse containing Chlorhexidine or Cetrylpyridinium Chloride (CPC)
Participant unwilling to abstain from using chewing tobacco (with or without tobacco)
Participant unwilling to abstain from smoking on the morning prior to treatment visits
An employee of the sponsor or the study site or members of their immediate family

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

PubMed Identifier	Type	Citation	Retractions
29971158	Derived	Bosma ML, Milleman KR, Akwagyiram I, Targett D, Milleman JL. A randomised controlled trial to evaluate the plaque removal efficacy of sodium bicarbonate dentifrices in a single brushing clinical model. BDJ Open. 2018 Jun 4;4:17037. doi: 10.1038/s41405-018-0003-7. eCollection 2018.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Overall Study	This was a single centre, randomized, controlled, examiner blind, four treatment, four period crossover design study. Each Participant received Test product 1 (Toothpaste containing 67 percent [%] sodium bicarbonate with 6 herbs plus 923 parts per million [ppm] sodium fluoride, Test product 2 (Toothpaste containing 67% sodium bicarbonate without herbs plus 923ppm sodium fluoride), Test product 3 (Whitening Toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% weight by weight [w/w] silica plus 923ppm Sodium), and Test product 4 (Toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm sodium fluoride).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	All Randomized Participants	All randomized participants were included for baseline evaluation.

Units	Counts
Participants	BG00056

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 Change From Baseline (Pre-brushing to Post-brushing) in Turesky Score After Single Supervised Use (Test Product 1 Versus [vs] Test Product 4) After 4 Weeks

The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 milliliters (mL) water for 10 seconds (sec),expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.

ITT (Intent-to-treat) population was the primary analysis population, which included all the participants who were randomized and had at least one post-baseline efficacy evaluation.

Posted

Mean

Standard Deviation

Score on a scale

Baseline to 4 Weeks

ID	Title	Description
OG000	Test Product 1	Participants brushed once (1.5g ± 0.05g of toothpaste containing 67 % sodium bicarbonate with 6 herbs plus 923 ppm sodium fluoride), under supervision of study staff for one timed minute.
OG001	Test Product 4	Participants brushed once (1.5g ± 0.05g of toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.

Units	Counts
Participants	OG00056 OG00156

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0002.90± 0.308 OG0012.86± 0.309

Post Baseline

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		<.0001	From ANCOVA model with factors for treatment group, period and subject (random effect), and subject-level baseline and period-level baseline	Mean Difference (Net)	-0.21			2-Sided	95	-0.27	-0.15			Difference is first named treatment minus second-named treatment such that a negative difference favors the first named treatment		Superiority

Secondary

Mean Change From Baseline (Pre-brushing to Post Brushing) in Turesky Score After Single Supervised Use for Test Products 1, 2, 3 and 4 After 4 Weeks

The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 mL of water for 10 sec,expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.