Efficacy of Three Experimental Toothpastes to Remove Plaque | NCT02992691

NCT02992691

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

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Product 1	Experimental	Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.	Drug: 20% w/w sodium bicarbonate
Test Product 2	Experimental	Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.	Drug: 35% w/w sodium bicarbonate
Test Product 3	Experimental	Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.	Drug: 50% w/w sodium bicarbonate
Positive Control	Active Comparator	Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.	Drug: 67% w/w sodium bicarbonate
Negative Control	Other	Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.

Name	Type	Description	Arm Group Labels	Other Names
20% w/w sodium bicarbonate	Drug	Dentifrice containing 20% w/w sodium bicarbonate.	Test Product 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (TPI), Positive Control Versus [vs.] Negative Control	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.	Up to 5 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (Test Product 1, 2 and 3 vs Negative Control)	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 procedures, restrictions 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 between 18- 65 years
Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination. Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
Good dental health based on medical history and oral soft tissue examination at screening, a minimum of 20 permanent gradable teeth (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface to be graded), and mean Turesky plaque score of ≥ 2.00 at Visit 1 and Visit 2 (pre-brushing plaque assessment).
Understands and is willing, able and likely to comply with all study procedures and restrictions.

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.
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Participation in another clinical study: cosmetic studies within 14 days of the screening visit or receipt of an investigational drug within 30 days of the screening visit and previous participation in this study.
Recent history (within the last year) of alcohol or other substance abuse.
An employee of the sponsor or the study site or members of their immediate family and an employee of any toothpaste manufacturer or their immediate family.
Antibiotic treatment within 14 days prior to Visit 2 or throughout the study, any other treatment that would interfere with the study outcomes, at the discretion of the examiner or investigator.
High levels of extrinsic stain or calculus deposits which might interfere with plaque assessments at the discretion of the investigator, dental conditions / disease requiring immediate treatment, pre-existing sensitivity to oral care products, severe gingivitis that may, in the opinion of the investigator, compromise the study or the oral health of the participants if they participate in the study, presence of orthodontic bands or appliances, extensive crowns, partial dentures, or fixed retainers on the maxillary or mandibular teeth, active carious lesions needing immediate care, 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, have current active caries or periodontitis that may, in the opinion of the investigator, compromise the study or the oral health of the participants if they participate in the study, restorations in a poor state of repair that may, in the opinion of the investigator, compromise the study or the oral health of the participants if they participate in the study, use of a chlorhexidine mouthwash within 14 days of Visit 2 or through the study and current use of Listerine, Corsodyl or any antimicrobial mouth rinse or throughout the study.
Participant unwilling to abstain from using chewing tobacco (with or without tobacco) and Participant unwilling to abstain from smoking tobacco or E-cigarettes for 4 hours prior to all visits and until all dental assessments are completed at each visit.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Schenefeld	Schleswig-Holstein	22869	Germany

PubMed Identifier	Type	Citation	Retractions
30942962	Result	Jose A, Parkinson CR, Manger C, Bielfeldt S, Krause C. Randomized Clinical Dose-Response Study to Evaluate Plaque Removal by Three Experimental Sodium Bicarbonate Toothpastes Using a Single Brushing Model. J Clin Dent. 2018 Dec;29(4):75-80.

Label	URL
Related Info	View source

ID	Title	Description
FG000	Overall Study	This was a single-center, controlled, examiner-blind, five-treatment, five-period, crossover design study in healthy volunteers. Each participant received Test Product 1 (Dentifrice containing 20 percent [%] weight by weight [w/w] sodium bicarbonate), Test product 2 (Dentifrice containing 35% w/w sodium bicarbonate) Test product 3 (Dentifrice containing 50% w/w sodium bicarbonate), positive control (Dentifrice containing 67% w/w sodium bicarbonate) and negative control (Dentifrice containing 0% sodium bicarbonate and 1450 parts per million (ppm) fluoride).

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Overall Study	This was five-treatment, five-period, crossover design study. Each participant received Test Product 1 (Dentifrice containing 20 percent [%] weight by weight [w/w] sodium bicarbonate), Test product 2 (Dentifrice containing 35% w/w sodium bicarbonate) Test product 3 (Dentifrice containing 50% w/w sodium bicarbonate), positive control (Dentifrice containing 67% w/w sodium bicarbonate) and negative control (Dentifrice containing 0% sodium bicarbonate and 1450 parts per million [ppm] fluoride).

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

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	Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (TPI), Positive Control Versus [vs.] Negative Control	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.	Intent to treat (ITT) population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.	Posted		Mean	Standard Deviation	Score on a Scale		Up to 5 weeks

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	Test Product 1	Participant applied a full ribbon of dentifrice containing 20% w/w sodium bicarbonate and brushed their teeth for one timed minute.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 17, 2018	Jan 17, 2018	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Jan 17, 2018	Jan 17, 2018	SAP_001.pdf

ID	Term
D003741	Dental Deposits
D014076	Tooth Diseases
D009057	Stomatognathic Diseases