Efficacy of Three Experimental Toothpastes to Remove Plaque

• ClinicalTrials.gov Identifier: NCT02992691
• Recruitment Status: Completed
• First Posted: December 14, 2016
• Results First Posted: October 29, 2018
• Last Update Posted: May 29, 2019
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

The Dose response of three experimental toothpastes (test product 1, test product 2 and test product 3) to remove plaque after a single brushing, compared to a positive control and negative control dentifrice will be evaluated.

Condition or disease	Intervention/treatment	Phase
Dental Plaque	Drug: 20% w/w sodium bicarbonate; Drug: 35% w/w sodium bicarbonate; Drug: 50% w/w sodium bicarbonate; Drug: 67% w/w sodium bicarbonate; Drug: 0% w/w sodium bicarbonate	Not Applicable

Detailed Description:

This will be a single centre, controlled, examiner blind, five treatment, five period, crossover design study in healthy participants. This study will evaluate the dose response of three experimental toothpastes (test product 1, test product 2 and test product 3) to remove plaque after a single brushing, compared to a positive control and negative control dentifrice. Plaque removal efficacy will be measured by Turesky modification of Quigley Hein Plaque Index (TPI).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dose Response of Three Experimental Dentifrices in Plaque Removal in a Single Brushing Model
• Actual Study Start Date: December 19, 2016
• Actual Primary Completion Date: February 2, 2017
• Actual Study Completion Date: February 2, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Test Product 1; 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; Dentifrice containing 20% w/w sodium bicarbonate.
Experimental: Test Product 2; 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; Dentifrice containing 35% w/w sodium bicarbonate.
Experimental: Test Product 3; 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; Dentifrice containing 20% w/w sodium bicarbonate.
Active Comparator: Positive Control; 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; Dentifrice containing 67% w/w sodium bicarbonate.
Negative Control; Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.	Drug: 0% w/w sodium bicarbonate; Dentifrice containing 0% sodium bicarbonate and 1450 parts per million (ppm) fluoride.

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: Up to 5 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.

Secondary Outcome Measures :

1. 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) [ Time Frame: Up to 5 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.
2. 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 Positive Control) [ Time Frame: Up to 5 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 Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Germany

GSK Investigational Site

Schenefeld, Schleswig-Holstein, Germany, 22869

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:

Study Protocol  [PDF] January 17, 2018

Statistical Analysis Plan  [PDF] January 17, 2018

More Information

Additional Information:

Related Info 

Randomized Clinical Dose-Response Study to Evaluate Plaque Removal by Three Experimental Sodium Bicarbonate Toothpastes Using a Single Brushing Model. 

Publications of Results:

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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02992691
• Other Study ID Numbers: 206886
• First Posted: December 14, 2016
• Results First Posted: October 29, 2018
• Last Update Posted: May 29, 2019
• Last Verified: May 2019

Additional relevant MeSH terms:

Dental Plaque; Dental Deposits; Tooth Diseases; Stomatognathic Diseases