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Ability of Four Toothpastes to Remove Plaque

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ClinicalTrials.gov Identifier: NCT03285984
Recruitment Status : Completed
First Posted : September 18, 2017
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE September 12, 2017
First Posted Date  ICMJE September 18, 2017
Results First Submitted Date  ICMJE October 6, 2017
Results First Posted Date  ICMJE October 16, 2018
Last Update Posted Date October 16, 2018
Actual Study Start Date  ICMJE March 27, 2012
Actual Primary Completion Date May 8, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
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 [ Time Frame: Baseline to 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
Mean change from baseline (pre-brushing to post-brushing) in Turesky score after single supervised use (test product 1 versus [vs] Test product 4) [ Time Frame: Up to 4 weeks (at every week after single dentifrice use) ]
The dental examiner will use the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque will first be disclosed using a dye solution. Participants will rinse with disclosing solution. They will expectorate and rinse with 10 milliliters (ml)of water for 10 seconds (s) and expectorate again. Plaque will be assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque will be scored as follows :0 No plaque; 1 Slight flecks of plaque at the cervical margin of the tooth; 2 A thin continuous band of plaque (1 millimeters [mm] or smaller) at the cervical margin of the tooth; 3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4 Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth; 5 Plaque covering 2/3 or more of the crown of the tooth.
Change History Complete list of historical versions of study NCT03285984 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
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 [ Time Frame: Baseline to 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
Mean change from baseline (pre-brushing to post brushing) in Turesky score after single supervised use for Test products 1, 2, 3 and 4 [ Time Frame: Up to 4 weeks (at every week after single dentifrice use) ]
The dental examiner will use the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque will first be disclosed using a dye solution. Participants will rinse with disclosing solution. They will expectorate and rinse with 10 milliliters (ml)of water for 10 seconds (s) and expectorate again. Plaque will be assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque will be scored as follows :0 No plaque; 1 Slight flecks of plaque at the cervical margin of the tooth; 2 A thin continuous band of plaque (1 millimeters [mm] or smaller) at the cervical margin of the tooth; 3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4 Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth; 5 Plaque covering 2/3 or more of the crown of the tooth.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ability of Four Toothpastes to Remove Plaque
Official Title  ICMJE Plaque Removal Efficacy of Four Dentifrices in a Single Brushing Model
Brief Summary The aim of this study is to evaluate and compare the plaque removal efficacy of four experimental toothpastes following a single timed brushing. Prior to each treatment visit, participants will abstain from oral hygiene for a period of 24 hours (+6hrs, -2hrs), immediately preceding a pre-brushing dental plaque evaluation. Participants will then brush once under supervision for one timed minute with each dentifrice after which re-disclosing and a post-brushing plaque assessment will be carried out.
Detailed Description

This study will be a single centre, randomized, controlled, examiner blind, four treatment, four period crossover design. At the screening visit, following provision of written informed consent, eligible participants will be provided with a washout toothpaste and toothbrush for use at home during the study and for at least 14 days prior to the first treatment visit.

Participants will then be scheduled to attend the first of four treatment visits a minimum of 14 days later. For each treatment visit, participants must abstain from oral hygiene for a period of 24 hours (+6hrs, -2hrs), immediately preceding the pre-brushing dental plaque evaluation. All the participants will undergo an oral soft tissue (OST) examination followed by disclosing and a dental plaque assessment.

At the treatment visit 1 pre-brushing plaque assessment, those who develop a sufficient amount of plaque (Turesky mean score ≥ 2.00) will be randomized to study treatment. Participants will then brush once (1.5 grams [g] ± 0.05g of assigned toothpaste), under supervision of study staff for one timed minute, with one of the four test toothpastes after which re-disclosing and a post-brushing plaque assessment will be carried out. Participants will be allowed to brush with the washout paste following the post assessment plaque assessments.

A minimum of three days washout period will follow each treatment period during which period Participants will brush with a commercial washout toothpaste. Participants will complete four treatment visits and will brush once with each of the four test toothpastes throughout the course of the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
The randomization schedule will indicate the treatment order sequence. Each subject will complete all four treatment regimens, one treatment regimen in each of the four treatment periods. This randomization will use a Williams Square layout and be provided by the Biostatistics Department, GSKCH.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dental Plaque
Intervention  ICMJE
  • Other: 67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride
    Toothpaste containing 67 percent (%) Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride
  • Other: 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride
    Toothpaste containing 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride
  • Other: 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium
    Whitening Toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium
  • Other: 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride
    Toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride
Study Arms  ICMJE
  • Experimental: Test product 1
    Participants will brush once (1.5g ± 0.05g of Test product 1), under supervision of study staff for one timed minute
    Intervention: Other: 67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride
  • Experimental: Test product 2
    Participants will brush once (1.5g ± 0.05g of Test product 2), under supervision of study staff for one timed minute
    Intervention: Other: 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride
  • Experimental: Test product 3
    Participants will brush once (1.5g ± 0.05g of Test product 3), under supervision of study staff for one timed minute
    Intervention: Other: 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium
  • Experimental: Test product 4
    Participants will brush once (1.5g ± 0.05g of Test product 4), under supervision of study staff for one timed minute
    Intervention: Other: 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2017)
56
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 8, 2012
Actual Primary Completion Date May 8, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03285984
Other Study ID Numbers  ICMJE 202655
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP