Ability of Four Toothpastes to Remove Plaque

NCT03285984 | Completed Results

• 1 other identifier: 202655
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• 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

  Baseline to 4 Weeks

Study Arms (4)

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

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

Test product 1

67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride OTHER

Toothpaste containing 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride

Test product 2

62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium OTHER

Whitening Toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium

Test product 3

0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride OTHER

Toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride

Test product 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• 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.

  PMID: 29971158 DERIVED

MeSH Terms

Conditions

Dental Plaque

Interventions

Sodium Bicarbonate; Sodium Fluoride

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 18, 2017
• Study Start: March 27, 2012
• Primary Completion: May 8, 2012
• Study Completion: May 8, 2012
• Last Updated: October 16, 2018
• Results First Posted: October 16, 2018

Record last verified: 2018-10