Efficacy of Manual Toothbrushes in Removing Dental Plaque

NCT04025684 | Completed Results

• 1 other identifier: 212224
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical methodology development study will evaluate the plaque removal efficacy of four marketed manual toothbrushes, with differing bristle types and brush head designs, in healthy dentate participants. Changes in supra-gingival plaque accumulation will be assessed after first use and following 1-and 4-weeks treatment (twice-daily brushing), using two different clinical measures of dental plaque. Study participants will abstain from oral hygiene for a period of 12-18 hours prior to each assessment visit. Data generated will inform the design of future clinical studies investigating the plaque removal efficacy of manual toothbrushes.

Conditions

Dental Plaque; Oral Hygiene

Keywords

Oral Hygiene

Outcome Measures

Primary Outcomes (2)

• Change From Pre to Post Brushing in Overall Mean Rustogi Modified Navy Plaque Index (RPI) After a Single Brushing Event at Day 0

  Supra-gingival plaque was assessed on the facial and lingual surfaces of the teeth (7-7 each arch) using RPI. Each tooth surface was divided into 9 zones, for a total of 18 sites per tooth (A to I facial with 9 sites and lingual with 9 sites separately); A to C along gingival margin; D to F directly above A to C (D and F being inter-proximal zones); G to H across middle of tooth; and I covered incisal area. Plaque was disclosed and presence or absence of plaque in each zone was recorded as per scoring criteria: 0-Plaque absent, 1-Plaque present; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Change from pre-brushing = (post-brushing score - pre-brushing score). Overall mean calculated for all participants was reported.

  At Day 0

• Change From Pre to Post Brushing in Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) After a Single Brushing Event at Day 0

  Supra-gingival plaque accumulation was assessed on facial and lingual surfaces of teeth (7-7 in each arch) using TPI. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces and scored for each site on a scale of 0 to 5: 0-No plaque, 1-Slight flecks of plaque at cervical margin of tooth, 2-Thin, continuous band of plaque (1millimetre \[mm\] or smaller) at cervical margin of tooth, 3-Band of plaque wider than 1mm but covering less than 1/3 of area, 4-Plaque covering at least 1/3 but less than 2/3 of area, 5-Plaque covering 2/3 or more of crown of tooth; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Change from pre-brushing = (post-brushing score - pre-brushing score). Overall mean calculated for all participants was reported.

  At Day 0

Secondary Outcomes (15)

• Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Overall Mean Rustogi Modified Navy Plaque Index (RPI) at Day 7 and Day 28

  At Day 0, Day 7 and Day 28

• Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) at Day 7 and Day 28

  At Day 0, Day 7 and Day 28

• Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28

  At Day 7 and Day 28

• Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 7, and Day 28

  At Day 7 and Day 28

• Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Gingival Margin Sites Mean Rustogi Modified Navy Plaque Index (RPI) at Day 0, Day 7 and Day 28

  At Day 0, Day 7 and Day 28

Study Arms (4)

Test toothbrush 1

OTHER

Participants will brush their entire dentition twice daily (morning and evening) for 1-timed minute with test toothbrush 1 after applying a strip of standard fluoride (1450 parts per million \[ppm\] fluoride) toothpaste (full brush head) and will then rinse with 10 mL of water post brushing for 5 seconds (on site). Offsite participants will be permitted to rinse with tap water according to their normal habitat.

Other: Oral B Indicator 123

Test toothbrush 2

OTHER

Participants will brush their entire dentition twice daily (morning and evening) for 1-timed minute with test toothbrush 2 after applying a strip of standard fluoride (1450 ppm fluoride) toothpaste (full brush head) and will then rinse with 10 mL of water post brushing for 5 seconds (on site). Offsite participants will be permitted to rinse with tap water according to their normal habitat.

Other: Dr Best Original

Test toothbrush 3

OTHER

Participants will brush their entire dentition twice daily (morning and evening) for 1-timed minute with test toothbrush 3 after applying a strip of standard fluoride (1450 ppm fluoride) toothpaste (full brush head) and will then rinse with 10 mL of water post brushing for 5 seconds (on site). Offsite participants will be permitted to rinse with tap water according to their normal habitat.

Other: Dr Best Multi Expert

Test toothbrush 4

OTHER

Participants will brush their entire dentition twice daily (morning and evening) for 1-timed minute with test toothbrush 4 after applying a strip of standard fluoride (1450 ppm fluoride) toothpaste (full brush head) and will then rinse with 10 mL of water post brushing for 5 seconds (on site). Offsite participants will be permitted to rinse with tap water according to their normal habitat.

Other: parodontax Interdental

Interventions

Oral B Indicator 123 OTHER

Manual toothbrush (medium bristle stiffness; compact head, UK market).

Test toothbrush 1

Dr Best Original OTHER

Manual toothbrush (medium bristle stiffness; regular head, German market)

Test toothbrush 2

Dr Best Multi Expert OTHER

Manual toothbrush (medium bristle stiffness; compact head, German market)

Test toothbrush 3

parodontax Interdental OTHER

Manual toothbrush (soft bristle stiffness; compact head, German market)

Test toothbrush 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:

• Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
• A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures.
• A participant in good general, mental and oral health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, well-being or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
• A participant with, in the opinion of the investigator or medically qualified designee, satisfactory oral hygiene based on oral examination.
• A participant who routinely uses a manual toothbrush for daily oral hygiene.
• VISIT 1 (Screening): A participant must have a) ≥ 20 natural, permanent teeth b) ≥ 40 gradable tooth surfaces (≥ 2/3rds of the tooth surface assessable for RPI).Third molars, fully crowned/ extensively restored, grossly carious, orthodontically-banded/bonded or abutment teeth and surfaces with calculus deposits which, in the opinion of the clinical examiner, would interfere with plaque assessment should not be included in the gradable surface count. Third molars can be included if, as a result tooth loss, they are functioning as second molars.
• VISIT 2 (Baseline): A participant must have a pre-brushing mean RPI ≥ 0.6 overall (that is, the mean over all gradable surfaces)

You may not qualify if:

• A participant who is an employee of the investigational site, either directly involved in the conduct of the study or otherwise supervised by the investigator, or a member of their immediate family; or a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
• A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) in the 30 days prior to study entry and/or who is participating in other studies during study participation.
• A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
• A participant with any medical/oral condition which, in the opinion of the investigator or medically qualified designee, could impact study outcomes (for example, oral dryness).
• A participant taking daily doses of medication/having daily treatments which, in the opinion of the investigator or medically qualified designee, could impact study outcomes (for example, is causing oral dryness).
• A participant with any condition or physical limitation which, in the opinion of the investigator or medically qualified designee, impacts their ability to perform oral hygiene with a manual toothbrush.
• A participant who is pregnant (self-reported; no pregnancy test required) or intending to become pregnant over the course of the study.
• A participant who is breastfeeding.
• A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• A participant who is unwilling or unable to comply with the following Lifestyle Considerations described in this protocol: 1) Dental Product/Treatment and Oral Hygiene Restrictions i)From Screening (Visit 1) to the Participant's Last Study Visit: a) Participants should not use any other oral care products (for example, toothpastes, toothbrushes, oral rinses, tongue cleaners, whitening/bleaching products, inter-dental cleaning products)than those provided during the study. Note: dental floss (non-antibacterial) can be used to remove impacted food; b) Participants should not chew gum or consume any confectionery containing xylitol (e.g. sugar-free mints); c) Participants should delay any non-emergency dental treatment until after study completion (including dental prophylaxis); d)Participants should delay any tooth whitening treatments (professional and/or home use) until after study completion; ii) Before Clinical Efficacy Assessment Visits (Visits 2-4): Participants should refrain from oral hygiene procedures for 12-18 hours before their visit; 2) Meals and Dietary Restrictions i) Before Clinical Efficacy Assessment Visits (Visits 2-4): Participants should not eat or drink for ≥ 1 hour before their visit and until all visit procedures have been completed.
• A participant who has had routine dental prophylaxis within 4 weeks of Screening.
• A participant who has undergone a tooth bleaching procedure within 8 weeks of Screening.
• A participant with, in the opinion of the investigator or medically qualified designee, generalized moderate/severe gingivitis.
• A participant with, in the opinion of the investigator or medically qualified designee, gross periodontal disease.
• A participant with, in the opinion of the investigator or medically qualified designee, signs of active periodontitis.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Birmingham, West Midlands, B5 7EG, United Kingdom

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

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
• Masking Details: Examiner-blind; Monitor and Data-analyst
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: September 30, 2019
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: January 28, 2021
• Results First Posted: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of primary endpoints of the study.
• Access Criteria: Access is provided after a research proposal submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

GB (1)