Dental Plaque Removal Ability of Prototype Power Toothbrush Versus a Manual Toothbrush in Healthy Participants

NCT03809910 | Completed Phase 2 Results

• 1 other identifier: 208112
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the ability of a prototype power toothbrush (PTB) versus a manual toothbrush in healthy, right-handed manual toothbrush (MTB) participants with no signs of periodontal disease or excessive recession to remove dental plaque after a single tooth brushing event. Prior to each treatment visit, participants will abstain from oral hygiene for a period of 12 hours preceding a pre-brushing dental plaque evaluation. Participants will then brush once under supervision for 2 minutes in 'Gum line' mode and 1-minute in 'Interdental' mode after which re-disclosing and a post-brushing plaque assessment will be carried out.

Conditions

Dental Plaque

Keywords

Oral Health, Dental care, Lifestyle

Outcome Measures

Primary Outcomes (1)

• Change in Whole Mouth Rustogi Modified Navy Plaque Index (RMNPI) Score From Pre-Brushing to Post-Brushing (When Prototype Power Toothbrush [PTB] Was Used in 'Gumline' Mode vs a Reference Manual Toothbrush [MTB])

  Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (sites A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score).

  After 2 minutes of brushing

Secondary Outcomes (11)

• Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB)

  After 2 minutes of brushing

• Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB)

  After 2 minutes of brushing

• Change in Whole Mouth RMNPI Score From Pre-brushing to Post-brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)

  After 3 minutes of brushing

• Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)

  After 3 minutes of brushing

• Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)

  After 3 minutes of brushing

Study Arms (4)

Prototype PTB (Gum line mode)

EXPERIMENTAL

Participants will brush their teeth with prototype power toothbrush in Gum line mode with a fluoride toothpaste

Device: Prototype PTB (Gum line mode)

Prototype PTB (Combined mode)

EXPERIMENTAL

Participants will brush their teeth with prototype power toothbrush in "Gum line" mode with a fluoride toothpaste. Following this, participants will brush their teeth with prototype power toothbrush in 'Interdental' mode with a fluoride toothpaste.

Device: Prototype PTB (Combined mode)

Reference MTB

SHAM COMPARATOR

Participants will brush their teeth with manual toothbrush and fluoride toothpaste.

Device: Reference MTB

Reference PTB

ACTIVE COMPARATOR

Participants will brush their teeth with reference power toothbrush and fluoride toothpaste.

Device: Reference PTB

Interventions

Reference MTB DEVICE

Participants will brush their teeth with manual toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 1-timed minute under supervision of study staff.

Reference MTB

Reference PTB DEVICE

Participants will brush their teeth with power toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute under supervision of study staff.

Reference PTB

Prototype PTB (Gum line mode) DEVICE

Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in "Gum Line" mode under supervision of study staff.

Prototype PTB (Gum line mode)

Prototype PTB (Combined mode) DEVICE

Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in "Gum Line" mode and 1-timed minute in "Interdental" mode under supervision of study staff.

Prototype PTB (Combined mode)

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.
• Participant is male or female who, at the time of screening, is between the ages of 18 and 65 years, inclusive.
• A participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
• A participant that successfully completes the investigational device training visit, understands and is willing to follow product usage instructions, in the opinion of the investigator or designee.
• A participant in good general and mental health, in the opinion of the investigator or medically qualified designee; no clinically significant and relevant abnormalities in medical history or upon oral examination.
• A participant with good dental health based on medical history and oral soft tissue examination at screening.
• A participant with a minimum of 20 permanent gradable teeth (gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded).
• For continued eligibility after the Screening visit, a participant must have a mean RMNPI whole mouth plaque score of ≥ 0.6 at Visit 2, 3, 4 and 5.
• A participant that regularly uses a manual toothbrush in their daily oral hygiene routine.
• A participant that regularly brushes their teeth with their right hand.

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 a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; 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) within 30 days prior to study entry and/or 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 who is a pregnant female (evidenced by positive urine pregnancy test).
• A participant who is a breastfeeding female.
• A male participant able to father children or female participant of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for 5 days after the last assigned treatment.
• A female participant who is of childbearing potential and are sexually active and at risk for pregnancy must agree to use a highly effective method of contraception consistently and correctly for the duration of the active study period and for 5 days after the last assigned treatment.
• 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, in the opinion of the investigator or medically qualified designee, should not participate in the study.
• A participant unwilling or unable to comply with the following Lifestyle Considerations: a) Participants will be requested not to have any elective dental procedures including teeth professionally cleaned, excluding emergency dental treatment ; b)Participants will be requested not to have whitening treatment (including professional or at home use) during the duration of the study; c) Participants will not be permitted to use any other oral care products (i.e. oral rinses, tongue cleaners, whitening, bleaching products) besides the products supplied for this study; d) Eligible participants will be asked to stop using their regular dentifrice and toothbrush from the Screening visit for the duration of the study; e) Participants should abstain from interproximal cleaning (i.e. dental floss, oral irrigators, interdental brushes) for the duration of the study. Participants will be permitted to use toothpicks or floss to remove impacted food only ; f) Prior to Visit 2, 3 and 4:Participants should abstain from all oral hygiene procedures for at least12 hours prior to the scheduled time of their Visit 2, 3 and 4 appointments; g ) On study visit days (Visits 2, 3 and 4) participants must abstain from all food and drink (except water) at least 4 hours prior to their scheduled visits until all measurements have been taken. Water is permitted until 1 hour prior to investigational product administration; h) Participants must abstain from chewing gum and consuming confectionary containing xylitol (e.g. mints) at least 4 hours prior to their scheduled visit; i) On study visit days (Visits 2, 3 and 4) participants must abstain from all alcohol until all measurements have been taken; j) Participants will abstain from caffeine-containing products for at least 4 hours prior to their scheduled Visit 2, 3 and 4 until all measurements have been take; k) Participant will abstain from smoking, chewing tobacco, or smoking E-cigarettes throughout the study.
• A participant who has received a dental prophylaxis within 4 weeks of Screening visit.
• A participant who has received teeth bleaching/whitening (including professional or at home use) within 8 weeks prior to Screening visit.
• A participant who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening.
• A participant who has received orthodontic therapy or scaling or root planning within 3 months of Screening.
• A participant with high levels of extrinsic stain or calculus deposits which might interfere with dental plaque assessments.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Mississauga, L5N 6J2, Canada

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 18, 2019
• Study Start: July 8, 2019
• Primary Completion: August 9, 2019
• Study Completion: August 9, 2019
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-09

Locations

CA (1)