Clinical trial NCT03809910: Dental Plaque Removal Ability of Prototype Power Toothbrush Versus a Manual Toothbrush in Healthy Participants
Official title: An Exploratory, Randomized, Single Center, Partial Crossover, Clinical Study to Evaluate the Dental Plaque Removal Ability of a Prototype Power Toothbrush Versus a Manual Toothbrush After a Single Tooth Brushing Event
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Plaque
Keywords: Oral Health, Dental care, Lifestyle
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2019-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Detailed description: This study is an exploratory, randomized, single center, 4-treatment, 3-period, partial crossover study in healthy participants with no signs of periodontal disease or excessive recession, to assess a prototype PTB in removing dental plaque after a single brushing event.

At the screening visit, following provision of written informed consent, participants will be provided PTB training to familiarize themselves with how the different modes and different PTBs operate. Eligible participants will be provided with a washout fluoride toothpaste and toothbrush for use at home during the study.

Participants will then be scheduled to attend appointment after a minimum of 3 days. For each treatment visit, participants must abstain from oral hygiene for a period of 12hours, immediately preceding the pre-brushing dental plaque evaluation.

All the participants will undergo an oral soft tissue (OST) examination followed by plaque disclosing and a pre-brushing dental plaque assessment using the Rustogi Modified Navy Plaque Index (RMNPI) index. In in periods 1 and 2, participants will be randomized to the study treatment sequence with the prototype PTB and MTB used in a crossover manner and participants will then brush under supervision followed by disclosing and post-brushing plaque assessments. Participants assigned to the prototype PTB, it will be used for 2 minutes in 'Gum line' mode brushing and 1-minute brushing in 'Interdental' mode.

Participants will then brush once (1.3 grams \[g\] ± 0.1 g of assigned toothpaste), under supervision of study staff after which 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 standard washout toothpaste

Eligibility criteria: Inclusion Criteria:

An individual must meet all the following inclusion criteria to be eligible for enrollment into the study:

* 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.

Exclusion Criteria:

An individual who meets any of the following exclusion criteria will not be eligible for enrollment into the study:

* 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.
* A participant that has current active caries, excessive gingival recession, severe gingivitis or periodontitis that may, in the opinion of the investigator, compromise the study or the oral health of the participant if they participate in the study.
* A participant with the presence of oral or peri-oral ulceration including herpetic lesions at the time of screening.
* A participant who is at risk of spasms.
* A participant with restorations in a poor state of repair that may, in the opinion of the investigator, compromise the study or the oral health of the participant if they participate in the study.
* A participant with the presence of orthodontic bands or appliances, extensive crowns, partial or full dentures, or fixed retainers on the maxillary or mandibular teeth.
* A participant with a tongue or lip piercing, or any other oral feature that could interfere with the usage of the toothbrush.
* A participant who has used antibiotic treatment within 14 days prior to Screening visit.
* A participant with diagnosed xerostomia or taking any medication that in view of the investigator causes xerostomia.
* A participant with any electronic medical devices (such as pacemakers).
* A participant that has used a chlorhexidine mouthwash within 14 days of Screening visit or used any oral care product that under the criteria of the principal investigator could interfere with dental plaque formation.
* A participant unwilling to abstain from using other oral care products besides those assigned to them in the study.
* A participant with a recent history (within past year) of alcohol or other substance abuse.
* A participant that smokes or uses chew tobacco, or regularly smokes E-cigarettes.
* A participant who has previously been enrolled in this study.

Primary outcomes:
measure: 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])
timeFrame: After 2 minutes of brushing
Secondary outcomes:
measure: Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB)
timeFrame: After 2 minutes of brushing
measure: Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB)
timeFrame: After 2 minutes of brushing
measure: Change in Whole Mouth RMNPI Score From Pre-brushing to Post-brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)
timeFrame: After 3 minutes of brushing
measure: Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)
timeFrame: After 3 minutes of brushing
measure: Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)
timeFrame: After 3 minutes of brushing
measure: Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)
timeFrame: After 3 minutes of brushing
measure: Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)
timeFrame: After 3 minutes of brushing
measure: Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)
timeFrame: After 3 minutes of brushing
measure: Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB)
timeFrame: After 3 minutes of brushing
measure: Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB)
timeFrame: After 3 minutes of brushing
measure: Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB)
timeFrame: After 3 minutes of brushing
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: