Last updated: 08/07/2020 11:00:14
Dental plaque removal ability of prototype power toothbrush versus a manual toothbrush in healthy participants
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline (pre-brushing to post-brushing) in RMNPI whole mouth score (sites A to I) (Prototype PTB [Gum line mode] versus a reference MTB) after a single brushing event
Timeframe: After 2 minutes
Secondary outcomes:
Mean change from baseline (pre-brushing to post-brushing) RMNPI marginal score (sites A to C) (Prototype PTB [Gum line mode] versus a reference MTB) after a single brushing event
Timeframe: After 2 minutes
Mean change from baseline (pre-brushing to post-brushing) RMNPI proximal score (sites D to F) (Prototype PTB [Gum line mode] versus a reference MTB) after a single brushing event
Timeframe: After 2 minutes
Mean change from baseline (pre-brushing to post-brushing) RMNPI whole mouth score (sites A to I) (Prototype PTB [combined mode] versus a reference MTB) after a single brushing event
Timeframe: After 3 minutes
Mean change from baseline (pre-brushing to post-brushing) RMNPI marginal score (sites A to C) (Prototype PTB [combined mode] versus a reference MTB) after a single brushing event
Timeframe: After 3 minutes
Mean change from baseline (pre-brushing to post-brushing) RMNPI proximal score (sites D to F) (Prototype PTB [combined mode] versus a reference MTB) after a single brushing event
Timeframe: After 3 minutes
Mean change from baseline (pre-brushing to post-brushing) RMNPI whole mouth score (sites A to I) of a Prototype PTB (Gum line mode versus Combined mode) after a single brushing event
Timeframe: After 3 minutes
Mean change from baseline (pre-brushing to post-brushing) RMNPI marginal score (sites A to C) of a Prototype PTB (Gum line mode versus Combined mode) after a single brushing event
Timeframe: After 3 minutes
Mean change from baseline (pre-brushing to post-brushing) RMNPI proximal score (sites D to F) of a Prototype PTB (Gum line mode versus Combined mode) after a single brushing event
Timeframe: After 3 minutes
Mean change from baseline (pre-brushing to post-brushing) RMNPI whole mouth score (sites A to I) (Prototype PTB [Gum line mode and Combined mode] versus a reference PTB) after a single brushing event
Timeframe: After 3 minutes
Mean change from baseline (pre-brushing to post-brushing) RMNPI marginal score (sites A to C) (Prototype PTB [Gum line mode and Combined mode] versus a reference PTB) after a single brushing event
Timeframe: After 3 minutes
Mean change from baseline (pre-brushing to post-brushing) RMNPI proximal score (sites D to F) (Prototype PTB [Gum line mode and Combined mode] versus a reference PTB) after a single brushing event
Timeframe: After 3 minutes
Interventions:
Device: Reference MTB
Device: Reference PTB
Device: Prototype PTB (Gum line mode)
Device: Prototype PTB (Combined mode)
Enrollment:
40
Observational study model:
Not applicable
Primary completion date:
2019-09-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dental Plaque
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2019 to August 2019
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2019-09-08
Actual study completion date
2019-09-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website