Phase 2
N=39
Dental Plaque Removal Ability of Prototype Power Toothbrush Versus a Manual Toothbrush in Healthy Participants
Dental Plaque
Bottom Line
View on ClinicalTrials.gov: NCT03809910 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: 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]) — -0.38; -0.32 Score on a scale — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Reference MTB (Device); Reference PTB (Device); Prototype PTB (Gum line mode) (Device); Prototype PTB (Combined mode) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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]) |
-0.38; -0.32 | <.0001 sig |
| SECONDARY Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB) |
-0.50; -0.38 | <0.0001 sig |
| SECONDARY Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB) |
-0.66; -0.55 | <0.0001 sig |
| SECONDARY Change in Whole Mouth RMNPI Score From Pre-brushing to Post-brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB) |
-0.54; -0.32 | <0.0001 sig |
| SECONDARY Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB) |
-0.76; -0.38 | <0.0001 sig |
| SECONDARY Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB) |
-0.90; -0.55 | <0.0001 sig |
| SECONDARY Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode) |
-0.38; -0.54 | <0.0001 sig |
| SECONDARY Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode) |
-0.50; -0.76 | <0.0001 sig |
| SECONDARY Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode) |
-0.66; -0.90 | <0.0001 sig |
| SECONDARY 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) |
-0.38; -0.54; -0.50 | <0.0001 sig |
| SECONDARY 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) |
-0.50; -0.76; -0.67 | <0.0001 sig |
| SECONDARY 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) |
-0.66; -0.90; -0.86 | <0.0001 sig |
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.
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 (i
Data sourced from ClinicalTrials.gov (NCT03809910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.