N/A
N=80
Efficacy of Manual Toothbrushes in Removing Dental Plaque
Dental Plaque · Oral Hygiene
Bottom Line
View on ClinicalTrials.gov: NCT04025684 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change From Pre to Post Brushing in Overall Mean Rustogi Modified Navy Plaque Index (RPI) After a Single Brushing Event at Day 0 — -0.09623; -0.12005; -0.09859; -0.09599 score on a scale — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Oral B Indicator 123 (Other); Dr Best Original (Other); Dr Best Multi Expert (Other); parodontax Interdental (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Pre to Post Brushing in Overall Mean Rustogi Modified Navy Plaque Index (RPI) After a Single Brushing Event at Day 0 |
-0.09623; -0.12005; -0.09859; -0.09599 | <.0001 sig |
| PRIMARY Change From Pre to Post Brushing in Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) After a Single Brushing Event at Day 0 |
-0.49354; -0.62218; -0.57721; -0.53714 | <0.0001 sig |
| SECONDARY 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 |
-0.13485; -0.16648; -0.09813; -0.11839; -0.14738; -0.16234 | — |
| SECONDARY 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 |
-0.71646; -0.90569; -0.63582; -0.61935; -0.75755; -0.79959 | — |
| SECONDARY Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28 |
0.443; 0.438; 0.468; 0.449; 0.352; 0.333 | — |
| SECONDARY Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 7, and Day 28 |
2.361; 2.368; 2.508; 2.446; 1.803; 1.669 | — |
| SECONDARY 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 |
-0.04938; -0.09034; -0.05344; -0.07211; -0.12498; -0.16961 | — |
| SECONDARY Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Inter-Proximal Sites Mean Rustogi Modified Navy Plaque Index (RPI) at Day 0, Day 7 and Day 28 |
-0.26809; -0.28219; -0.25775; -0.22865; -0.31485; -0.33171 | — |
| SECONDARY Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Inter-Proximal Sites Mean Turesky Modified Quigley & Hein Plaque Index (TPI) at Day 0, Day 7 and Day 28 |
-0.49949; -0.60975; -0.58666; -0.49861; -0.72054; -0.89035 | — |
| SECONDARY Gingival Margin Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28 |
0.988; 0.987; 0.992; 0.981; 0.939; 0.896 | — |
| SECONDARY Inter-Proximal Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28 |
0.523; 0.499; 0.507; 0.467; 0.255; 0.217 | — |
| SECONDARY Inter-Proximal Sites Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 0, Day 7 and Day 28 |
2.643; 2.649; 2.737; 2.552; 2.141; 2.041 | — |
| SECONDARY Change From Baseline (Day 0 Pre-Brushing) in Overall Rustogi Modified Navy Plaque Index (RPI) at Day 7 Pre-brushing and Day 28 Pre-brushing |
-0.04465; -0.06178; -0.01992; -0.02163; -0.04420; -0.03796 | — |
| SECONDARY Change From Baseline (Day 0 Pre-Brushing) in Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) at Day 7 Pre-brushing and Day 28 Pre-brushing |
-0.15663; -0.20746; -0.07029; 0.01187; -0.19667; -0.12896 | — |
| SECONDARY Change From Baseline (Day 0 Pre-Brushing) in Gingival Margin Sites Mean Rustogi Modified Navy Plaque Index (RPI) at Day 7 Pre-brushing and Day 28 Pre-brushing |
-0.02233; -0.03645; -0.01378; -0.01219; -0.04272; -0.01355 | — |
| SECONDARY Change From Baseline (Day 0 Pre-Brushing) in Inter-Proximal Sites Mean Rustogi Modified Navy Plaque Index (RPI) at Day 7 Pre-brushing and Day 28 Pre-brushing |
-0.13944; -0.15199; -0.05413; -0.05919; -0.09970; -0.09659 | — |
| SECONDARY Change From Baseline (Day 0 Pre-Brushing) in Inter-Proximal Sites Mean Turesky Modified Quigley & Hein Plaque Index (TPI) at Day 7 Pre-brushing and Day 28 Pre-brushing |
-0.17652; -0.21666; -0.10226; 0.02326; -0.25042; -0.17761 | — |
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.
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.
- 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)
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 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 de
Data sourced from ClinicalTrials.gov (NCT04025684). 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.