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

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ClinicalTrials.gov Identifier: NCT03809910
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Dental Plaque Device: Reference MTB Device: Reference PTB Device: Prototype PTB (Gum line mode) Device: Prototype PTB (Combined mode) Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : May 8, 2019
Estimated Primary Completion Date : May 29, 2019
Estimated Study Completion Date : May 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: Prototype PTB (Gum line mode)
Participants will brush their teeth with prototype power toothbrush in Gum line mode with a fluoride toothpaste
Device: Prototype PTB (Gum line mode)
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.

Experimental: Prototype PTB (Combined mode)
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)
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.

Sham Comparator: Reference MTB
Participants will brush their teeth with manual toothbrush and fluoride toothpaste.
Device: Reference MTB
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.

Active Comparator: Reference PTB
Participants will brush their teeth with reference power toothbrush and fluoride toothpaste.
Device: Reference PTB
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.




Primary Outcome Measures :
  1. 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 [ Time Frame: After 2 minutes ]

    Pre-brushing and post brushing plaque measurements will be evaluated using RMNPI as either present or absent (1 or 0) on each of the nine areas of the buccal and each of the nine areas of the lingual tooth surfaces. RMNPI scores will be calculated on a whole mouth basis (sites A-I), along the gingival margin (sites A, B, C) and proximal (sites D and F).

    Each tooth section will be scored on scale 0-1, where 0 represents no dental plaque and 1 represents dental plaque. Lower values (i.e. 0) represents better dental hygiene.



Secondary Outcome Measures :
  1. 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 [ Time Frame: After 2 minutes ]
    Pre-brushing and post brushing plaque measurements will be evaluated using RMNPI as either present or absent (1 or 0) on each of the nine areas of the buccal and each of the nine areas of the lingual tooth surfaces. RMNPI scores will be calculated along the gingival margin (sites A, B, C). Each tooth section will be scored on scale 0-1, where 0 represents no dental plaque and 1 represents dental plaque. Lower values (i.e. 0) represents better dental hygiene.

  2. 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 [ Time Frame: After 2 minutes ]

    Pre-brushing and post brushing plaque measurements will be evaluated using RMNPI as either present or absent (1 or 0) on each of the nine areas of the buccal and each of the nine areas of the lingual tooth surfaces. RMNPI scores will be calculated along the proximal sites (D and F).

    Each tooth section will be scored on scale 0-1, where 0 represents no dental plaque and 1 represents dental plaque. Lower values (i.e. 0) represents better dental hygiene.


  3. 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 [ Time Frame: After 3 minutes ]

    Pre-brushing and post brushing plaque measurements will be evaluated using RMNPI as either present or absent (1 or 0) on each of the nine areas of the buccal and each of the nine areas of the lingual tooth surfaces. RMNPI scores will be calculated on a whole mouth basis (sites A-I), along the gingival margin (sites A, B, C) and proximal (sites D and F).

    Each tooth section will be scored on scale 0-1, where 0 represents no dental plaque and 1 represents dental plaque. Lower values (i.e. 0) represents better dental hygiene.


  4. 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 [ Time Frame: After 3 minutes ]

    Pre-brushing and post brushing plaque measurements will be evaluated using RMNPI as either present or absent (1 or 0) on each of the nine areas of the buccal and each of the nine areas of the lingual tooth surfaces. RMNPI scores will be calculated along the gingival margin (sites A, B, C).

    Each tooth section will be scored on scale 0-1, where 0 represents no dental plaque and 1 represents dental plaque. Lower values (i.e. 0) represents better dental hygiene.


  5. 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 [ Time Frame: After 3 minutes ]

    Pre-brushing and post brushing plaque measurements will be evaluated using RMNPI as either present or absent (1 or 0) on each of the nine areas of the buccal and each of the nine areas of the lingual tooth surfaces. RMNPI scores will be calculated along the proximal (sites D and F).

    Each tooth section will be scored on scale 0-1, where 0 represents no dental plaque and 1 represents dental plaque. Lower values (i.e. 0) represents better dental hygiene.


  6. 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 [ Time Frame: After 3 minutes ]

    Pre-brushing and post brushing plaque measurements will be evaluated using RMNPI as either present or absent (1 or 0) on each of the nine areas of the buccal and each of the nine areas of the lingual tooth surfaces. RMNPI scores will be calculated on a whole mouth basis (sites A-I), along the gingival margin (sites A, B, C) and proximal (sites D and F).

    Each tooth section will be scored on scale 0-1, where 0 represents no dental plaque and 1 represents dental plaque. Lower values (i.e. 0) represents better dental hygiene.


  7. 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 [ Time Frame: After 3 minutes ]

    Pre-brushing and post brushing plaque measurements will be evaluated using RMNPI as either present or absent (1 or 0) on each of the nine areas of the buccal and each of the nine areas of the lingual tooth surfaces. RMNPI scores will be calculated along the gingival margin (sites A, B, C).

    Each tooth section will be scored on scale 0-1, where 0 represents no dental plaque and 1 represents dental plaque. Lower values (i.e. 0) represents better dental hygiene.


  8. 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 [ Time Frame: After 3 minutes ]

    Pre-brushing and post brushing plaque measurements will be evaluated using RMNPI as either present or absent (1 or 0) on each of the nine areas of the buccal and each of the nine areas of the lingual tooth surfaces. RMNPI scores will be calculated along the proximal sites (D and F).

    Each tooth section will be scored on scale 0-1, where 0 represents no dental plaque and 1 represents dental plaque. Lower values (i.e. 0) represents better dental hygiene.


  9. 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 [ Time Frame: After 3 minutes ]

    Pre-brushing and post brushing plaque measurements will be evaluated using RMNPI as either present or absent (1 or 0) on each of the nine areas of the buccal and each of the nine areas of the lingual tooth surfaces. RMNPI scores will be calculated on a whole mouth basis (sites A-I), along the gingival margin (sites A, B, C) and proximal (sites D and F).

    Each tooth section will be scored on scale 0-1, where 0 represents no dental plaque and 1 represents dental plaque. Lower values (i.e. 0) represents better dental hygiene.


  10. 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 [ Time Frame: After 3 minutes ]

    Pre-brushing and post brushing plaque measurements will be evaluated using RMNPI as either present or absent (1 or 0) on each of the nine areas of the buccal and each of the nine areas of the lingual tooth surfaces. RMNPI scores will be calculated along the gingival margin (sites A, B, C).

    Each tooth section will be scored on scale 0-1, where 0 represents no dental plaque and 1 represents dental plaque. Lower values (i.e. 0) represents better dental hygiene.


  11. 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 [ Time Frame: After 3 minutes ]

    Pre-brushing and post brushing plaque measurements will be evaluated using RMNPI as either present or absent (1 or 0) on each of the nine areas of the buccal and each of the nine areas of the lingual tooth surfaces. RMNPI scores will be calculated along the proximal (sites D and F).

    Each tooth section will be scored on scale 0-1, where 0 represents no dental plaque and 1 represents dental plaque. Lower values (i.e. 0) represents better dental hygiene.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809910


Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Canada
GSK Investigational Site Not yet recruiting
Mississauga, Canada, L5N 6J
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03809910     History of Changes
Other Study ID Numbers: 208112
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Oral Health, Dental care, Lifestyle

Additional relevant MeSH terms:
Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorophosphate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs