Condition category
Oral Health
Date applied
03/09/2020
Date assigned
03/09/2020
Last edited
03/09/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Control of supragingival (above the gumline) plaque is essential for effective oral hygiene. Oral hygiene devices such as toothbrushes are under continuous review for effectiveness and safety as new devices or improvements of features on existing devices are developed. The aim of this study is to assess the plaque removal effectiveness of a new manual toothbrush with a replaceable brush head against a marketed manual brush.

Who can participate?
Generally healthy adults with evidence of plaque

What does the study involve?
Participants will be randomly assigned to one of four treatment sequences. Every participant will use each of the two toothbrushes (either a new manual toothbrush with a replaceable brush head or a regular manual toothbrush) twice. At each visit (period 1 to period 4), dental plaque will be measured before and after brushing. Participants will be instructed to refrain from brushing their teeth for 24 hours before their appointment times for all visits. All participants will be instructed to use their regular home oral hygiene products for the duration of the study in between visits.

What are the possible benefits and risks of participating?
Products will be returned at the end of the study. Both manual toothbrushes and the dentifrice provided in this study are currently marketed. The risk from chemical or mechanical hazards is negligible, or no greater than what would have been encountered during daily life. This study will involve the use of toothbrushes with toothpaste as part of a normal oral hygiene routine. No behavior with incremental risk will be requested from participants. In addition, their participation will help in the development of products that aim to improve oral health. Taking part in this study poses minimal risk to participants.

Where is the study run from?
All Sum Research Ltd (Canada)

When is the study starting and how long is it expected to run for?
October 2020, planned duration: 2 weeks

Who is funding the study?
Procter and Gamble Company (USA)

Who is the main contact?
Dr Chhaju Ram Goyal, DDS
crgoyal@allsumrc.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chhaju Ram Goyal

ORCID ID

Contact details

All Sum Research Center Ltd.
6635 Kitimat Rd. #36 & #37
Mississauga
L5N 6J2
Canada
+ 1 (0)905 812 1099
crgoyal@allsumrc.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Clinical Protocol 2020100

Study information

Scientific title

A study to compare the plaque removal efficacy of a new manual toothbrush with replaceable brush heads to a positive control manual toothbrush

Acronym

Study hypothesis

The purpose of this study is to assess the plaque removal efficacy of a new manual toothbrush with a replaceable brush head against a marketed manual brush using the extended Turesky Modified Quigley-Hein Index (TQHPI).

Ethics approval

Approved 31/08/2020, Veritas IRB Inc. (8555 Transcanada Hwy, Suite 201, Montreal, Quebec, H4S 1Z6, Canada; +1 (0)514 337 0442; Nathalie Hamzeh nhamzeh@veritasirb.com), ref: 16602-09:37:0928-08-2020

Study design

Single-center randomized controlled examiner-blind two-treatment cross-over study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

General healthy adults with evidence of overnight dental plaque

Intervention

Every participant will use each of the two toothbrushes (either new manual toothbrush with a replaceable brush head or a regular manual toothbrush) twice. Participants will be randomly assigned to one of four treatment sequences (ABBA, BAAB, AABB, BBAA) according to a computer-generated randomization plan prepared in advance of study execution, where A and B are the two test toothbrushes. Both products will be used with a regular marketed dentifrice. Interventions will be scheduled at Day 1, Day 3, Day 5, and Day 7 (minimum of 48 h washout in between visits). At each visit participants will be instructed to brush their teeth with the assigned toothbrush for 1 minute in their customary manner. All participants will be instructed to use their regular home oral hygiene products for the duration of the study in between visits. Dental plaque measurements will be taken at each visit (pre- and post-brushing).

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

Dental plaque (pre- and post-brushing) measured using the Turesky Modified Quigley-Hein Plaque Index (TQHPI) at each visit (Day 1, Day 3, Day 5, and Day 7)

Secondary outcome measures

Dental plaque measured using a new exploratory plaque index at each visit (Day 1, Day 3, Day 5, and Day 7, pre- and post-brushing) in the age group of 7-9-year-old children

Overall trial start date

19/08/2020

Overall trial end date

30/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Give written informed consent and receive a copy of the signed Informed Consent form
2. Be at least 18 years of age and typically use a manual toothbrush
3. Be in good general health as determined by the investigator/designee based on a review/update of their medical history
4. Have been previously qualified to participate in a plaque panel
5. Possess a minimum of 16 scorable teeth (excluding third molars) with facial and lingual scorable surfaces
6. Abstained from all oral hygiene procedures for approximately 24 hours prior to this visit and agree to follow this same restriction prior to all visits
7. Abstained from eating, drinking*, chewing gum and using tobacco for at least 4 hours prior to this visit and agree to follow these same restrictions prior to all visits. *Allowed small sips of water up until 45 minutes prior to their appointment
8. Agree not to participate in any other oral care study for the duration of this study
9. Agree to delay any elective dentistry, including dental prophylaxis, and to report any non-study dentistry received during the course of this study
10. Agree to refrain from using any non-study toothbrushes, dentifrices, mouth rinses, tooth whitening products or floss for the study duration other than their usual at-home toothbrush and toothpaste used between visits
11. Agree to maintain their same usual at-home toothbrush and toothpaste for the study duration
12. Agree to return for their scheduled visits and to follow all study procedures

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

52

Participant exclusion criteria

1. Five or more carious lesions requiring restorative treatment
2. Active treatment for periodontitis
3. Active orthodontic therapy, or removable denture prosthesis
4. Any disease or condition that could be expected to interfere with examination procedures or with the subject’s safe completion of this study (including allergies to dyes)
5. Using any antibiotics or a chlorhexidine mouth rinse any time within the 2 weeks prior to this visit

Recruitment start date

28/09/2020

Recruitment end date

02/10/2020

Locations

Countries of recruitment

Canada

Trial participating centre

All Sum Research Center Ltd.
6635 Kitimat Rd. #36 & #37
Mississauga
L5N 6J2
Canada

Sponsor information

Organisation

Procter & Gamble (United States)

Sponsor details

8700 Mason-Montgomery Road
Mason
45040
United States of America
+1 (0)513 622 1000
timm.h@pg.com

Sponsor type

Industry

Website

http://www.pg.com/en_US/

Funders

Funder type

Industry

Funder name

Procter and Gamble

Alternative name(s)

PG

Funding Body Type

unknown

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available because if the raw data is available but not analyzed appropriately by qualified experts in the area, it may lead to misinterpretation of the results. The study protocol, statistical analysis plan, and other additional documents are not intended to become available online.

Intention to publish date

31/10/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/09/2020: Trial's existence confirmed by Veritas IRB Inc.