Condition category
Oral Health
Date applied
21/01/2019
Date assigned
23/01/2019
Last edited
23/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Periodontal (gum) disease is prevalent worldwide. The critical strategy is prevention through effective daily oral hygiene and early diagnosis and treatment before further progression occurs. Since oral (mouth) fluids and dental plaque samples are easy to collect in everyday dental practice and because they contain biomarkers of gingivitis (gum inflammation), these samples may provide a good basis for a specific and improved early periodontal diagnostic tool. The aim of this study is to investigate whether the use of an electric toothbrush and an irrigator over a period of 8 weeks is able to reduce gingivitis and plaque and improve oral fluid/pathogen biomarker levels reflecting better gingival health.

Who could participate?
Generally healthy adults with evidence of mild to moderate gingivitis

What did the study involve?
Participants are randomly allocated to either the test group (electric toothbrush and irrigator) or the control group (regular manual toothbrush). Participants use their assigned products with a regular toothpaste twice daily at home for the duration of the study. At the beginning of the study and at weeks 2, 4, and 8 dental plaque and gingivitis status are evaluated by a dentist. Also saliva and fluids from the gingival pockets are collected for biomarker analysis. Additionally, home saliva samples are collected by the participants before all clinical visits for analysis.

What were the possible benefits and risks of participating?
The study was designed to assess if the participants in the test group experience an improvement in oral health. The participants received information by dental professionals about their oral health status and weaknesses in their oral hygiene routine. In addition, their participation helped in the development of products that aim to improve oral health. Both groups received a dental prophylaxis (cleaning procedure) at their final visit. There were no notable risks involved with participating.

Where was the study run from?
University of Bern (Switzerland)

When was the study starting and how long was it expected to run for?
November 2010 to July 2013

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

Who is the main contact?
Dr Christoph Ramseier

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christoph Ramseier

ORCID ID

Contact details

Department of Periodontology
School of Dental Medicine
University of Bern
Freiburgstrasse 7
Bern
3010
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Clinical Protocol 2010009

Study information

Scientific title

Clinical parameters and oral fluid biomarkers in gingivitis subjects using a powered toothbrush with irrigator or a manual toothbrush alone: an 8-week randomized controlled clinical trial

Acronym

Study hypothesis

The objective of the research is to investigate whether 8 weeks use of an improved homecare oral hygiene regimen that includes combination of an electric toothbrush and an irrigator will result in better gingival health (measurement of gingival index (GI) by Löe & Sillness (1963)) compared to a standard homecare oral hygiene regimen.

This study will secondarily evaluate the ability to distinguish the levels of gingivitis-associated oral fluid biomarkers and dental plaque between the two treatment groups.

Ethics approval

Kantonale Ethikkommission Bern, Postfach 56, Murtenstrasse 31, 3010 Bern, Switzerland, Tel: 0041 31 632 86 33, Email: pfiffner@kek-unibe.ch, 08/10/2012, IRB Approval #: KEK 066/11

Study design

Single-center randomized controlled examiner-blind two-treatment parallel study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

Oral mild to moderate gingivitis

Intervention

Participants were stratified at baseline on age, tobacco use, number of bleeding sites, and mean plaque index. Within these strata, participants were randomly assigned to either the Test group (electrical toothbrush/irrigator and a standard anti-cavity toothpaste) or the Control group (regular manual toothbrush and a standard anti-cavity toothpaste).

Participants were instructed to use the study products at home twice daily (morning and evening) in place of their normal oral hygiene for the duration of the study (8 weeks). Participants were asked to refrain from flossing for the duration of the study.

Participants of the Test group were instructed to brush their teeth using the toothpaste and electrical brush according to manufacturer instructions. They were instructed to rinse their mouth with water after brushing to remove excess paste. Then Participants should rinse their mouth with the irrigator with 300 ml water for approximately 1 minute.

Participants of the Control group were instructed to brush their teeth as they normally do using the products provided. Participants were instructed to rinse their mouth with water after brushing to remove excess paste.

At baseline and at week 2, 4, and 8 plaque and gingivitis were evaluated and gingival crevicular fluid (GCF) and whole saliva (WS) were collected for biomarker analysis. Additionally, home saliva samples were collected by the participants prior to all clinical visits for metabonomics and biomarker analysis on 5 consecutive days (one sample per day).

Intervention type

Other

Phase

Drug names

Primary outcome measure

Gingival inflammation and bleeding measured by Gingival Index (Löe & Sillness 1963) at baseline, week 2, 4, and 8

Secondary outcome measures

Measured at baseline, week 2, 4, and 8:
1. Gingivitis-associated oral fluid biomarkers: whole Saliva and GCF (both collected at the clinic) were quantitatively analyzed for the amount of matrix-metalloproteinase (MMP)-8 and interleukin (IL)-1β by means of ELISA technique
2. Dental plaque measured by Plaque Index (Silness-Löe 1964)

Overall trial start date

08/11/2010

Overall trial end date

10/07/2013

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Be at least 18 years of age
2. Provide written informed consent prior to participation and be given a signed copy of the informed consent form
3. Be in good general health as determined by the Investigator/designee based on a review of the medical history/update for participation in the study
4. Agree to return for the scheduled clinical visits and follow study instructions
5. Agree not to participate in any other oral care study for the duration of this study
6. Agree not to use any non-study oral hygiene products for the duration of the study (including dental floss)
7. Agree to delay any elective dentistry, including dental prophylaxis (outside of the study protocol), until study completion
8. Agree to refrain from brushing their teeth and from performing any other oral hygiene procedures 12 hours prior to each visit
9. Agree to refrain from eating, chewing gum, drinking or using tobacco for 4 hours prior to each visit
10. Have at least 20 gradable teeth
11. Have at least 15 gingival bleeding sites (as described in section 13 - Löe & Silness GI)

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
2. Active treatment for periodontitis
3. Fixed facial or lingual orthodontic appliances
4. Regular use of electric toothbrush
5. Need of antibiotic prophylaxis prior to the dental visit
6. Antibiotic use or prescription mouth rinse use within one month prior of Screening (Visit 1)
7. Dental prophylaxis within one month prior of Screening (Visit 1)
8. Any disease or condition that could be expected to interfere with the subject safely completing the study
9. Pregnancy or lactation

Recruitment start date

11/02/2013

Recruitment end date

10/05/2013

Locations

Countries of recruitment

Switzerland

Trial participating centre

University of Bern, Department of Periodontology, School of Dental Medicine
Freiburgstrasse 7
Bern
3010
Switzerland

Sponsor information

Organisation

Procter and Gamble Company

Sponsor details

8700 Mason-Montgomery Road
Mason Ohio
45040
United States of America

Sponsor type

Industry

Website

https://us.pg.com

Funders

Funder type

Industry

Funder name

Procter and Gamble

Alternative name(s)

Procter & Gamble, PandG, P&G

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Study protocol, statistical analysis plan, and other additional documents are not intended to become available online. Planned publication of the study results 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.

Intention to publish date

31/12/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes