A four week study to evaluate how well a Medical Device mouth rinse treats gingivitis compared to a medicine mouth rinse

• Register: EUCTR
• Last refreshed on: 12 December 2016
• Main ID: EUCTR2013-003548-22-GB
• Date of registration: 13/03/2014
• Prospective Registration: No
• Primary sponsor: Johnson & Johnson Consumer & Personal Products Worldwide, Division of Johnson & Johnson Consumer Companies, Inc
• Public title: A four week study to evaluate how well a Medical Device mouth rinse treats gingivitis compared to a medicine mouth rinse
• Scientific title: Four Week Clinical Efficacy of An Ethyl Lauroyl Arginate HCL (LAE) Mouth Rinse: Effect on Gingivitis
• Date of first enrolment: 03/03/2014
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003548-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United Kingdom

Contacts

• Name: Study Director
• Affiliation: Johnson & Johnson Consumer & Personal Products Worldwide, Division of Johnson & Johnson Consumer Companies, Inc

• Name: Study Director
• Affiliation: Johnson & Johnson Consumer & Personal Products Worldwide, Division of Johnson & Johnson Consumer Companies, Inc

Key inclusion & exclusion criteria

Inclusion criteria:
1.Males and females 18 years of age or older.
2.A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count.
3.A mean gingival index = 1.75 according to the Modified Gingival Index.
4.A mean plaque index = 1.95 according to the Turesky modification of the Quigley-Hein Plaque Index scored on six surfaces per tooth.
5.Bleeding Index = 0.15.
6.Absence of significant oral soft tissue pathology, excluding plaque induced gingivitis, based on a visual examination and at the discretion of the Investigator.
7.Absence of moderate/advanced periodontitis based on a clinical examination (ADA Type III, IV).
8.Absence of fixed or removable orthodontic appliance or removable partial dentures.
9.Evidence of a personally signed and dated informed consent document.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion criteria:
1.Known sensitivity to the investigational product ingredients.
2.Self-reported pregnancy or lactation.
3.Dental prophylaxis within 2 weeks prior to Screening visit.
4.History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
5.Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Gingivitis

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Intervention(s)

Trade Name: Corsodyl®Mint Mouthwash
Pharmaceutical Form: Oromucosal solution

Trade Name: LISTERINE® Advanced Defence Gum Treatment
Product Name: Listerine®Advanced Defence Gum Treatment
Pharmaceutical Form: Oromucosal solution
Pharmaceutical form of the placebo: Oromucosal solution
Route of administration of the placebo: Oromucosal use

Primary Outcome(s)

Secondary Objective: To determine the efficacy of a LAE-containing mouth rinse on wholemouth
mean modified gingival index (MGI) and plaque index (PI) scores as an adjunct to brushing through one week, two weeks and four weeks of use.
To determine the efficacy of a LAE-containing mouth rinse on whole mouth mean bleeding index (BI) score as an adjunct to brushing through one week and two weeks of use.
To determine the effect of a LAE-containing mouth rinse as an adjunct to brushing on extrinsic staining assessment at two and four weeks.

Primary end point(s): The primary efficacy variable is the whole-mouth mean Bleeding Index
(BI) at four weeks

Main Objective: To determine the efficacy of Listerine®Advanced Defence Gum Treatment (a mouthwash classified as Class IIa medical device already on the market in the EU) on whole-mouth mean gingival bleeding index (BI) scores as an adjunct to brushing through four week of use and to determine whether its performance is comparable to that of an established gingivitis treatment (i.e. Corsodyl® Mint Mouthwash).

Timepoint(s) of evaluation of this end point: Baseline and 4 weeks after treatment

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1.Whole mouth mean PI and MGI measured at one week, two weeks and four weeks.
2.BI at one and two weeks.
3.Extrinsic stain assessment at two and four weeks.

Secondary end point(s): 1.Whole mouth mean modified gingival index (MGI) and plaque index (PI)
2.Whole-mouth mean bleeding index (BI)
3.Extrinsic stain assessment at two and four weeks

Secondary ID(s)

LAEBBA0005

Source(s) of Monetary Support

Johnson & Johnson Consumer & Personal Products Worldwide, Division of Johnson & Johnson Consumer Companies, Inc