A study to evaluate the effect of a 67% Sodium Bicarbonate containing toothpaste on Chlorhexidine Digluconate tooth staining

• Conditions: Tooth discolouration (a labelled undesirable effect of Corsodyl 0.2% mouthwash); MedDRA version: 14.1Level: PTClassification code 10044032Term: Tooth discolourationSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 14.1Level: PTClassification code 10018292Term: GingivitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2013-002418-11-GB
• Lead Sponsor: GlaxoSmithKline Consumer Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-14
• Last Update Posted: 17 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Consent

Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.

2. Age

Aged 18 – 64 years inclusive.

3. Compliance

Understands and is willing, able and likely to comply with all study procedures and restrictions.

4. General Health

Good general and mental health with, in the opinion of the investigator or medically qualified designee:

a) No clinically significant and relevant abnormalities of medical history or oral examination.
b) Absence of any condition that would impact on the subject’s safety or wellbeing or affect the individual’s ability to understand and follow study procedures and requirements.

5. Contraception

Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception, for at least three months prior to the start of the study and must not be breast feeding. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) OR male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject.

6. Oral Health

a) Good oral health in the opinion of the investigator (excluding gingivitis)
b) A minimum of 11 of the 12 permanent gradable anterior teeth at screening. (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded).
c) A total of at least 15 bleeding sites or greater at screening visit.
d) Stain levels on the buccal surfaces of the 6 maxillary and 6 mandibular anterior teeth need to be at least mild” and present on a minimum of 4 teeth (out of the 12 maxillary and mandibular teeth evaluated), as confirmed by gross stain assessment.

7. Modification of the Lobene Stain Index

At Visit 2, a baseline total MLSI Intensity x Area score (four sites per tooth) of greater than or equal to 8 for the facial surfaces (gingival/body/mesial/distal) of anterior teeth numbers 6-11 and facial surfaces of teeth numbers 22-27.

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 160
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnancy

Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.

2. Breast-feeding

Women who are breast–feeding.

3. Allergy/Intolerance

Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds) or any of their stated ingredients.

4. Clinical Study/Experimental Medication

a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
b) Previous participation in this study.

5. Medication

a) Current use of a Chlorhexidine, Cetylpyridinium Chloride (CPC) or Listerine® Original mouthwash.

b) Past or current use of minocycline, and use of tetracycline or doxycycline or any other drug which is known to be associated with tooth discolouration within 30 days of screening or during the study period.

6. Substance abuse

a) Recent history (within the last 1 year) of alcohol or other substance abuse.
b) Subject unwilling to abstain from using chewing tobacco.

7. Dental History

a) Less than eleven gradable anterior teeth due to surface irregularities, restoration on the facial surfaces, tetracycline stain, discoloration due to trauma, mottling, fluorosis, hyperplasia; hypoplasia or other parameters which make it difficult to measure the extrinsic stain of the teeth consistently.
b) Partial dentures abutted to those teeth to be graded, fixed retainers, fixed or removable orthodontic appliances.
c) Dental conditions / disease requiring immediate treatment.
d) Crowns or veneers on more than one anterior tooth.
e) Pre-existing sensitivity to oral care products.
f) Severe periodontitis.
g) Severe recession.
h) Dental implants.
i) Obvious active carious lesions on anterior teeth.
j) Intra-oral decorative tattoos, or tongue and or lip piercing.
k) Oral lesions/manifestations that would impact on the subject’s inclusion in the study (lichen planus/ large bands of keratinized tissue).
l) Prone to aphthous stomatitis and ulceration (self-reported history of more than 6 months).
m) Presence of oral or peri-oral ulceration including herpetic lesions at the time of screening or at baseline.

8. Condition of Oral Mucosa

Subjects with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g. current oral ulceration).

9. Medical Conditions

a) Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the subject unlikely to fully complete the study or any condition that presents undue risk from the study treatment or procedures in the opinion of the investigator or dental assessor.
b) Medical condition which would require the use of prophylactic antibiotics prior to dental cleanings.
C) Subject currently undergoing radiotherapy and/or chemotherapy treatment.

10. Personnel

a) An employee of the sponsor or the study site or members of their immediate family.
b) Subject works in one of the following: advertising, journalism, public relations, manufacturing, retail or distribution of medicines, medical devices or healthcare products, market research or marketing.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified