E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gingival bleeding and gingivitis |
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E.1.1.1 | Medical condition in easily understood language |
Gum bleeding and gum inflammation |
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E.1.1.2 | Therapeutic area | Diseases [C] - Mouth and tooth diseases [C07] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018292 |
E.1.2 | Term | Gingivitis |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018276 |
E.1.2 | Term | Gingival bleeding |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate and compare Gingival Bleeding (as assessed by the gingival severity component of the Gingival Index [GI]) following twice daily use of a non-alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only. Also twice daily use of an alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only. |
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E.2.2 | Secondary objectives of the trial |
To evaluate and compare Gingivitis (as assessed by the Gingival Index) following twice daily use of a non-alcohol 0.2% Chlorhexidine (CHX) mouthrinse and brushing compared to brushing only. Also twice daily use of an alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only.
To evaluate and compare plaque control (overall and interproximal dental plaque scores) using Turesky modification of Quigley & Hein plaque index following twice daily use of a non-alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only. Also twice daily use of an alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 at least 18 years and not over 64 years.
3. Compliance
Understands and is willing, able and likely to comply with all study procedures and restrictions.
4. General Health
Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/ dental examination.
5. Dental Health
a) Good oral health in the opinion of the investigator (allowing mild to moderate gingivitis to meet entry criteria).
b) A minimum of 20 permanent gradable teeth at screening. (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded).
c) Mild to moderate gingivitis present at the screening visit in the opinion of the investigator.
d) Positive response to bleeding on brushing exercise at screening visit.
e) A total of 20 bleeding sites or greater at baseline visit.
6. Contraception
Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. 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. |
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E.4 | Principal exclusion criteria |
1. Pregnancy
Women who are pregnant, intending to become pregnant or who have a positive urine pregnancy test at the screening, baseline or prophylaxis visits.
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. Medical History/ Current Medications
a) Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the subject unlikely to fully complete the study or any that increases the risk to the subject or undermines the data validity.
b) Subjects requiring prophylactic antibiotic treatment prior to dental therapy.
c) Use of concomitant medication that, in the opinion of the investigator, might interfere with the outcome of the study or increases the risk to the subject (eg: phenytoin, calcium antagonists, cyclosporine, warfarin, antibiotics, immuno-suppressants).
d) Use of antibiotics within two weeks prior to the screening visit or throughout the study.
e) Use of any systemic medication which would have an effect on gingival conditions within 14 days of gingival examinations (eg: ibuprofen or aspirin therapy)
6. Dental Health
a) Have current active caries
b) More than 3 pockets with 5mm or over.
c) Excessive calculus present that interferes with the probing examination for Gingival Index.
d) Other severe oral/ gingival conditions (e.g. Acute Necrotizing Ulcerative Gingivitis) that may compromise the study or the subjects in the opinion of the investigator or gingivitis examiner.
e) Medical conditions which may directly influence gingival bleeding.
f) Restorations in a poor state of repair.
g) Orthodontic appliances anterior cosmetic restorations and veneers.
h) Enamel pitting/irregularities.
7. Tobacco Chewers
Subjects using chewing tobacco, pan, pan-masala, gutkha or other chewing tobacco products or subjects who have quit using any of those within the past six months prior to screening.
8. Substance abuse
Recent history (within the last year) of alcohol or other substance abuse.
9. Personnel
a) An employee of the sponsor or the study site or members or their immediate family.
b) An employee of any toothpaste manufacturer or their immediate family. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Gingival Severity Index (a component of the Gingival Index assessing the proportion of bleeding sites) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
-Gingival index score
- Overall plaque score (Turesky Modification of the Quigley Hein Index)
- Interproximal plaque score (Turesky Modification of the Quigley Hein Index) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Toothbrushing with a sodium fluoride toothpaste |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS plus 5 days for follow up of adverse events |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 70 |