Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT01962493
Eligibility Criteria:
Inclusion Criteria:
* Good oral health in the opinion of the investigator (excluding gingivitis)
* A minimum of 11 of the 12 permanent gradable anterior teeth at screening
* 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
* 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 facial surfaces of anterior teeth.
Exclusion Criteria:
* Pregnant women or women who are intending to become pregnant over the duration of the study
* Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds).
* Current use of Chlorhexidine, Cetylpyridinium Chloride or any marketed mouthwash
* Past or current use of any drug which is known to be associated with tooth discolouration within 30 days of screening or during the study period.
* Recent history (within the last 1 year) of alcohol or other substance abuse
* Dental conditions / disease requiring immediate treatment; Crowns or veneers on more than one anterior tooth; pre-existing sensitivity to oral care products; severe periodontitis; severe recession; dental implants; active carious lesions on anterior teeth; oral lesions/manifestations; prone to aphthous stomatitis and ulceration etc.
* Participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study.
* Medical condition which would require the use of prophylactic antibiotics prior to dental cleanings
* Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01962493
Study Brief:
Protocol Section:
NCT01962493