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:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT00762450
Eligibility Criteria:
Inclusion Criteria:
* Maxillary dentition is preferentially natural.
* Maxillary restorations and/or reconstructions and eventual partial dentures must be in clinically good condition.
* Natural mandibular front teeth and first premolars (4-4) are retained.
* Second mandibular molars are ideally present to serve as abutment teeth.
* Mandibular restorations and/or reconstructions must be in clinically good condition.
* Partial mandibular denture replacing second premolars and first (and second) molars in good clinical condition.
* Subjects should have a stimulated saliva flow rate of 1-2 ml/min (by chewing paraffin wax).
* Willingness to give their informed consent and comply with the protocol.
* No history of allergy to personal/oral care consumer products or ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
Exclusion Criteria:
* Current participation in other dental clinical trials.
* Subjects who are unable to provide sufficient plaque growth over a 2-day non- brushing period (by visual assessment).
* Subjects in whom the plaque pH fails to fall sufficiently, i.e. at least to pH 5 following a sucrose rinse.
* Subjects with poor oral health, i.e. with advanced periodontitis, un-restored carious lesions and stomatological diseases.
* Subjects taking drugs known to currently affect salivary flow.
* Subjects with un-stimulated salivary flow \<0.3 ml/min and/or stimulated flow \<0.9 ml/min.
* Women who are pregnant or breastfeeding
* History of allergy to common dentifrice ingredients
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
* Women of child bearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (intrauterine device) or condoms)
* Medical condition which requires premedication prior to dental procedures/visits
* History of allergy to amino acids
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
72 Years
Maximum Age:
79 Years
Study:
NCT00762450
Study Brief:
Protocol Section:
NCT00762450