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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT01224158
Eligibility Criteria:
Inclusion Criteria:
* Males and females at least 18 years of age and in good general and oral health.
* Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.
* Willingness to use the assigned products according to instructions, availability for appointments and likelihood of completing the clinical trial.
* Good general and oral health with manual dexterity.
* Willingness to refrain from all oral hygiene procedures within 18-24 hours prior to the study visit.
* A minimum of twenty scorable teeth with at least one scorable molar in each quadrant.
* A whole-mouth mean plaque level greater than 0.60 at Day 0.
* Whole-mouth-mean gingivitis level greater than or equal to 1.75 at Day 0.
* Absence of orthodontic bands, appliances, bridges, numerous crowns, extensive large restorations, excessive caries, removable orthodontic appliances or partial dentures.
* Absence of significant oral soft tissue pathology, excluding gingivitis, based on the visual oral examination and at the discretion of the examiner.
* Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).
* Absence of moderate/advanced periodontitis.
* Absence of extensive supragingival calculus.
* Absence of ulcerations on lips and oral mucosa.
Exclusion Criteria:
* Currently taking steroids, antibiotic medication or any other medication within the previous month that may interfere with the efficacy evaluations.
* Those requiring antibiotic premedication prior to dental treatment.
* Participation in a dental clinical trial involving oral care products currently or within the past 28 days.
* Dental prophylaxis within one week prior to enrollment into the study.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
* Physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, etc.).
* Self-reported pregnant or lactating women.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01224158
Study Brief:
Protocol Section:
NCT01224158