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 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT04381403
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years and over, to ensure compliance with the study instructions
* Systemically healthy to exclude the possibility of calculus formation due to disease;
* Has at least 20 sound natural teeth including all lower anterior teeth, the main location of calculus build up;
* Having the history of previous calculus formation (at least 1.5 mm of calculus width) on the lingual surfaces of the mandibular anterior teeth after 3- 6 months of receiving a professional prophylaxis treatment, for better assessment of the toothpaste effectiveness;
* Agree to follow the study instruction: adherence to study arm, for the study timeline.
Exclusion Criteria:
* Pregnancy: pregnant women at high risk of developing gum inflammation that usually occurs during pregnancy, which could introduce bias to the study;
* any physical handicap, psychological or health conditions that might jeopardize the ability of the patient to brush his/ her teeth, these complications cause bias in the study;
* Antibiotics or anti-inflammatory drugs are taken within 1 month prior to the study, to avoid bias when assessing the gum health;
* Currently using Chlorhexidine oral products, since these products can affect biofilm and calculus formation, therefore they can introduce bias in our assessment of calculus removal by our toothpaste;
* Sensitivity to tartar-control toothpaste;
* Patients currently receiving dental treatment that would result in the removal of plaque or calculus and compromise our ability to measure calculus removed by the toothpaste;
* unable to return for evaluations/study recalls, to avoid the significant loss in the number of participants; 9) Having the diagnosis of Periodontal Screening and Recording scale (PSR) of 4, these type of patients have advanced periodontitis with a high risk of tooth loss (periodontal pockets of 6 mm and more) and could bias the treatment outcomes.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04381403
Study Brief:
Protocol Section:
NCT04381403