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 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT03684993
Eligibility Criteria:
Inclusion Criteria:
* High caries risk patients according to CAMBRA caries risk assessment tool
* Baseline of at least 2-3 active non-cavitated or cavitated carious lesionssz
* Baseline salivary Mutans streptococci count ≥ 106 CFU/ml
* Baseline salivary Lactobacilli count ≥ 104 CFU/ml
* Baseline DMF index of at least 3-5
* Cooperative patients approving to participate in the study
Exclusion Criteria:
* Any systemic conditions, severe medical complications
* Significant past or current medical condition that may affect oral health or oral flora
* Current medications (may affect the oral flora or salivary flow)
* Allergy to any of the ingredients of the study products
* Use of any antibiotics within the past 3 months
* Use of any mouth rinses within the past 3 months
* Current periodontitis (sites of probing pocket depth ≥ 5 mm)
* Evidence of parafunctional habits
* Dysfunction of temporomandibular joint
* Presence of developmental dental anomalies
* Presence of orthodontic appliance or removable prosthesis
* Pregnancy
* Xerostomia
* Heavy smoking
* Drug or alcohol addiction, or conditions that may decrease adhering to study protocol
* Lack of compliance
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT03684993
Study Brief:
Protocol Section:
NCT03684993