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 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT04640857
Eligibility Criteria:
Inclusion Criteria:
* Male or female patient aged 20-85 Years old
* Subject must have voluntarily signed the informed consent form before any study related action
* Presence of gingival inflammation (Gingival Index by Silness and Loe 1969)
* Presence of plaque on clinical crowns (calculation of area)
* Supportive periodontal therapy (with ultra-sonic and manual devices) on a regular basis with a 3-month interval with a minimum of 3 times in a row prior to T0 (baseline)
* Compliance with study schedules and arrival at study visits
Exclusion Criteria:
* A systemic or pharmacological condition that can affect the healing of soft or hard tissue in the rest of the teeth or implants such as cyclosporine, calcium channel blockers
* Pregnant or lactating women (\*If Male Please write N/A).
* Heavy smokers (more than 10 cigarettes per day).
* Patients with a pacemaker that do not allow the use of an ultrasonic device.
* Patient with an active periodontal disease (may undergo periodontal treatment as required and not completed as part of the study if it can be included in the study).
* Systemic condition requiring prophylactic antibiotics.
* Patients taking NSAIDS for prolonged period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT04640857
Study Brief:
Protocol Section:
NCT04640857