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 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT06158633
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years of age
* Enrollment in the homecare COPD/CHF program or who possibly have other medical conditions such as on dialysis or chronic metabolic condition (e.g. diabetes, hypertension) suitable for entry into the home care program
* Bleeding on probing at ≥ 12 sites at Screening
* Minimum of 10 natural teeth
* Willing and able to provide informed consent as per International Conference on Harmonization - Good Clinical Practices Guidelines (ICH-GCP E6(R2)) and applicable regulations.
Exclusion Criteria:
* Currently smoking one or more cigarettes per day
* Patients with a prosthetic heart valve
* Active visual caries which, in the judgement of the investigators, could require surgical restoration or extraction, and referral to a dentist on an urgent basis
* Severe periodontal disease which, in the judgement of the investigators, could require surgery or a level of periodontal scaling such that participation in the study will be delayed
* Undergoing periodontal care by a dentist or hygienist which in the judgement of the investigators could confound the study results
* Known allergies to the ingredients of the study medications (chlorhexidine, Sumatra benzoin, ethanol and polymethylmethacrylate)
* Taking medications for periodontal conditions (e.g., Periostat, chlorhexidine rinse, PerioChip or Arestin).
* Uncontrolled seizure disorder
* A gag reflex
* Cancer that is in an active stage of treatment or has been treated with chemotherapy and/or radiation in the past year or in the next 12 months
* Behavioural disorders which in the judgement of the investigators threaten the patient's tolerance to treatment and participation in the study
* Involved in another drug trial
* Not able to complete subject reported, self-administered questionnaires or not able have a caregiver complete these questionnaires, or cannot fully understand all instructions in English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06158633
Study Brief:
Protocol Section:
NCT06158633