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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT03354312
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent must be available
* Willingness and ability to comply with scheduled visits, treatment plan, and other study procedures
* Patient systemically healthy except for controlled diabetes and hypertension
* Patients with comparable periodontal status of the right and left jaw, with ≥ 3 teeth with pockets ≥ 4 mm and ≤ 7 mm per quadrant
* Female patients of childbearing potential must practice highly effective contraception methods
Exclusion Criteria:
* Generalized severe periodontitis with pockets \> 8 mm
* More than 2 pockets \> 7 mm and ≤ 8 mm per quadrant
* Contraindicated for treatment with the investigational product, the comparator drug, or meet warnings and precautions for use specifications in accordance with the approved SmPCs as follows:
* Hypersensitivity to the investigational product, the comparator drug or to any of their respective excipients
* Hypersensitivity to other local anesthetics of the amide type
* Severe uncontrolled and untreated excitation and conduction disorder of the heart
* Acute decompensated heart failure
* Severe renal or hepatic disease/dysfunction
* Untreated or uncontrolled diabetes type 2
* Severe hypertension and severe hypotension
* Narrow-angle glaucoma
* Hyperthyroidism
* Paroxysmal tachycardia or high-frequency absolute arrhythmia
* Myocardial infarction within the last 6 months
* Coronary artery bypass within the last 3 months
* Concurrent use of non-cardio selective beta blockers (e.g. propranolol)
* Pheochromocytoma
* Concurrent treatment with tri-cyclic antidepressants or monoamine oxidase (MAO) inhibitors
* Use of painkillers or anti-inflammatory drugs 24 hours before the first treatment
* Antibiotic prophylaxis or treatment with antibiotics
* Use of any anxiolytic medication
* Periodontal treatment within the last 3 months
* Continuing orthodontic treatment
* Concurrent use of another investigational medication
* Participation in another clinical trial within the last 3 months
* Women who are pregnant or breastfeeding, or planning pregnancy while enrolled in the study
* Persons who are in a dependency or working relationship with the sponsor or investigator
* A subject who, in the opinion of the investigator will be uncooperative or unable to comply with study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03354312
Study Brief:
Protocol Section:
NCT03354312