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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT00425451
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent form
* Good general health
* Male or female subjects aged \>25 years old
* Minimum of 8 natural teeth
* Availability for the 25 weeks duration of the study
* Periodontal disease on a natural teeth characterized by the presence of at least 2 teeth with periodontal pockets of 6-9 mm in depth (target teeth) in order to reach baseline (day 1) with periodontal pockets of 5-8 mm in depth, without involving the apex of the tooth.
* Females of childbearing potential must be non pregnant at entry and agree to use an adequate method of birth control during the study.
* Demonstrate bleeding on probing to the base of the pocket at the pockets (sites) selected at the time of screening.
Exclusion Criteria:
* Presence of oral local mechanical factors that could (in the opinion of the investigator) influences the outcome of the study.
* Presence of orthodontic appliances or any removable appliance that impinges on the tissues being assessed.
* Soft or hard tissue tumours of the oral cavity.
* Presence of dental implant adjacent to target tooth.
* Periodontal pockets of more than 9 mm in depth.
* General systemic antibiotics therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and through out the study duration.
* History of allergy to chlorhexidine, flurbiprofen or to other non-steroidal anti-inflammatory drugs (NSAIDs).
* Subjects taking diphenylhydantoin, nifedepine and/or cyclosporine, which might influence the pattern of tissue response.
* Subject treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and through out the study duration.
* Pregnant women or those planning to become pregnant or lactating women.
* Presence of the following conditions: Type 1 diabetes, major recurrent aphtae, stomatitis and related oral pathologies.
* The presence of any medical or psychiatric condition or any other condition that in the opinion of the investigator could affect the successful participation of the subject in the study.
* Subject participates in any other clinical study 30 days prior to the start of the study and through out the study duration.
* Subject uses chlorhexidine oral rinses/ mouthwashes on a regular basis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Study:
NCT00425451
Study Brief:
Protocol Section:
NCT00425451