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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT02319668
Eligibility Criteria:
Inclusion Criteria:
* Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
* Aged between 18-64 years old.
* Understands and is willing, able and likely to comply with all study procedures and restrictions
* Good general and mental health with, in the opinion of the investigator or medically qualified designee:
1. No clinically significant and relevant abnormalities in medical history or upon oral examination.
2. Absence of any condition that could affect the participant's safety or well being or their ability to understand and follow study procedures and requirements.
* Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception
* Dental Health
1. Good overall oral health in the opinion of investigator.
2. A minimum of 20 permanent teeth.
3. Requiring a single and simple implant (single tooth replacement with no bone augmentation required for implant placement).
* Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.
Exclusion Criteria:
* Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
* Women who are breast-feeding
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
* Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
* Previous participation in this study
* Recent history (within the last 1 year) of alcohol or other substance abuse
* Use of antibiotics within 14 days prior to the Baseline visit or Implant surgery visit.
* An employee of the sponsor or the study site or members of their immediate family
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02319668
Study Brief:
Protocol Section:
NCT02319668