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 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT03243032
Eligibility Criteria:
Inclusion Criteria:
* Adult patients 18 years of age and under 65 years of age
* ASA Type I \& II
* Single tooth edentulous site requiring dental implant placement without any additional bone or soft tissue augmentation at the time of implant placement
* Patients not requiring use of any form of sedation for dental implant surgery (nitrous, oral or IV sedation)
Exclusion Criteria:
* Hypersensitivity to NSAIDs, salicylates, or microcrystalline cellulose NF (Avicel PH 105)
* Liver disease
* Renal disease
* Hypertension and taking angiotensin-converting-enzyme inhibitors and/or diuretics
* Significant respiratory conditions including acute or severe asthma.
* Cardiovascular disease that will prevent the patient from going through the surgical procedure or consuming the required medications: cardiac disease, cardiomyopathy, cardiac arrhythmias, coronary heart disease, acute MI, angina, history of MI, coronary artery bypass grafting (CABG), Aspirin intake, peripheral vascular disease, cerebral vascular disease (stroke, TIA)
* Gastrointestinal disease including irritable bowel disease and gastric ulcers
* Hematological diseases (coagulopathy, hemophilia or thrombocytopenia)
* Pregnancy/lactation at the time of surgery
* Heavy smoking (\>10 cigarettes per day)
* Diabetes
* Allergies or intolerance to ibuprofen, opioids, and local anesthetic (lidocaine and bupivacaine)
* History of recreational drug abuse
* History of heavy alcohol use. Substance Abuse and Mental Health Services Administration (SAMSHA)30 defines heavy alcohol use as binge drinking on 5 or more days in the past month. SAMSHA defines binge drinking as 5 or more alcoholic drinks for males or 4 or more alcoholic drinks for females on the same occasion (i.e., at the same time or within a couple of hours of each other) on at least 1 day in the past month.
* Patients currently taking prescription pain medications or have taken over-the-counter pain medications within 4 days of surgery.
* Patients with drug-drug or drug-disease state interactions
* Other significant medical conditions (not reported above) that are likely to prevent the patient from going through the surgical procedure or consuming the required medications.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT03243032
Study Brief:
Protocol Section:
NCT03243032