Phase
Condition
Periodontitis
Treatment
TSX
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients at least 18 years of age
Patients for whom a decision has already been made to use a dental implant in anedentulous or immediately removed tooth site to be fully restored in the mandible ormaxilla.
Site planned for immediate extraction and immediate restoration should have intactbony walls- Type I (as described in Special Procedures section) sockets as verifiedby CBCT and during surgery; Type II may be considered at the discretion of thetreating clinician
Previously extracted sites (healed at least 3-4 months)
For all sites, presence of opposing dentition (antagonist may be natural teeth orimplant supported prosthesis) that will allow for functional occlusion is essential.
The site intended for implant placement should have at least 10mm of alveolar boneheight and sufficient restorative space for a restoration; without the need foraugmentation except for minor dehiscence, which can be augmented with autogenousbone chips and/or allograft (i.e.: Puros) to improve soft tissue attachment.
Patients must be physically able to tolerate conventional surgical and restorativeprocedures (IV sedation protocols may be used at the discretion of the treatingclinician).
Patients who provide a signed informed consent.
Patients who agree to be evaluated for each study visit.
Exclusion
Exclusion Criteria:
Patients with known systemic diseases such as diabetes, endocrine disease, heartdisease, immuno-compromised, or mental disorders that are uncontrolled at the timeof enrollment.
Patients with current use of bisphosphonates.
Patients with active infection or severe inflammation in the areas intended fortreatment.
Patients with more than10 cigarette per day smoking habit.
Patients with a history of therapeutic radiation to the head or jaw.
Patients who are known to be pregnant at the screening visit or planning to becomepregnant within 6 months of study enrollment.
Patients with evidence of untreated severe parafunctional habits such as bruxing orclenching.
Patients who have previously failed dental implants at the site intended for studyimplant placement
Patients with HIV or active Hepatitis infection.
Patients with a history of untreated generalized severe periodontitis.
Study Design
Study Description
Connect with a study center
Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
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