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Enrolling By Invitation
NCT07732647
Immediate Implant Provisionalization
Conditions: Gum Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 44
Sponsor: University of Michigan
Location: University of Michigan School of Dentistry Ann Arbor Michigan
Summary
This research is studying gum tissue stability of dental implants placed at same appointment as the tooth extraction, with or without a provisional (temporary) crown.
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years
* Physical status according to the American Society of Anesthesiology (ASA) I or II, which include patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
* Periodontally healthy or with treated periodontitis with good oral hygiene ((FMPS) and (FMBS) ≤15%, measured at four sites per tooth).
* Presence of one non-restorable maxillary anterior tooth (from #5 to #12 sites)
* More than 20 occluding teeth with stable occlusion.
* Nonsmokers or smokers \< 10 cig/day (self-reported).
Exclusion Criteria:
* Presence of uncontrolled or untreated periodontal disease.
* Presence of active periapical infection.
* Subjects taking medications known to modify bone metabolism or those that can interfere with the normal wound healing (such as bisphosphonates, corticosteroids, hormone replacement therapy, parathyroid hormone, denosumab, strontium ranelate, etc.), or those with uncontrolled systemic diseases or conditions that may similarly affect the patient's healing (osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, uncontrolled diabetes (HBA1c \> 8)).
* Pregnant subjects or individuals attempting to get pregnant (self-reported)
* Subjects smoking 10 or more cigarettes a day, or those with a history of drug or alcohol abuse (self-reported)
* Subjects unable to maintain adequate oral hygiene
* Insufficient restorative space or bite collapse.
* Lack of primary implant stability assessed intrasurgically.
Source: ClinicalTrials.gov (NCT07732647). StuddyBuddy aggregates publicly available trial information.