Status:
RECRUITING
Dental Implant Healing With TNF-Alpha Inhibitors
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Nobel Biocare
Conditions:
Edentulism
Dental Implants
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this pilot study is to learn about healing after dental implant placement in patients taking a class of biologic drug called Tumor Necrosis Factor or TNF-alpha antagonist or inhibitor. The...
Detailed Description
This descriptive study will recruit 15 patients requiring implant restoration as standard of care for missing teeth taking a stable dose (unchanged for 6 months or more) of a TNF-α inhibitor, regardle...
Eligibility Criteria
Inclusion
- Over the age of 18
- Require placement of implants to assist with dental restoration.
- Half of the patients (15) will be recruited with the key criteria of a TNF-alpha inhibitor medication that they have been taking consistently without dose adjustment or other changes for at least 6 months. The other half will be recruited without a target medical condition but will be recruited to match the patients taking TNF-alpha inhibitors in age and gender.
- All patients will be medically fit to withstand implant placement as judged by best practice applied by the study team.
- The patients will be required to read and speak English
- All patients must either provide their own independent consent for medical procedures or to attend study visits with a surrogate decision maker.
Exclusion
- Patients will not be excluded on the basis of age (within the adult population), race, economic status, sex or gender, or other demographic factors. Patients will be excluded if:
- They have periodontal disease (periodontal pockets above 4mm in the applicable arch or radiographic evidence of horizontal bone loss more than mild severity)
- There is other evidence of pathology in the treated arch on pre-treatment review including radiographs, such as any evidence of cyst or tumor formation in the mandible.
- They have uncontrolled diabetes (HbA1c \>8.0) as confirmed by evaluating labs taken on anyone with diagnosed diabetes in the 6 months before the study enrollment.
- They have history of head and neck radiation for any reason
- They are taking any antiresorptive or antiangiogenic agents for any reason including osteoporosis, multiple myeloma, bone metastasis of other primary cancers
- They are unable to seek outpatient medical care or are not medically fit to withstand implant placement, including those with critical findings or lab values. Medical exclusion of patients will be completed by the investigators based on standard of care for surgical procedures in dental medicine and based on specific implant guidelines.
- Patients who have routinely used tobacco or tobacco products in the last 1 year will be excluded, as tobacco use is a known contributor to poor prognosis after implant placement. For this reason, dental implant placement is only recommended in patients who have quit or never used tobacco products.
- Pregnant women are unlikely to meet inclusion criteria as dental implant placement is considered an elective procedure and typically deferred in dentistry until after delivery.
Key Trial Info
Start Date :
June 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06538870
Start Date
June 28 2025
End Date
December 1 2026
Last Update
January 7 2026
Active Locations (1)
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1
University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, United States, 19104