Dental Implant Healing With TNF-Alpha Inhibitors
NCT06538870 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-20
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 main questions it aims to answer are:
Do patients taking TNF-alpha inhibitors have any complications after the placement of dental implants? Do patients taking TNF-alpha inhibitor experience increased pain after dental implant placement compared to the expected levels when healing from this procedure? Researchers will recruit patients both taking these drugs and those not taking these drugs to compare the outcomes between the two groups.
Participants missing teeth will be recruited to receive dental implants to meet ideal dental status and will be followed before and after the implant placement to determine levels of health and ensure proper healing. Participants will be followed for a total of one year and follow up visits will consist of both clinical examination and radiographs (x-rays) to evaluate bone level and implant status. Participants will also be asked to rate their pain during clinic visits and at home on a diary and record the amount of pain control medication they take after the implant procedure.
Conditions
- Edentulism
- Dental Implants
- TNF-alpha Inhibitors
Interventions
- PROCEDURE
-
Placement of dental implants
Dental implants will be placed in the edentulous area as per standard surgical procedure and as appropriate to bring the patient to standard of care restoratively.
Sponsors & Collaborators
-
Nobel Biocare
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Katherine Theken, PharmD, PhD · University of Pennsylvania
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-06-28
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- United States
Study Locations
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