Dental Implant Healing With TNF-Alpha Inhibitors
NCT Number: NCT06538870
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Edentulism|Dental Implants|TNF-alpha Inhibitors
Interventions: PROCEDURE: Placement of dental implants
Sponsor: University of Pennsylvania
Collaborators: Nobel Biocare
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12
Locations: University of Pennsylvania School of Dental Medicine, Philadelphia, Pennsylvania, 19104, United States

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.

Primary Outcome Measures: Safety of implant placement in patients taking TNF-α inhibitors, A pilot cohort of patients will be recruited who require implants for standard of care restoration for tooth loss. Patients will be evaluated pre- and post-operatively and followed for 1 year to assess healing using clinical exam., Healing will be assessed over 1 year after implant placement
Secondary Outcome Measures: Patient pain after implant placement in patients receiving TNF-alpha inhibitors using patient rating scales, While no previous dental research has directly evaluated perception of healing in patients taking TNF-α inhibitors, previous evidence points to an increase in pain during surgical healing in patients taking BAs. Patient discomfort will be measured by visual analog (VAS) patient rating scales as are widely used after dental surgery. The VAS scale from 0 to 10 where 0 means no pain and 10 means the worst possible pain will be used.

Applying these outcomes to implant healing in patients taking TNF-α inhibitors will provide an assessment of patient experience. We hypothesize that there will be an increase in pain ratings compared to established expectations. This is the first study to evaluate patient discomfort after implant placement in patients taking BAs and the first prospective study of patients taking BAs in dental medicine and thus will add to the literature by characterizing healing and patient experience., This will be assessed during the pre-surgical appointment to understand patient baseline and after surgery daily for the first week and then at 1 week, 1,3,6,and 12 months.|Patient pain after implant placement in patients receiving TNF-alpha inhibitors using analgesic use, While no previous dental research has directly evaluated perception of healing in patients taking TNF-α inhibitors, previous evidence points to an increase in pain during surgical healing in patients taking BAs. Patient discomfort as measured by analgesic use in number and timing of doses taken will be evaluated. Extrapolating these outcomes to implant healing in patients taking TNF-α inhibitors will provide an assessment of patient experience. We hypothesize that there will be an increase in analgesic need compared to established expectations, to be further evaluated according to additional factors, if present, at further study. This is the first study to evaluate patient discomfort after implant placement in patients taking BAs and the first prospective study of patients taking BAs in dental medicine and thus will add to the literature by characterizing healing and patient experience., This will be assessed during the pre-surgical appointment to understand patient baseline and after surgery daily for the first week and then at 1 week, 1,3,6,and 12 months.
Other Outcome Measures: Systemic levels of inflammatory markers, We will also perform exploratory analyses of whether systemic inflammation, as assessed by systemic blood markers (CRP, ESR, CBC, and cytokine measurements), is associated with implant healing, peri-implantitis, or discomfort after implant placement., Blood will be drawn for lab tests at implant visit and at follow up visits (1 week, 1 month, 3 month, 6 month, 12 month) to trend values.