Dental Implant Healing in Patients Taking Tumor Necrosis Factor (TNF)-Alpha Inhibitors

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Pennsylvania
University of Pennsylvania School of Dental Medicine
RECRUITING
Philadelphia
Contact Information
Primary
Katherine France, DMD, MBE
kfrance@upenn.edu
215-746-2550
Backup
Stacey Secreto, CCRC
kfrance@upenn.edu
2157462550
Time Frame
Start Date: 2025-01-28
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Experimental: Patients taking TNF-alpha inhibitors
Adult patients (18 years of age or older) taking a TNF-alpha inhibitor as defined by the NIH and missing teeth will be recruited to receive dental implant placement according to standard of care for ideal dental restoration. Patients must have been taking a stable dose of the drug for at least 6 months and have no contra-indications to implant placement (regular tobacco use in the last year, periodontal disease, pathology in the jaw bone(s), history of head and neck radiation, history of antiresorptive or antiangiogenic agents, uncontrolled diabetes, pregnancy, other medical conditions that preclude safe delivery of outpatient medical care) to be eligible for enrollment in the study.
Experimental: Patients not taking TNF-alpha inhibitors
Patients over age 18 not taking TNF alpha inhibitors will be recruited and matched via age and sex to the patients taking TNF-alpha inhibitors. The general exclusion criteria (regular tobacco use in the last year, periodontal disease, pathology in the jaw bone(s), history of head and neck radiation, history of antiresorptive or antiangiogenic agents, uncontrolled diabetes, pregnancy, other medical conditions that preclude safe delivery of outpatient medical care) will apply to both arms equally.
Related Therapeutic Areas
Sponsors
Collaborators: Nobel Biocare
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov