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Cytokine Inhibitor

Patients taking TNF-alpha inhibitors for Dental Implants

N/A
Waitlist Available
Led By Katherine France, DMD, MBE
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Over the age of 18
* Require placement of implants to assist with dental restoration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

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.

Who is the study for?
This trial is for individuals missing teeth who are either taking TNF-alpha inhibitors, a type of biologic drug, or not on these medications. They should be seeking dental implants and willing to participate in follow-ups including x-rays and pain assessments over a year.
What is being tested?
The study aims to compare the healing process and pain levels after dental implant placement between patients using TNF-alpha inhibitors and those who aren't. It involves clinical exams, x-rays, pain diaries, and tracking medication use post-procedure.
What are the potential side effects?
Potential side effects may include complications related to implant healing such as increased pain or delayed bone integration around the implant. Specific side effects from TNF-alpha inhibitors are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety of implant placement in patients taking TNF-α inhibitors
Secondary study objectives
Patient pain after implant placement in patients receiving TNF-alpha inhibitors using analgesic use
Patient pain after implant placement in patients receiving TNF-alpha inhibitors using patient rating scales
Other study objectives
Systemic levels of inflammatory markers

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patients taking TNF-alpha inhibitorsExperimental Treatment1 Intervention
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.
Group II: Patients not taking TNF-alpha inhibitorsExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placement of dental implants
2018
N/A
~340

Find a Location

Who is running the clinical trial?

Nobel BiocareIndustry Sponsor
24 Previous Clinical Trials
2,306 Total Patients Enrolled
4 Trials studying Dental Implants
115 Patients Enrolled for Dental Implants
University of PennsylvaniaLead Sponsor
2,043 Previous Clinical Trials
42,889,597 Total Patients Enrolled
Katherine France, DMD, MBEPrincipal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
17 Total Patients Enrolled
~20 spots leftby Dec 2025
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