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Cytokine Inhibitor

Dental Implants for Patients Using TNF-Alpha Inhibitors

N/A

Recruiting

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

Patients must be able to read and speak English

Patients requiring placement of implants to assist with dental restoration

Must not have

Evidence of pathology in the treated arch on pre-treatment review including evidence of cyst or tumor formation in the mandible

Taking antiresorptive or antiangiogenic agents for any reason

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if patients taking a certain type of medication called TNF-alpha inhibitors have any issues or increased pain after getting dental implants. They will compare patients taking these drugs to those not taking

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

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I can read and speak English.

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I need implants for dental restoration.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My dental scans show a cyst or tumor in my jaw.

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I am currently taking medication to prevent bone loss or to stop the formation of new blood vessels.

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I have severe gum disease with deep pockets or significant bone loss.

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I have had radiation therapy to my head or neck.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met