Dental Implant Healing with TNF-alpha Inhibitors

This study is looking at how dental implants heal in people who are taking certain medications called TNF-alpha inhibitors. These medications are used to treat various conditions. Researchers want to see if taking TNF-alpha inhibitors causes any problems or increased pain after dental implant surgery. They will compare 15 patients who are taking these medications with 15 patients who are not, all of whom need dental implants for missing teeth. The main goal is to understand the safety of placing dental implants in patients using TNF-alpha inhibitors, by observing their healing for one year after the implant is placed. You would not stop your TNF-alpha inhibitor medication if you participate.

Study design: This is an interventional study that plans to enroll 30 participants. It will compare outcomes between two groups of 15 participants each.
What's involved: You would have dental implants placed and then be followed for 12 months after the procedure. Your medical history, demographics, and clinical features would be evaluated.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 12 months after dental implant placement to assess healing.

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Dental Implant Healing With TNF-Alpha Inhibitors

Recruiting

NAAges 18+InterventionalTreatment

University of Pennsylvania

~30 participants

Updated 2026-05-20 on ClinicalTrials.gov

What's tested:Placement of dental implants

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Safety of implant placement in patients taking TNF-α inhibitors

Measured over Healing will be assessed over 1 year after implant placement

Conditions

Edentulism

Dental Implants

TNF-alpha Inhibitors

Where it's being run

1 sites across 1 states

Pennsylvania1

Study leadership

Katherine Theken, PharmD, PhD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

Stacey Secreto

[email protected]

215-746-8871

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

They have periodontal disease (periodontal pockets above 4mm in the applicable arch or radiographic evidence of horizontal bone loss more than mild severity)

There is other evidence of pathology in the treated arch on pre-treatment review including radiographs, such as any evidence of cyst or tumor formation in the mandible.

They have uncontrolled diabetes (HbA1c \>8.0) as confirmed by evaluating labs taken on anyone with diagnosed diabetes in the 6 months before the study enrollment.

They have history of head and neck radiation for any reason

They are taking any antiresorptive or antiangiogenic agents for any reason including osteoporosis, multiple myeloma, bone metastasis of other primary cancers

They are unable to seek outpatient medical care or are not medically fit to withstand implant placement, including those with critical findings or lab values. Medical exclusion of patients will be completed by the investigators based on standard of care for surgical procedures in dental medicine and based on specific implant guidelines.

Patients who have routinely used tobacco or tobacco products in the last 1 year will be excluded, as tobacco use is a known contributor to poor prognosis after implant placement. For this reason, dental implant placement is only recommended in patients who have quit or never used tobacco products.

What this trial measures

Safety of implant placement in patients taking TNF-α inhibitorsHealing will be assessed over 1 year after implant placement
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.

Trialytics