Recruiting

TNF-Alpha Inhibitors

Sponsor:

University of Pennsylvania

Code:

NCT06538870

Conditions

Edentulism

Dental Implants

TNF-alpha Inhibitors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Placement of dental implants

Study Details

Brief 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.

Conditions

Edentulism

Dental Implants

TNF-alpha Inhibitors

Study ID

NCT06538870

Start date

Jun 28, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

Patients will not be excluded on the basis of age (within the adult population), race, economic status, sex or gender, or other demographic factors. Patients will be excluded if:

  • 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.

  • Pregnant women are unlikely to meet inclusion criteria as dental implant placement is considered an elective procedure and typically deferred in dentistry until after delivery.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Placement of dental implants

Dental implants will be placed in the edentulous area as per standard surgical procedure and as appropriate to bring the patient to standard of care restoratively.

Primary outcome measure

  • Safety of implant placement in patients taking TNF-α inhibitors [ Time Frame: Healing will be assessed over 1 year after implant placement ]

Central Contacts and Locations

Central contacts

Stacey Secreto

215-746-8871secreto@upenn.edu

Katherine Theken, PharmD, PhD

pdmtranslationalmed@dental.upenn.edu

Locations

University of Pennsylvania School of Dental Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Stacey Secreto, CCRC

215-746-8871secreto@upenn.edu

Katherine Theken, PharmD, PhD

ktheken@upenn.edu

Principal Investigator:

Neeraj Panchal, DMD, MD, MA

More Information

Sponsor

University of Pennsylvania

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Keywords

  • Dental implants
  • TNF-alpha inhibitors
  • Biologic agents
  • Missing teeth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-09-03.