Dental Implant Healing With TNF-Alpha Inhibitors

Conditions

• Dental Implants
• Edentulism
• TNF-alpha Inhibitors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Placement of dental implants — PROCEDURE
  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.

Study Details

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.

Key Dates

Start date

Jun 28, 2025

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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

• Stacey Secreto
  215-746-8871
  [email protected]
• Katherine Theken, PharmD, PhD
  [email protected]

Locations (1)

Find similar trials in Philadelphia, PA

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