Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06538870

Dental Implant Healing With TNF-Alpha Inhibitors

Led by University of Pennsylvania · Updated on 2026-05-11

30

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

Sponsors

U

University of Pennsylvania

Lead Sponsor

N

Nobel Biocare

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Dental Implant Healing With TNF-Alpha Inhibitors

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Over the age of 18
  • Require placement of implants to assist with dental restoration
  • Taking a stable dose of TNF-alpha inhibitor medication for at least 6 months, or not taking TNF-alpha inhibitors but matched by age and gender
  • Medically fit to withstand implant placement as judged by the study team
  • Able to read and speak English
  • Able to provide independent consent or attend visits with a surrogate decision maker
Not Eligible

You will not qualify if you...

  • Presence of periodontal disease with pockets above 4mm or significant bone loss
  • Evidence of cyst or tumor formation in the jawbone on radiographs
  • Uncontrolled diabetes with HbA1c greater than 8.0
  • History of head and neck radiation
  • Use of antiresorptive or antiangiogenic agents
  • Not medically fit for implant placement or unable to seek outpatient care
  • Tobacco or tobacco product use within the last year
  • Pregnancy (typically excluded as implant placement is elective and deferred until after delivery)

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Trial Site Locations

Total: 1 location

1

University of Pennsylvania School of Dental Medicine

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

S

Stacey Secreto

CONTACT

K

Katherine Theken, PharmD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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