Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06538870

Dental Implant Healing in Patients Taking Tumor Necrosis Factor (TNF)-Alpha Inhibitors

Led by University of Pennsylvania · Updated on 2026-05-20

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Pennsylvania

Lead Sponsor

N

Nobel Biocare

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating healing after dental implant placement in adults missing teeth who are either taking or not taking TNF-alpha inhibitor drugs, a class of biologic medications. The study aims to find out if patients on TNF-alpha inhibitors have more complications or experience increased pain compared to those not on these drugs. The study will recruit 30 patients total, half on stable doses of TNF-alpha inhibitors and half matched by age and sex not taking these drugs, excluding those with periodontal disease or recent tobacco use due to their impact on implant outcomes. Participants will receive the same type of dental implant (NobelParallel TiUltra 3.75x11.5) and healing abutment placed by standard surgical methods. Follow-up will last 12 months, including clinical exams, pain rating diaries, analgesic use records, periodontal probing, and multiple radiographs such as CBCT scans immediately after implant placement and at 6 months, plus periapical radiographs at 6 and 12 months. Blood samples will be collected throughout to monitor inflammation markers. During the one-year study, patients will attend visits at baseline, 3, 6, and 12 months to assess implant healing and pain levels. Researchers will track safety of implant placement and monitor bone quality and implant status using clinical exams and imaging. Pain will be measured with patient-reported scales and analgesic consumption. Patients completing all visits will have their implant surgery costs covered and receive compensation for their time at some visits. The study is sponsored by the University of Pennsylvania and aims to improve understanding of implant healing with TNF-alpha inhibitor use.

CONDITIONS

Brief 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 matched by age and gender if not taking these drugs
  • Medically fit to safely undergo implant placement
  • Able to read and speak English
  • Provide independent consent or attend study 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 cysts, tumors, or other pathology in the jaw bone
  • Uncontrolled diabetes with HbA1c greater than 8.0
  • History of head and neck radiation
  • Use of antiresorptive or antiangiogenic agents
  • Inability to safely receive outpatient medical or dental care
  • Regular tobacco use within the last year
  • Pregnancy or planning pregnancy during the study period

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 12 months

Participants receive dental implant placement following a standard surgical procedure and healing abutments are placed. Participants continue their TNF-alpha inhibitor medication if applicable.

1 implant placement visit and multiple follow-up visits at 1 week, 1 month, 3 months, 6 months, and 12 months

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

K

Katherine Theken, PharmD, PhD

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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