Dental Implant Healing With TNF-Alpha Inhibitors

NCT06538870 | Recruiting

• 1 other identifier: 2023-1778 SA France
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Dental Implants; TNF-alpha Inhibitors; Edentulism

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety of implant placement in patients taking TNF-α inhibitors

  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.

  Healing will be assessed over 1 year after implant placement

Secondary Outcomes (2)

• Patient pain after implant placement in patients receiving TNF-alpha inhibitors using patient rating scales

  This will be assessed during the pre-surgical appointment to understand patient baseline and after surgery daily for the first week and then at 1 week, 1,3,6,and 12 months.

• Patient pain after implant placement in patients receiving TNF-alpha inhibitors using analgesic use

  This will be assessed during the pre-surgical appointment to understand patient baseline and after surgery daily for the first week and then at 1 week, 1,3,6,and 12 months.

Other Outcomes (1)

• Systemic levels of inflammatory markers

  Blood will be drawn for lab tests at implant visit and at follow up visits (1 week, 1 month, 3 month, 6 month, 12 month) to trend values.

Study Arms (2)

Patients taking TNF-alpha inhibitors

EXPERIMENTAL

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.

Procedure: Placement of dental implants

Patients not taking TNF-alpha inhibitors

EXPERIMENTAL

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.

Procedure: Placement of dental implants

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.

Patients not taking TNF-alpha inhibitors; Patients taking TNF-alpha inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Nobel Biocare: collaborator

Study Sites (1)

University of Pennsylvania School of Dental Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Katherine France, DMD, MBE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine France, DMD, MBE

CONTACT

215-746-2550; kfrance@upenn.edu

Stacey Secreto, CCRC

CONTACT

2157462550; kfrance@upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Oral Medicine

Model Details: Two groups will be recruited, one taking TNF-alpha inhibitors and one not taking these medications but matched via age and sex to the first group. Both will receive dental implant placement to replace missing teeth and both will be followed at the same intervals, using the same outcome measures, and for the same length of time.

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 6, 2024
• Study Start: June 28, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for 5 years after study close on reasonable request to the investigators and in aggregate form.
• Access Criteria: Interested investigators may contact the study team to obtain access to the data or supporting documents.

Locations

US (1)