RECRUITING

Dental Implant Healing With TNF-Alpha Inhibitors

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Conditions

EdentulismDental ImplantsTNF-alpha InhibitorsBiologic agentsMissing teeth

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06538870

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Over the age of 18
  2. * Require placement of implants to assist with dental restoration.
  3. * 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.
  4. * All patients will be medically fit to withstand implant placement as judged by best practice applied by the study team.
  5. * The patients will be required to read and speak English
  6. * All patients must either provide their own independent consent for medical procedures or to attend study visits with a surrogate decision maker.
  1. * They have periodontal disease (periodontal pockets above 4mm in the applicable arch or radiographic evidence of horizontal bone loss more than mild severity)
  2. * 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.
  3. * 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.
  4. * They have history of head and neck radiation for any reason
  5. * They are taking any antiresorptive or antiangiogenic agents for any reason including osteoporosis, multiple myeloma, bone metastasis of other primary cancers
  6. * 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.
  7. * 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.
  8. * 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.

Contacts and Locations

Study Contact

Katherine France, DMD, MBE
CONTACT
215-746-2550
kfrance@upenn.edu
Stacey Secreto, CCRC
CONTACT
2157462550
kfrance@upenn.edu

Principal Investigator

Katherine France, DMD, MBE
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Katherine France, DMD, MBE, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-01
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Edentulism
  • Dental Implants
  • TNF-alpha Inhibitors