Healing after dental implant placement in patients using TNF-alpha inhibitors
Dental Implant Healing in Patients Taking Tumor Necrosis Factor (TNF)-Alpha Inhibitors
NA · University of Pennsylvania · NCT06538870
This study is testing how well dental implants heal in patients taking TNF-alpha inhibitors compared to those who aren't, to see if there are any differences in complications and pain after the procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06538870 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to investigate the healing process following dental implant placement in patients who are taking TNF-alpha inhibitors compared to those who are not. It will recruit 30 participants, with 15 taking TNF-alpha inhibitors and 15 matched controls, to assess complications and pain levels post-implant placement. Participants will be followed for one year with clinical examinations and radiographs to monitor their healing progress. The study will ensure that all patients receive the same type of dental implants and will not alter their medication regimen during the study.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who require dental implants and are either taking TNF-alpha inhibitors or are matched controls not on these medications.
Not a fit: Patients with periodontal disease or smokers may not benefit from this study due to known complications associated with these conditions.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and efficacy of dental implants in patients using TNF-alpha inhibitors, potentially improving treatment protocols.
How similar studies have performed: While there is limited data on this specific approach, studies involving TNF-alpha inhibitors in other contexts have shown varying outcomes, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: 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 * 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. * 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. * 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.
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania School of Dental Medicine — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Katherine Theken, PharmD, PhD — University of Pennsylvania
- Study coordinator: Stacey Secreto
- Email: secreto@upenn.edu
- Phone: 215-746-8871
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Edentulism, Dental Implants, TNF-alpha Inhibitors, Dental implants, TNF-alpha inhibitors, Biologic agents, Missing teeth