Dental Implant Healing With TNF-Alpha Inhibitors

Launched by UNIVERSITY OF PENNSYLVANIA · Jul 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well dental implants heal in people who take a specific type of medication called TNF-alpha inhibitors. These medications are often used to treat conditions like arthritis and other inflammatory diseases. The researchers want to find out if patients taking these drugs experience more complications or increased pain after getting dental implants compared to those who do not take these medications. To do this, they will recruit two groups of participants: one group will be taking TNF-alpha inhibitors and the other will not, but they will match them by age and gender.

To be eligible for this study, participants must be over 18 years old and need dental implants. They should be medically fit for the procedure and able to read and speak English. Participants will be followed for one year after their dental implants are placed, with regular visits to check their healing and pain levels. They will also keep a diary to track their pain and how much pain medication they use at home. This study aims to improve our understanding of how these medications affect healing after dental procedures.

Gender

ALL

Eligibility 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.