Healing after dental implant placement in patients using TNF-alpha inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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: Rosa Urbina
• Email: rurbina@upenn.edu
• Phone: 215-573-6243

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.