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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 enrollme…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of implant placement in patients taking TNF-α inhibitors
Timeframe: Healing will be assessed over 1 year after implant placement