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New treatment option for Edentulism
Official title Dental Implant Healing With TNF-Alpha Inhibitors
ClinicalTrials.gov ID: NCT06538870
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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
You likely can't join if
- Patients will not be excluded on the basis of age (within the adult population), race, economic status, sex or gender, or other demographic factors...
- They have periodontal disease (periodontal pockets above 4mm in the applicable arch or radiographic evidence of horizontal bone loss more than mild...
- There is other evidence of pathology in the treated arch on pre-treatment review including radiographs, such as any evidence of cyst or tumor...
- They have uncontrolled diabetes (HbA1c \>8.0) as confirmed by evaluating labs taken on anyone with diagnosed diabetes in the 6 months before the...
- 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...
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.