Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538870
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Dental Implant Healing with TNF-Alpha Inhibitors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dental Implant Healing in Patients Taking Tumor Necrosis Factor TNF-alpha Inhibitors
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
This descriptive study will recruit 15 patients requiring implant restoration as standard of care for missing teeth taking a stable dose unchanged for 6 months or more of a TNF-α inhibitor regardless of the targeted disease and 15 patients requiring implant restoration not taking TNF-alpha inhibitors 30 patients total Patients will be recruited without age restrictions or limitations on systemic medical conditions or other medications although patients not taking TNF-alpha inhibitors will be matched via age and sex to those taking the medications Patients with periodontal disease and smokers will not be included given the known connection between these comorbidities and compromised implant outcomes Patients will be selected based on inclusion and exclusion criteria consent availability and willingness to follow study protocols Patients will not stop their TNF-alpha or any other medication during the study period to minimize adverse systemic outcomes
Once enrolled subjects will be evaluated according to medical history including reason for TNF inhibitor demographics and clinical and radiographic features NobelParallel conical connection implants will be placed under standard surgical approach to confirm equanimity of experience Nobel anatomical healing abutments will be placed above each implant and followed for 12 months according to study procedures All patients will receive the same dental implants specifically the NobelParallel TiUltra 375x115 implant and titanium healing abutment see product guide attached
Follow up appointments will assess healing including pain score and analgesic use routine standard of care but will be recorded as part of this research study periodontal probing and radiographs Radiographs will determine bone quality and quantity Nature and frequency have been planned according to best practices with details found below The images proposed that are additional to routine clinical care are CBCT immediately after implant placement CBCT at 6 months following implant placement periapical radiographs at 6 and 12 months after implant placement Patient serum will be drawn at the implant placement and all follow up visits to test for complete blood count C-reactive protein and erythrocyte sedimentation rate to assess systemic inflammation and any changes after surgery If patients complete all study visits their implant placement surgical treatment will be financially covered in full Patients will also be compensated for their time during the 36 and 12 month study visits which will improve patient retention Of these the 3 month study visit would be routine during normal clinical care
Once enrolled subjects will be evaluated according to medical history including reason for TNF inhibitor demographics and clinical and radiographic features NobelParallel conical connection implants will be placed under standard surgical approach to confirm equanimity of experience Nobel anatomical healing abutments will be placed above each implant and followed for 12 months according to study procedures All patients will receive the same dental implants specifically the NobelParallel TiUltra 375x115 implant and titanium healing abutment see product guide attached
Follow up appointments will assess healing including pain score and analgesic use routine standard of care but will be recorded as part of this research study periodontal probing and radiographs Radiographs will determine bone quality and quantity Nature and frequency have been planned according to best practices with details found below The images proposed that are additional to routine clinical care are CBCT immediately after implant placement CBCT at 6 months following implant placement periapical radiographs at 6 and 12 months after implant placement Patient serum will be drawn at the implant placement and all follow up visits to test for complete blood count C-reactive protein and erythrocyte sedimentation rate to assess systemic inflammation and any changes after surgery If patients complete all study visits their implant placement surgical treatment will be financially covered in full Patients will also be compensated for their time during the 36 and 12 month study visits which will improve patient retention Of these the 3 month study visit would be routine during normal clinical care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None