Dental ImplantsNCT06538870
Dental Implant Healing With TNF-Alpha Inhibitors
A study testing Placement of dental implants in people with Dental Implants and TNF-alpha Inhibitors, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, TNF-alpha Inhibitors, Edentulism
- What is being tested?
- Placement of dental implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Renee Tangi contact
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, 19104
Rosa Urbina, 215-573-6243, rurbina@upenn.edu
Renee Tangi, pdmtranslationalmed@upenn.edu
About this study
Official title: Dental Implant Healing in Patients Taking Tumor Necrosis Factor (TNF)-Alpha Inhibitors
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.
Read the 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 3.75x11.5 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 3,6, and 12 month study visits, which will improve patient retention. Of these, the 3 month study visit would be routine during normal clinical care.
- Conditions
- Dental Implants, TNF-alpha Inhibitors, Edentulism
- Being tested
- Placement of dental implants
- Keywords
- Dental implants, TNF-alpha inhibitors, Biologic agents, Missing teeth, missing tooth
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of dental implantsProcedure or surgery
Dental implants will be placed in the edentulous area as per standard surgical procedure and as appropriate to bring the patient to standard of care restoratively.
| Study group | Role | What they receive |
|---|---|---|
| Patients taking TNF-alpha inhibitors | Experimental | Adult patients (18 years of age or older) taking a TNF-alpha inhibitor as defined by the NIH and missing teeth will be recruited to receive dental implant placement according to standard of care for ideal dental restoration. Patients must have been taking a stable dose of the drug for at least 6 months and have no contra-indications to implant placement (regular tobacco use in the last year, periodontal disease, pathology in the jaw bone(s), history of head and neck radiation, history of antiresorptive or antiangiogenic agents, uncontrolled diabetes, pregnancy, other medical conditions that preclude safe delivery of outpatient medical care) to be eligible for enrollment in the study. Receives: Procedure: Placement of dental implants |
| Patients not taking TNF-alpha inhibitors | Experimental | Patients over age 18 not taking TNF alpha inhibitors will be recruited and matched via age and sex to the patients taking TNF-alpha inhibitors. The general exclusion criteria (regular tobacco use in the last year, periodontal disease, pathology in the jaw bone(s), history of head and neck radiation, history of antiresorptive or antiangiogenic agents, uncontrolled diabetes, pregnancy, other medical conditions that preclude safe delivery of outpatient medical care) will apply to both arms equally. Receives: Procedure: Placement of dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of implant placement in patients taking TNF-α inhibitors
A pilot cohort of patients will be recruited who require implants for standard of care restoration for tooth loss. Patients will be evaluated pre- and post-operatively and followed for 1 year to assess healing using clinical exam.
Measured: Healing will be assessed over 1 year after implant placement
Secondary outcomes (2)
Patient pain after implant placement in patients receiving TNF-alpha inhibitors using patient rating scales
While no previous dental research has directly evaluated perception of healing in patients taking TNF-α inhibitors, previous evidence points to an increase in pain during surgical healing in patients taking BAs. Patient discomfort will be measured by visual analog (VAS) patient rating scales as are widely used after dental surgery. The VAS scale from 0 to 10 where 0 means no pain and 10 means the worst possible pain will be used.
Applying these outcomes to implant healing in patients taking TNF-α inhibitors will provide an assessment of patient experience. We hypothesize that there will be an increase in pain ratings compared to established expectations. This is the first study to evaluate patient discomfort after implant placement in patients taking BAs and the first prospective study of patients taking BAs in dental medicine and thus will add to the literature by characterizing healing and patient experience.
Measured: This will be assessed during the pre-surgical appointment to understand patient baseline and after surgery daily for the first week and then at 1 week, 1,3,6,and 12 months.
Patient pain after implant placement in patients receiving TNF-alpha inhibitors using analgesic use
While no previous dental research has directly evaluated perception of healing in patients taking TNF-α inhibitors, previous evidence points to an increase in pain during surgical healing in patients taking BAs. Patient discomfort as measured by analgesic use in number and timing of doses taken will be evaluated. Extrapolating these outcomes to implant healing in patients taking TNF-α inhibitors will provide an assessment of patient experience. We hypothesize that there will be an increase in analgesic need compared to established expectations, to be further evaluated according to additional factors, if present, at further study. This is the first study to evaluate patient discomfort after implant placement in patients taking BAs and the first prospective study of patients taking BAs in dental medicine and thus will add to the literature by characterizing healing and patient experience.
Measured: This will be assessed during the pre-surgical appointment to understand patient baseline and after surgery daily for the first week and then at 1 week, 1,3,6,and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start28 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups will be recruited, one taking TNF-alpha inhibitors and one not taking these medications but matched via age and sex to the first group. Both will receive dental implant placement to replace missing teeth and both will be followed at the same intervals, using the same outcome measures, and for the same length of time.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Nobel Biocare
- Responsible party
- Principal investigator, Katherine Theken, University of Pennsylvania
- Investigators
- Katherine Theken, PharmD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538870
- Sponsor's protocol ID
- 2023-1778 SA France
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD including patient outcome data will be available upon reasonable request from other researchers with similar studies, and will be shared only in aggregate and in anonymized form.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Implant Healing in Patients Taking Tumor Necrosis Factor (TNF)-Alpha Inhibitors
- ClinicalTrials.gov ID
- NCT06538870
- Acronym / sponsor ID
- 2023-1778 SA France
- Conditions
- Dental Implants, TNF-alpha Inhibitors, Edentulism
- Keywords
- Dental implants, TNF-alpha inhibitors, Biologic agents, Missing teeth, missing tooth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Nobel Biocare
- Study start
- 28 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 3.75x11.5 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 3,6, 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups will be recruited, one taking TNF-alpha inhibitors and one not taking these medications but matched via age and sex to the first group. Both will receive dental implant placement to replace missing teeth and both will be followed at the same intervals, using the same outcome measures, and for the same length of time.
| Arm | Type | Receives |
|---|---|---|
| Patients taking TNF-alpha inhibitors | Experimental | Procedure: Placement of dental implantsAdult patients (18 years of age or older) taking a TNF-alpha inhibitor as defined by the NIH and missing teeth will be recruited to receive dental implant placement according to standard of care for ideal dental restoration. Patients must have been taking a stable dose of the drug for at least 6 months and have no contra-indications to implant placement (regular tobacco use in the last year, periodontal disease, pathology in the jaw bone(s), history of head and neck radiation, history of antiresorptive or antiangiogenic agents, uncontrolled diabetes, pregnancy, other medical conditions that preclude safe delivery of outpatient medical care) to be eligible for enrollment in the study. |
| Patients not taking TNF-alpha inhibitors | Experimental | Procedure: Placement of dental implantsPatients over age 18 not taking TNF alpha inhibitors will be recruited and matched via age and sex to the patients taking TNF-alpha inhibitors. The general exclusion criteria (regular tobacco use in the last year, periodontal disease, pathology in the jaw bone(s), history of head and neck radiation, history of antiresorptive or antiangiogenic agents, uncontrolled diabetes, pregnancy, other medical conditions that preclude safe delivery of outpatient medical care) will apply to both arms equally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of dental implantsDental implants will be placed in the edentulous area as per standard surgical procedure and as appropriate to bring the patient to standard of care restoratively. | Procedure or surgery | Patients not taking TNF-alpha inhibitors, Patients taking TNF-alpha inhibitors |
Primary outcome
Safety of implant placement in patients taking TNF-α inhibitors
Time frame: Healing will be assessed over 1 year after implant placement
A pilot cohort of patients will be recruited who require implants for standard of care restoration for tooth loss. Patients will be evaluated pre- and post-operatively and followed for 1 year to assess healing using clinical exam.
2 secondary outcomes
Patient pain after implant placement in patients receiving TNF-alpha inhibitors using patient rating scales
Time frame: This will be assessed during the pre-surgical appointment to understand patient baseline and after surgery daily for the first week and then at 1 week, 1,3,6,and 12 months.
Patient pain after implant placement in patients receiving TNF-alpha inhibitors using analgesic use
Time frame: This will be assessed during the pre-surgical appointment to understand patient baseline and after surgery daily for the first week and then at 1 week, 1,3,6,and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. IPD including patient outcome data will be available upon reasonable request from other researchers with similar studies, and will be shared only in aggregate and in anonymized form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Renee Tangi contact
Katherine Theken, PharmD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of dental implants in people with Dental Implants and TNF-alpha Inhibitors, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosa Urbina (215-573-6243, rurbina@upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of implant placement in patients taking TNF-α inhibitors (time frame: Healing will be assessed over 1 year after implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.