Tooth ExtractionNCT06038695
Immediate Implant Placement Using Volume-Stable Collagen Matrix Combined With rhPDGF-BB
A study testing Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB in people with Tooth Extraction and Immediate Implant Placement, run by I-Ching Wang at 1 site in United States.
Trial summary
The goal of this study is to test a volume-stable collagen matrix in combination with recombinant human platelet-derived growth factor-BB, specifically in patients who have an immediate implant placement for teeth #5-#12. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction, Immediate Implant Placement
- What is being tested?
- Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-95
- Has a single hopeless tooth in the maxillary esthetic zone (i.e., first premolar to first premolar, tooth #5-tooth #13)
- Adequate oral hygiene (i.e., full-mouth bleeding score (FMBS) and full mouth plaque score (FMPS) of less than 25%)
- Adequate tooth space to support an immediate implant placement (i.e., adequate mesiodistal space of greater than or equal to 6 mm and interocclusal space to support a non-occluding provisionalization).
- Postextraction vertical bone defect of the buccal socket wall was less than or equal to 3mm
Who cannot join
- patients taking long-term (more than 3 months) medications affecting bone metabolism
- generalized untreated periodontitis with greater than of 30% of sites with greater than 5mm pocket depths and bleeding upon probing with a dental probe
- medical contraindications for having a surgical procedure (i.e., ASA Status of III, patient with a severe systemic disease that is not life-threatening; ASA Status of IV, a patient with a severe systemic disease that is a constant threat to life).
- history of radiotherapy in the head and neck region
- heavy smoker (greater than 10 cigarettes per day)
- pregnancy
- gingival recession before extraction in relation to the contralateral tooth
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa College of Dentistry and Dental Clinics
Iowa City, Iowa, 52242
About this study
Official title: Ultrasound-based Imaging to Detect Early Changes of Hard and Soft Tissue Around Immediately Placed Implants With Volume-Stable Collagen Matrix Combined With rhPDGF-BB: Pilot Study
The goal of this study is to test a volume-stable collagen matrix in combination with recombinant human platelet-derived growth factor-BB, specifically in patients who have an immediate implant placement for teeth #5-#12.
The main question this study aims to answer is does the recombinant human platelet-derived growth factor-BB accelerate the formation of blood vessels and augment tissue volume around the immediate implant.
Participants will be asked to undergo immediate implant placement using volume-stable collagen matrix in combination with recombinant human platelet-derived growth factor-BB, as well as attend 11 study visits over the course of 1.25 years.
- Conditions
- Tooth Extraction, Immediate Implant Placement
- Being tested
- Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BBDevice
Also called Fibro-Gide, Geistlich Pharma, GEM21S, Lynch Biologics
- Fibro-Gide is the Volume-Stable Collagen Matrix.
- Recombinant human platelet-derived growth factor-BB will be found within the device of GEM21S.
| Study group | Role | What they receive |
|---|---|---|
| Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB | Experimental | Subjects in this arm will have a xenogeneic volume-stable collagen matrix in combination with recombinant human platelet-derived growth factor-BB at the time of immediate implant placement. Receives: Device: Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in from Baseline in Soft and Hard Tissue Thickness as assessed by ultrasound.
Tissues will be measured in millimeters.
Measured: Multiple time points (i.e. 0, Immediately after implant placement, 1 week, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 16 weeks, 24 weeks, and 48 weeks after immediate implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study startMay 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Currently, there is no capacity for this project in the institute
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- I-Ching Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, I-Ching Wang, University of Iowa
- Investigators
- I-Ching Wang, DDS,MS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038695
- Sponsor's protocol ID
- 202212227
- Status last verified
- Jun 2024
- First submitted
- 8 Sep 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-based Imaging to Detect Early Changes of Hard and Soft Tissue Around Immediately Placed Implants With Volume-Stable Collagen Matrix Combined With rhPDGF-BB: Pilot Study
- ClinicalTrials.gov ID
- NCT06038695
- Acronym / sponsor ID
- 202212227
- Conditions
- Tooth Extraction, Immediate Implant Placement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Currently, there is no capacity for this project in the institute
- Enrolment
- 0 participants (actual)
- Lead sponsor
- I-Ching WangUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Sep 2023 (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 study is to test a volume-stable collagen matrix in combination with recombinant human platelet-derived growth factor-BB, specifically in patients who have an immediate implant placement for teeth #5-#12.
The main question this study aims to answer is does the recombinant human platelet-derived growth factor-BB accelerate the formation of blood vessels and augment tissue volume around the immediate implant.
Participants will be asked to undergo immediate implant placement using volume-stable collagen matrix in combination with recombinant human platelet-derived growth factor-BB, as well as attend 11 study visits over the course of 1.25 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB | Experimental | Device: Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BBSubjects in this arm will have a xenogeneic volume-stable collagen matrix in combination with recombinant human platelet-derived growth factor-BB at the time of immediate implant placement. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-95
- Has a single hopeless tooth in the maxillary esthetic zone (i.e., first premolar to first premolar, tooth #5-tooth #13)
- Adequate oral hygiene (i.e., full-mouth bleeding score (FMBS) and full mouth plaque score (FMPS) of less than 25%)
- Adequate tooth space to support an immediate implant placement (i.e., adequate mesiodistal space of greater than or equal to 6 mm and interocclusal space to support a non-occluding provisionalization).
- Postextraction vertical bone defect of the buccal socket wall was less than or equal to 3mm
Key exclusion criteria (7 listed)
- patients taking long-term (more than 3 months) medications affecting bone metabolism
- generalized untreated periodontitis with greater than of 30% of sites with greater than 5mm pocket depths and bleeding upon probing with a dental probe
- medical contraindications for having a surgical procedure (i.e., ASA Status of III, patient with a severe systemic disease that is not life-threatening; ASA Status of IV, a patient with a severe systemic disease that is a constant threat to life).
- history of radiotherapy in the head and neck region
- heavy smoker (greater than 10 cigarettes per day)
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 |
|---|---|---|
| Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BBAlso: Fibro-Gide, Geistlich Pharma, GEM21S, Lynch Biologics* Fibro-Gide is the Volume-Stable Collagen Matrix. * Recombinant human platelet-derived growth factor-BB will be found within the device of GEM21S. | Device | Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB |
Primary outcome
Change in from Baseline in Soft and Hard Tissue Thickness as assessed by ultrasound.
Time frame: Multiple time points (i.e. 0, Immediately after implant placement, 1 week, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 16 weeks, 24 weeks, and 48 weeks after immediate implant placement
Tissues will be measured in millimeters.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
I-Ching Wang, DDS,MS principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB in people with Tooth Extraction and Immediate Implant Placement, run by I-Ching Wang 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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 18 Jun 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in from Baseline in Soft and Hard Tissue Thickness as assessed by ultrasound. (time frame: Multiple time points (i.e. 0, Immediately after implant placement, 1 week, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 16 weeks, 24 weeks, and 48 weeks after immediate 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 18 Jun 2024.