Immediate Implant Placement Using Volume-Stable Collagen Matrix Combined With rhPDGF-BB

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tooth Extraction, Immediate Implant Placement

Intervention / Treatment
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* Device: Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB<br>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. | Device: Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB<br>* Fibro-Gide is the Volume-Stable Collagen Matrix. Recombinant human platelet-derived growth factor-BB will be found within the device of GEM21S.<br>* Other names: GEM21S, Lynch Biologics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in from Baseline in Soft and Hard Tissue Thickness as assessed by ultrasound. | Tissues will be measured in millimeters. | 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 |