Immediate Implant Placement, Tooth Extraction
Conditions
Brief 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. 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.
Interventions
DEVICEXenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB
* Fibro-Gide is the Volume-Stable Collagen Matrix. * Recombinant human platelet-derived growth factor-BB will be found within the device of GEM21S.
Sponsors
I-Ching Wang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in from Baseline in Soft and Hard Tissue Thickness as assessed by ultrasound. | 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. |
Countries
United States
Outcome results
None listed