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

I-Ching Wang

Status: Withdrawn

Conditions: Tooth Extraction; Immediate Implant Placement

Treatments: Device: Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB

Study type: Interventional

Funder types: Other

Identifiers

NCT06038695

202212227

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB

Experimental group

Description:

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.

Treatment:

Device: Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB