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

Not Applicable

Withdrawn

• Conditions: Tooth Extraction; Immediate Implant Placement
• Interventions: Device: Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB

• Registration Number: NCT06038695
• Lead Sponsor: I-Ching Wang

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18
• Study Start: 2025-05
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB	Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Iowa College of Dentistry and Dental Clinics; 🇺🇸 Iowa City, Iowa, United States