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

NCT06038695 | Withdrawn FDA Device

• 1 other identifier: 202212227
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Extraction; Immediate Implant Placement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

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

Interventions

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

* Fibro-Gide is the Volume-Stable Collagen Matrix. * Recombinant human platelet-derived growth factor-BB will be found within the device of GEM21S.

Also known as: Fibro-Gide, Geistlich Pharma, GEM21S, Lynch Biologics

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

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I-Ching Wang: lead

Study Sites (1)

University of Iowa College of Dentistry and Dental Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Transplantation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• I-Ching Wang, DDS,MS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)