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

Sponsor
I-Ching Wang (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06038695
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
35
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Device: Xenogeneic 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.
Other Names:
  • Fibro-Gide, Geistlich Pharma
  • GEM21S, Lynch Biologics

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Iowa College of Dentistry and Dental Clinics Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • I-Ching Wang

    Investigators

    • Principal Investigator: I-Ching Wang, DDS,MS, University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    I-Ching Wang, Clinical Assistant Professor, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT06038695
    Other Study ID Numbers:
    • 202212227
    First Posted:
    Sep 15, 2023
    Last Update Posted:
    Sep 15, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Mitogens

    Study Results

    No Results Posted as of Sep 15, 2023