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

Tooth Extraction Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06038695
• Other study ID #: 202212227
• Status: Withdrawn
• Phase: N/A
• Start date: May 2025
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Immediate Implant Placement
• Tooth Extraction

Intervention

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.

Locations

Country	Name	City	State
United States	University of Iowa College of Dentistry and Dental Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
I-Ching Wang

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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