Clinical trial NCT06038695: Immediate Implant Placement Using Volume-Stable Collagen Matrix Combined With rhPDGF-BB
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tooth Extraction
Immediate Implant Placement
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in from Baseline in Soft and Hard Tissue Thickness as assessed by ultrasound.
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa College of Dentistry and Dental Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: I-Ching Wang, DDS,MS
role: PRINCIPAL_INVESTIGATOR
References: