Immediate Implant Placement Using Volume-Stable Collagen Matrix Combined With rhPDGF-BB
- Conditions
- Tooth ExtractionImmediate Implant Placement
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Iowa College of Dentistry and Dental Clinics
🇺🇸Iowa City, Iowa, United States
University of Iowa College of Dentistry and Dental Clinics🇺🇸Iowa City, Iowa, United States