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
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.
| Status | Not yet recruiting |
| Enrollment | 12 |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Iowa College of Dentistry and Dental Clinics | Iowa City | Iowa |
| Lead Sponsor | Collaborator |
|---|---|
| I-Ching Wang |
United States,
| 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 |
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