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Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials.
Sponsor: Università Vita-Salute San Raffaele
Summary
The present research is a national multicentric prospective parallel double-blinded (both the patient and the examiner are blind) randomized controlled clinical trial. It is a superiority comparative study on a medical device CE (conformité européenne) marking, used according to the intended use subject to the CE marking. The hypothesis tested is: the socket reconstruction procedure performed in conjunction with Immediate implant placement (IIP) with the use of Deproteinized bovine bone mineral + hyaluronic acid (DBBM+HA, Cerabone plus) leads to a greater increase in the vertical buccal bone height than same procedure with deproteinized bovine bone mineral alone (DBBM, Bio-oss Collagen).
Official title: Clinical and Radiographic Evaluation of a Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials: a Multicentric Randomized Clinical Trial.
Key Details
Gender
All
Age Range
22 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-04
Completion Date
2025-09
Last Updated
2025-04-16
Healthy Volunteers
Yes
Conditions
Interventions
Tooth Extraction
After local anaesthesia, a buccal split-full-split-thickness envelope flap will be elevated, and the tooth will be extracted a-traumatically.
Immediate Implant Placement
After providing that the extraction socket will meet the inclusion criteria, an implant will be immediately inserted with 1 mm of its transmucosal portion positioned under the interproximal bone crest.
Socket reconstruction with DBBB+HA
The gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral with hyaluronic acid (DBBM+HA).
Socket reconstruction with DBBB
The gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral (DBBM).
CTG placement
Once the appropriate healing abutments will be installed, a CTG will be utilized as a barrier membrane. Then, the buccal flap will be coronally advanced and will be adapted to the healing abutment.
Locations (1)
Ospedale San Raffaele
Milan, Mi, Italy