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RECRUITING
NCT06517030
NA

Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials.

Sponsor: Università Vita-Salute San Raffaele

View on ClinicalTrials.gov

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

PROCEDURE

Tooth Extraction

After local anaesthesia, a buccal split-full-split-thickness envelope flap will be elevated, and the tooth will be extracted a-traumatically.

PROCEDURE

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.

PROCEDURE

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).

PROCEDURE

Socket reconstruction with DBBB

The gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral (DBBM).

PROCEDURE

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