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).
Participant is willing and able to give informed consent for participation in the trial.
In good general health as evidenced by medical history.
Presenting a single hopeless tooth candidate for extraction in the maxillary or mandibular area (from second premolar to second premolar, intercalated or the last tooth of dental arch) in need of a single implant-supported fixed prosthetic rehabilitation.
Presence of >3mm of buccal wall dehiscence evaluated using Cone Beam Computed Tomography (CBCT).
Current or previous use of immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
Presence of inflammatory and autoimmune disease of the oral cavity.
Severe or poorly controlled diabetes or previous radiotherapy of head area.
Contraindications to dental and/or surgical interventions (e.g. severe endocrine bone diseases, severe metabolic bone disorders, malignant tumour diseases).
Parallel
Tooth Extraction
Procedure/SurgeryAfter local anaesthesia, a buccal split-full-split-thickness envelope flap will be elevated, and the tooth will be extracted a-traumatically.
Immediate Implant Placement
Procedure/SurgeryAfter 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
Procedure/SurgeryThe 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
Procedure/SurgeryThe gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral (DBBM).
CTG placement
Procedure/SurgeryOnce 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.
Vertical buccal bone height changes (∆VBBH).
the vertical linear distance from point A (the most coronal point of the buccal crest of the baseline socket) to point B (the most coronal point of the buccal crest at 6 months after implant insertion)
Width of keratinized tissue (KTW).
Measured at the buccal aspect, as the distance between gingival margin and mucogingival junction.
Soft tissue contour changes.
Linear and volumetric measurements will be performed using Stl files superimposition.
Soft tissue thickness (STT).
Superimposition of DICOM file, representing hard tissue volume, to STL file representing soft tissue contour, will be used to measure the buccal soft tissue thickness in the two different treatment groups.
Horizontal Buccal Bone Changes.
The horizontal linear distance between the outer surface of buccal bone at baseline and that at 6 months will be evaluated.
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