About this trial
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).
Eligibility criteria
Qualifiers
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).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Tooth Extraction
- Immediate Implant Placement
- Socket reconstruction with DBBB+HA
- Socket reconstruction with DBBB
- CTG placement