Tooth ExtractionImmediate Implant PlacementSocket reconstruction with DBBB+HASocket reconstruction with DBBBCTG placement
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.
Study 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).
Eligibility
Sex
ALL
Min age
22 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Participant is willing and able to give informed consent for participation in the trial.
2. In good general health as evidenced by medical history.
3. 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.
4. Presence of \>3mm of buccal wall dehiscence evaluated using Cone Beam Computed Tomography (CBCT).
5. In healthy periodontal conditions (i.e., no presence of sites ≥ 4 mm and/or presence of intra-bony defects in the selected sites, full mouth plaque score \< 20% and full-mouth bleeding score \< 20%).
Exclusion Criteria:
1. Current or previous use of immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
2. Presence of inflammatory and autoimmune disease of the oral cavity.
3. Severe or poorly controlled diabetes or previous radiotherapy of head area.
4. Contraindications to dental and/or surgical interventions (e.g. severe endocrine bone diseases, severe metabolic bone disorders, malignant tumour diseases).
5. Individuals who are smokers of \>10 cigarettes/day.
6. Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
7. Presence of \<3mm of dehiscence of buccal walls of the socket after tooth extraction.
8. Presence of a distance between the interdental bone crest and buccal bone crest \<3 mm after tooth extraction.
Primary outcome measure(s)
Vertical buccal bone height changes (∆VBBH). — at baseline and at 6 months after procedure 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)
Trial sites (1)
Facility
City
Region
Status
Ospedale San Raffaele
Milan
Mi
Recruiting
More Università Vita-Salute San Raffaele trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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