Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials.
Clinical and Radiographic Evaluation of a Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials: a Multicentric Randomized Clinical Trial.
Università Vita-Salute San Raffaele
30 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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).
- 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 Criteria8
- 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).
- Individuals who are smokers of >10 cigarettes/day.
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- Presence of <3mm of dehiscence of buccal walls of the socket after tooth extraction.
- Presence of a distance between the interdental bone crest and buccal bone crest <3 mm after tooth extraction.
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Interventions
After local anaesthesia, a buccal split-full-split-thickness envelope flap will be elevated, and the tooth will be extracted a-traumatically.
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.
The gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral with hyaluronic acid (DBBM+HA).
The gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral (DBBM).
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)
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NCT06517030