Actively Recruiting
Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials.
Led by Università Vita-Salute San Raffaele · Updated on 2025-04-16
30
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give informed consent for participation in the trial
- In good general health based on medical history
- Have a single hopeless tooth in the maxillary or mandibular area (from second premolar to second premolar) needing single implant-supported fixed prosthetic rehabilitation
- Presence of more than 3 mm of buccal wall dehiscence assessed by Cone Beam Computed Tomography (CBCT)
- Healthy periodontal conditions with no sites of 4 mm or more, no intra-bony defects, full mouth plaque score under 20%, and full mouth bleeding score under 20%
You will not qualify if you...
- Current or previous use of immunosuppressants, bisphosphonates, or high-dose corticosteroids
- Presence of inflammatory or autoimmune diseases in the oral cavity
- Severe or poorly controlled diabetes or previous head area radiotherapy
- Contraindications to dental or surgical interventions such as severe endocrine bone diseases, severe metabolic bone disorders, or malignant tumors
- Smoking more than 10 cigarettes per day
- Female who is pregnant, lactating, or planning pregnancy during the study
- Less than 3 mm of buccal wall dehiscence after tooth extraction
- Distance between interdental bone crest and buccal bone crest less than 3 mm after tooth extraction
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ospedale San Raffaele
Milan, Mi, Italy
Actively Recruiting
Research Team
G
Giovanna Laura Di Domenico
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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