NCT06517030 Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials.
| NCT ID | NCT06517030 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Università Vita-Salute San Raffaele |
| Condition | Dental Implant |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-04 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06517030 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 70 Years, studying Dental Implant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06517030 currently recruiting?
Yes, NCT06517030 is actively recruiting participants. Contact the research team at giovannalauradd@gmail.com for enrollment information.
Where is the NCT06517030 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06517030 clinical trial?
NCT06517030 is sponsored by Università Vita-Salute San Raffaele. The trial plans to enroll 30 participants.