Actively Recruiting

Phase Not Applicable
Age: 22Years - 70Years
All Genders
Healthy Volunteers
NCT06517030

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

Age: 22Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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%
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Ospedale San Raffaele

Milan, Mi, Italy

Actively Recruiting

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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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