Status:

RECRUITING

Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials.

Lead Sponsor:

Università Vita-Salute San Raffaele

Conditions:

Dental Implant

Eligibility:

All Genders

22-70 years

Phase:

NA

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 ...

Detailed Description

The present research is a national multicentric prospective parallel double-blinded (both the patient and the investigator who will perform the measurements are blind) randomized controlled clinical t...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

April 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2025

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06517030

Start Date

April 1 2025

End Date

September 1 2025

Last Update

April 16 2025

Active Locations (1)

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1

Ospedale San Raffaele

Milan, Mi, Italy