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Search / Trial NCT06517030

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

Launched by UNIVERSITÀ VITA-SALUTE SAN RAFFAELE · Jul 17, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a dental procedure that combines a technique called socket reconstruction with immediate placement of dental implants. The aim is to find out if using a special material made from deproteinized bovine bone and hyaluronic acid helps improve the height of the bone better than using just deproteinized bovine bone alone. This trial is being conducted at multiple locations across the country and involves both patients and examiners who do not know which treatment is being given, ensuring unbiased results.

To participate in this study, individuals must be between 18 and 75 years old and be in good overall health. They should have a single tooth that needs to be extracted and replaced with an implant, along with a specific bone condition that allows for this procedure. Participants will receive treatment for their dental issues and will be monitored throughout the trial. It's important to note that certain health conditions, such as severe diabetes or smoking more than ten cigarettes a day, may exclude someone from joining the study. This trial aims to provide valuable information that could improve dental implant treatments in the future.

Gender

ALL

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.

About Università Vita Salute San Raffaele

Università Vita-Salute San Raffaele is a prestigious Italian academic institution renowned for its commitment to advancing healthcare through innovative research and education. Located in Milan, it integrates cutting-edge scientific inquiry with clinical practice, fostering interdisciplinary collaboration among healthcare professionals. The university is dedicated to improving patient outcomes and public health by conducting rigorous clinical trials that adhere to the highest ethical standards. Its focus spans various medical fields, leveraging state-of-the-art facilities and a strong network of partnerships to drive advancements in medical science and contribute to the global healthcare community.

Locations

Milan, Mi, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported