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

NCT06517030 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-16

No results posted yet for this study

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).

Conditions

  • Dental Implant

Interventions

PROCEDURE

Tooth Extraction

After local anaesthesia, a buccal split-full-split-thickness envelope flap will be elevated, and the tooth will be extracted a-traumatically.

PROCEDURE

Immediate Implant Placement

After providing that the extraction socket will meet the inclusion criteria, an implant will be immediately inserted with 1 mm of its transmucosal portion positioned under the interproximal bone crest.

PROCEDURE

Socket reconstruction with DBBB+HA

The gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral with hyaluronic acid (DBBM+HA).

PROCEDURE

Socket reconstruction with DBBB

The gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral (DBBM).

PROCEDURE

CTG placement

Once the appropriate healing abutments will be installed, a CTG will be utilized as a barrier membrane. Then, the buccal flap will be coronally advanced and will be adapted to the healing abutment.

Sponsors & Collaborators

  • Università Vita-Salute San Raffaele

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-06-30
Completion
2025-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06517030 on ClinicalTrials.gov