Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials.
NCT Number: NCT06517030
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Implant
Interventions: PROCEDURE: Tooth Extraction|PROCEDURE: Immediate Implant Placement|PROCEDURE: Socket reconstruction with DBBB+HA|PROCEDURE: Socket reconstruction with DBBB|PROCEDURE: CTG placement
Sponsor: Università Vita-Salute San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-09

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).

Primary Outcome Measures: Vertical buccal bone height changes (∆VBBH)., the vertical linear distance from point A (the most coronal point of the buccal crest of the baseline socket) to point B (the most coronal point of the buccal crest at 6 months after implant insertion), at baseline and at 6 months after procedure
Secondary Outcome Measures: Width of keratinized tissue (KTW)., Measured at the buccal aspect, as the distance between gingival margin and mucogingival junction., at baseline and at 6 months after treatment.|Soft tissue contour changes., Linear and volumetric measurements will be performed using Stl files superimposition., at baseline and at 6 months after treatment.|Soft tissue thickness (STT)., Superimposition of DICOM file, representing hard tissue volume, to STL file representing soft tissue contour, will be used to measure the buccal soft tissue thickness in the two different treatment groups., at baseline and at 6 months after treatment.|Horizontal Buccal Bone Changes., The horizontal linear distance between the outer surface of buccal bone at baseline and that at 6 months will be evaluated., at baseline and at 6 months after treatment.|Osseous Ridge Width Changes., the horizontal linear distance from the outer surface of buccal bone to the outer surface of palatal/lingual bone, measured at baseline and at 6 months. The osseous ridge width changes in millimetres (mm) and in percentage (%ORR) will be also calculated., at baseline and at 6 months after treatment.|Wound healing index (WHI)., The following criteria will be used:

* score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort or flap dehiscence + intact papillae height
* score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration + reduced papillae height
* score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration + loss of papillae height, at 7 and 14 days after treatment.|Post-surgical pain (PP), Subjects will be also asked to evaluate pain perception at day 7 and day 14 using a visual analogue scale (VAS) score (0 = no pain 10 = maximal pain)., at 7 and 14 days after treatment.|Amount of drug intake, The daily consumption of analgesics/anti-inflammatory medications from the day of surgery until day 14 will be calculated., from the day of surgery until day 14|Handling of materials., The clinical handling of the two grafts will be assessed retrospectively by the surgeons using a visual analogue scale (VAS, 0 = easy to be applied, 10 = very difficult to be applied), at the day of the surgery