An interventional study of Tooth Extraction and Immediate Implant Placement in Dental Implant, sponsored by Università Vita-Salute San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 22 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by Università Vita-Salute San Raffaele · Not applicable, Interventional, and Treatment
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).
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 trial. It is a superiority comparative study on a medical device CE marking, used according to the intended use subject to the CE marking.
The hypothesis tested is: the socket reconstruction procedure performed in conjunction with IIP with the use of DBBM+HA leads to a greater increase in the vertical buccal bone height than same procedure with DBBM alone.
The present study will be reported according to the CONSORT statement for improving the quality of reports of parallel-group randomized trials (http://www.consort-statement.org/).
Patients will be randomly treated by means of IIP+connective tissue graft (CTG)+DBBM+HA (Test group or A group) or IIP+CTG+DBBM (Control group or B group). A randomization list will be generated in blocks: patients will be divided in 3 blocks according to the study center (M=San Raffaele Hospital, Milan; B=University of Bologna; S=University of Siena) and the treatment will be assigned at random in each block to ensure a balanced distribution of the tested interventions, with a ratio test:control=1:1. The investigator who will generate the allocation sequence will not be the person who will determine eligibility and entry of patients. The assignments (A or B group) will enclose in serially numbered, opaque, sealed envelopes, each bearing on the outside only the letter corresponding to the name of the center (M, B, S) and a number (from 1 to 10). A designated investigator for each center will be responsible to ensure that the envelopes will be opened sequentially, and only after the patient will undergo extraction of the hopeless tooth, implant placement, and clinical measurement assessment. For each patient, a sequential number will be assigned based on the date of enrollment, and the envelope with the corresponding number will be opened for each of them.
Both the investigator who will perform the measurements and the patients will be blinded to the randomization. The principal investigator (PI) will make sure patients are blind by simply not telling them there is a difference between the two medical devices; while he will ensure that investigator (who will perform the measurements) is blind by assigning a code or an identifying number to the two treatment groups so that they cannot know which device has been used.
Patients will be followed for 6 months after surgery.
The undermentioned 5 follow-up visits, which are standard of practice for all implant-bearing patients, will be scheduled for each patient for both treatment groups at:
After the visit at 6 months, each patient will then be considered "off study" (e.g. subject has completed treatment and all follow-up visits).
Università Vita-Salute San Raffaele is the lead sponsor of 84 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In Test group, the gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral with hyaluronic acid (Botiss Cerabone Plus; Botiss biomaterials, Hauptstr. 28 15806 Zossen, Germany). The material will be pre-wetted in saline, inserted in the gap and once soaked in blood, it will be gently pressed to the bone walls to completely fill the space and around buccal aspects of the exposed implant surface, up to the top of the abutment.
Procedure: Tooth Extraction · Procedure: Immediate Implant Placement · Procedure: Socket reconstruction with DBBB+HA · Procedure: CTG placement
In Control group, deproteinized bovine bone mineral (DBBM) (Bio-Oss Collagen; Geistlich Pharma, Wolhusen, Switzerland) will be positioned in the gap. The material will be pre-wetted in saline, inserted in the gap and once soaked in blood, it will be gently pressed to the bone walls to completely fill the space and around buccal aspects of the exposed implant surface, up to the top of the abutment.
Procedure: Tooth Extraction · Procedure: Immediate Implant Placement · Procedure: Socket reconstruction with DBBB · Procedure: CTG placement
After local anaesthesia, a buccal split-full-split-thickness envelope flap will be elevated, and the tooth will be extracted a-traumatically.
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.
The gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral with hyaluronic acid (DBBM+HA).
The gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral (DBBM).
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.
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)
Time frame: at baseline and at 6 months after procedure
Width of keratinized tissue (KTW).
Measured at the buccal aspect, as the distance between gingival margin and mucogingival junction.
Time frame: at baseline and at 6 months after treatment.
Soft tissue contour changes.
Linear and volumetric measurements will be performed using Stl files superimposition.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: at the day of the surgery
Plan to share: No
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Università Vita-Salute San Raffaele