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

Not Applicable

Recruiting

• 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

• Registration Number: NCT06517030
• Lead Sponsor: Università Vita-Salute San Raffaele

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 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).

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 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:

1. 7±2 days post-surgery - clinical and photographic examination, collection of VAS (Visual Analogue Scale).

2. 14±4 days post-surgery - suture removal, clinical and photographic examination.

3. 1 month±7 days post-surgery - clinical and photographic examination.

4. 3 months±5 days post-surgery - clinical and photographic examination, measurements of the following parameters: Gingival recession depth (REC in mm), Keratinized tissue width (KTW in mm), Soft tissue thickness (GT in mm), Pocket probing depth (PPD in mm), Bleeding on probing (BoP), Plaque index (PI).

5. 6 months ±1 month post-surgery - clinical and photographic examination, CBCT scan, periapical radiography, 3D digital dental impression, measurements of the following parameters: Gingival recession depth (REC in mm), Keratinized tissue width (KTW in mm), Pocket probing depth (PPD in mm), Bleeding on probing (BoP), Plaque index (PI).

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).

Study Timeline

• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-24
• Status Verified: 2025-04
• Study Start: 2025-04
• Last Update Submitted: 2025-04-12
• Last Update Posted: 2025-04-16
• Primary Completion: 2025-06
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (DBBM)	Immediate Implant 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.
Test group (DBBM+HA)	Socket reconstruction with DBBB+HA	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.
Control group (DBBM)	Tooth Extraction	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.
Control group (DBBM)	Socket reconstruction with DBBB	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.
Control group (DBBM)	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.
Test group (DBBM+HA)	Tooth Extraction	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.
Test group (DBBM+HA)	Immediate Implant Placement	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.
Test group (DBBM+HA)	CTG placement	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.

Primary Outcome Measures

Name	Time	Method
Vertical buccal bone height changes (∆VBBH).	at baseline and at 6 months after procedure	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)

Secondary Outcome Measures

Name	Time	Method
Horizontal Buccal Bone Changes.	at baseline and at 6 months after treatment.	The horizontal linear distance between the outer surface of buccal bone at baseline and that at 6 months will be evaluated.
Handling of materials.	at the day of the surgery	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)
Width of keratinized tissue (KTW).	at baseline and at 6 months after treatment.	Measured at the buccal aspect, as the distance between gingival margin and mucogingival junction.
Osseous Ridge Width Changes.	at baseline and at 6 months after treatment.	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.
Amount of drug intake	from the day of surgery until day 14	The daily consumption of analgesics/anti-inflammatory medications from the day of surgery until day 14 will be calculated.
Soft tissue contour changes.	at baseline and at 6 months after treatment.	Linear and volumetric measurements will be performed using Stl files superimposition.
Wound healing index (WHI).	at 7 and 14 days after treatment.	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
Soft tissue thickness (STT).	at baseline and at 6 months after treatment.	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.
Post-surgical pain (PP)	at 7 and 14 days after treatment.	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).

Trial Locations

Locations (1)

Ospedale San Raffaele; 🇮🇹 Milan, Mi, Italy