Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials.
NCT ID: NCT06517030
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2025-04-30
2025-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement
NCT06182670
Osseodensification and Dental Implant Stability
NCT05376020
Randomized Controlled Trial of Full-Arch Rehabilitation
NCT01905306
Immediate Implant Outcomes With and Without Bone Augmentation
NCT05157009
Immediate Implant Placement in the Esthetic Zone
NCT01533571
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Test group (DBBM+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.
Tooth Extraction
After local anaesthesia, a buccal split-full-split-thickness envelope flap will be elevated, and the tooth will be extracted a-traumatically.
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.
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).
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.
Control group (DBBM)
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.
Tooth Extraction
After local anaesthesia, a buccal split-full-split-thickness envelope flap will be elevated, and the tooth will be extracted a-traumatically.
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.
Socket reconstruction with DBBB
The gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral (DBBM).
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tooth Extraction
After local anaesthesia, a buccal split-full-split-thickness envelope flap will be elevated, and the tooth will be extracted a-traumatically.
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.
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).
Socket reconstruction with DBBB
The gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral (DBBM).
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
22 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Università Vita-Salute San Raffaele
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Massimo de Sanctis
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ospedale San Raffaele
Milan, Mi, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Botiss-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.