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

NCT06517030 | Recruiting

• 1 other identifier: Botiss-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Implant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Width of keratinized tissue (KTW).

  at baseline and at 6 months after treatment.

• Soft tissue contour changes.

  at baseline and at 6 months after treatment.

• Soft tissue thickness (STT).

  at baseline and at 6 months after treatment.

• Horizontal Buccal Bone Changes.

  at baseline and at 6 months after treatment.

• Osseous Ridge Width Changes.

  at baseline and at 6 months after treatment.

Study Arms (2)

Test group (DBBM+HA)

EXPERIMENTAL

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

Control group (DBBM)

ACTIVE COMPARATOR

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

Interventions

Tooth Extraction PROCEDURE

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

Control group (DBBM); Test group (DBBM+HA)

Immediate Implant Placement PROCEDURE

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.

Control group (DBBM); Test group (DBBM+HA)

Socket reconstruction with DBBB+HA PROCEDURE

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

Test group (DBBM+HA)

Socket reconstruction with DBBB PROCEDURE

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

Control group (DBBM)

CTG placement PROCEDURE

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); Test group (DBBM+HA)

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the trial.
• In good general health as evidenced by medical history.
• 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.
• Presence of \>3mm of buccal wall dehiscence evaluated using Cone Beam Computed Tomography (CBCT).
• 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%).

You may not qualify if:

• Current or previous use of immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
• Presence of inflammatory and autoimmune disease of the oral cavity.
• Severe or poorly controlled diabetes or previous radiotherapy of head area.
• Contraindications to dental and/or surgical interventions (e.g. severe endocrine bone diseases, severe metabolic bone disorders, malignant tumour diseases).
• Individuals who are smokers of \>10 cigarettes/day.
• Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
• Presence of \<3mm of dehiscence of buccal walls of the socket after tooth extraction.
• Presence of a distance between the interdental bone crest and buccal bone crest \<3 mm after tooth extraction.

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (1)

Ospedale San Raffaele

Milan, Mi, Italy

RECRUITING

MeSH Terms

Interventions

Tooth Extraction

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Central Study Contacts

Giovanna Laura Di Domenico

CONTACT

+393485826742; giovannalauradd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A randomization list will be generated in blocks: patients will be divided in 3 blocks according to the study center 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: July 24, 2024
• Study Start: April 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)