Clinical and Radiographic Evaluation of a Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials: a Multicentric Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Vertical buccal bone height changes (∆VBBH).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
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).
Eligibility Criteria
- Ages
- 22 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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%).
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Tooth Extraction (Procedure)
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.
Intervention: Immediate Implant Placement (Procedure)
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.
Intervention: Socket reconstruction with DBBB+HA (Procedure)
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.
Intervention: CTG placement (Procedure)
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.
Intervention: Tooth Extraction (Procedure)
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.
Intervention: Immediate Implant Placement (Procedure)
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.
Intervention: Socket reconstruction with DBBB (Procedure)
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.
Intervention: CTG placement (Procedure)
Outcomes
Primary Outcomes
Vertical buccal bone height changes (∆VBBH).
Time Frame: 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 Outcomes
- Amount of drug intake(from the day of surgery until day 14)
- Horizontal Buccal Bone Changes.(at baseline and at 6 months after treatment.)
- Handling of materials.(at the day of the surgery)
- Osseous Ridge Width Changes.(at baseline and at 6 months after treatment.)
- 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.)
- Wound healing index (WHI).(at 7 and 14 days after treatment.)
- Soft tissue thickness (STT).(at baseline and at 6 months after treatment.)
- Post-surgical pain (PP)(at 7 and 14 days after treatment.)
Investigators
Massimo de Sanctis
Professor
Università Vita-Salute San Raffaele