Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitut… (NCT06517030) | Clinical Trial Compass
RecruitingNot Applicable
Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials.
Italy30 participantsStarted 2025-04
Plain-language 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).
Who can participate
Age range
22 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vertical buccal bone height changes (∆VBBH).
Timeframe: at baseline and at 6 months after procedure
. 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.