Lamina Soft With Different Collagen Based Materials in Bone Regeneration (NCT07572643) | Clinical Trial Compass
CompletedNot Applicable
Lamina Soft With Different Collagen Based Materials in Bone Regeneration
Italy40 participantsStarted 2022-07-01
Plain-language summary
This prospective controlled clinical pilot study will compare the effectiveness of two different grafting strategies for horizontal bone regeneration in healed post-extraction sites with buccal bone deficiency, using a collagenated porcine cortical bone lamina as a barrier membrane.
A total of 21 patients requiring implant-supported rehabilitation associated with bone regeneration will be enrolled, for a total of 40 implants. In the test group, bone defects will be grafted using a collagenated cortico-cancellous sticky xenograft, while in the control group a mixture of hydroxyapatite-based xenograft and autologous bone in a 1:1 ratio will be used. In both groups, a semi-rigid collagenated cortical bone lamina will be applied and stabilized to contain the graft material and maintain space for regeneration.
The primary objective of the study will be to evaluate volumetric bone changes over time using cone-beam computed tomography imaging, comparing baseline and follow-up scans. Secondary outcomes will include linear measurements of bone gain at different levels around the implant site.
The study will investigate whether collagenated xenografts alone can provide comparable clinical and radiographic outcomes to combined grafting approaches including autologous bone, while potentially reducing patient morbidity associated with bone harvesting.
Who can participate
Age range
18 Years – 80 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:
* Healed type II post-extraction sockets according to the Elian classification
* Age between 18 and 80 years
* Good periodontal control, defined as treated periodontitis with plaque index \<25% and bleeding on probing \<25%
* ASA I or ASA II systemic status
* Ability and willingness to provide written informed consent
* Ability and willingness to attend scheduled follow-up visits
Exclusion Criteria:
* Smoking more than 10 cigarettes per day
* Active oral infections
* Mucosal diseases, including erosive lichen planus
* History of radiotherapy in the head and neck region
* Systemic diseases affecting bone metabolism or contraindicating oral surgery
* Non-compliance or inability to complete follow-up
* Extraction sockets with intact bone walls
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.