An interventional study of Horizontal Ridge augmentation in Bone Atrophy, Alveolar, Bone Loss and Bone Resorption, sponsored by University of Bari Aldo Moro. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-03.
Sponsored by University of Bari Aldo Moro · Not applicable, Interventional, and Treatment
Minimally invasive procedures with the tunnel technique have been suggested to decrease patient post-operative discomfort and morbidity in oral bone regeneration. In the ridge augmentation tunnel technique, crestal incision and the release of the connective tissue are avoided in order to enhance the blood supply of the flap. This approach preserves the blood circulation and does not damage the periosteum The purpose of this study is to evaluate the clinical outcome of a minimally invasive technique for maxillofacial horizontal bone augmentation .
Several techniques have been introduced to minimize the invasiveness involved in oral bone regeneration, to prevent the coronal advancement of the flap, which in turn reduces postoperative discomfort, swelling, complications, and mobility.
The tunnel technique involves making a vertical incision to access the bone defect and inserting the grafts. The significant benefit of this approach is that it may be closed without the need for periosteal incisions. Several tunnel techniques have been described in the literature using various biomaterials including bovine bone, synthetic bone, bovine bone block, allograft block bone, hidroxiapatite. This clinical study assesses the efficiency of a minimally invasive surgical technique for horizontal ridge augmentation using Biphasic Calcium Phosphate and Acellular Dermal Matrix.
This minimally invasive procedure aims to increase the horizontal volume of the edentulous ridge in both its bone component (through the use of Biphasic Calcium Phosphate) and its mucosal component (through the use of Acellular Dermal Matrix). Compared to other traditional techniques, this procedure, performed through a tunnel approach, would significantly reduce the invasiveness of the treatment.
Patients had to be healthy according to System of the American Society of Anesthesiology (ASA) and aged 18 years or older
Exclusion Criteria:
Procedure: Horizontal Ridge augmentation
A vertical full-thickness incision in the mesial aspect of the defect ridge.Microsurgery instruments is subsequently use to carefully elevate the full thickness of the mucosa. Extreme caution must be exercised during these maneuvers to avoid tissue perforation and to maintain the integrity of the periosteum.An dermal matrix is place into the tunnel. A pouch is create between the bone and the matrix and the Biphasic Calcium Phosphate is inserted into the tunnel until the desirable ridge dimensions are obtained. Primary closure of the vertical incisions was achieved with single interrupted sutures.
Evaluation of the achievement of an adequate thickness of the alveolar ridge ridge
Digital intraoral casts will be superimposed to value the gained thickness of the ridge. The assessment of volume increase in the alveolar ridge will be observed within the implant planning software by measuring the variation in the width of the edentulous ridge by matching three scans. The scans will be conducted at baseline (T0), five months after ridge augmentation (T1), and two months after implant insertion (T2). The matching will be performed using corresponding pairs of regions. The thickness of the alveolar ridges on the same cross-section at the level of the implants inserted will be measured in mm using the "distance" tool.
Time frame: 5 months
Histological analysis of newly formed tissues.
A histological analysis will be conducted by the pathology laboratory of the Bari University Hospital on a bone biopsy taken at the same time as the implant placement.
Time frame: 5 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Bari Aldo Moro