Bone Loss Clinical Trial
Official title:
Tunnel Approach With Biphasic Calcium Phosphate and Acellular Dermal Matrix for Horizontal Ridge Augmentation.
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 .
Status | Not yet recruiting |
Enrollment | 5 |
Est. completion date | January 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients had to be healthy according to System of the American Society of Anesthesiology (ASA) and aged 18 years or older - No general medical condition representing a contraindication to implant therapy - minimum 2 missing teeth in the maxilla or mandible from the canine to the second molar - No periodontal disease (periodontal probing depth <4 mm) or treated periodontitis - Good oral hygiene (full mouth plaque index<25%) - Adequate control of inflammation (full mouth bleeding on probing<25%) Exclusion Criteria: - smoking of more than 15 cigarettes a day • untreated periodontal disease - pregnancy or breastfeeding at date of inclusion • acute infections - keratinized mucosal tissue less than 2 mm. |
Country | Name | City | State |
---|---|---|---|
Italy | Giuseppe D'Albis | Mola di Bari | Bari |
Lead Sponsor | Collaborator |
---|---|
University of Bari Aldo Moro |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
5 months | |
Secondary | 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. | 5 months |
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