Clinical trial NCT06424223: Tunnel Access for Horizontal Alveolar Ridge Augmentation
Official title: Tunnel Approach With Biphasic Calcium Phosphate and Acellular Dermal Matrix for Horizontal Ridge Augmentation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Atrophy, Alveolar
Bone Loss
Bone Resorption
Alveolar Bone Loss
Alveolar Bone Resorption
Keywords: Bone augmentation
Bone regeneration
Tissues augmentation
Ridge augmentation
Lead sponsor: University of Bari Aldo Moro
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 .

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the achievement of an adequate thickness of the alveolar ridge ridge
timeFrame: 5 months
Secondary outcomes:
measure: Histological analysis of newly formed tissues.
timeFrame: 5 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Giuseppe D'Albis
Study officials:
affiliation: University of Bari Aldo Moro
name: Professor Saverio Capodiferro
role: STUDY_DIRECTOR
affiliation: University of Bari Aldo Moro
name: Professor Massimo Corsalini
role: STUDY_DIRECTOR
affiliation: University of Bari Aldo Moro
name: Dr. D'Albis Giuseppe
role: PRINCIPAL_INVESTIGATOR
References: