Tunnel Access for Horizontal Alveolar Ridge Augmentation

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 .

Study Overview

• Status: Completed
• Conditions: Bone Loss; Bone Resorption; Alveolar Bone Loss; Bone Atrophy, Alveolar; Alveolar Bone Resorption
• Intervention / Treatment: Procedure: Horizontal Ridge 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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • Giuseppe D'Albis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ridge augmentation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Bari Aldo Moro
• Investigators: Study Director: Professor Saverio Capodiferro, University of Bari Aldo Moro; Study Director: Professor Massimo Corsalini, University of Bari Aldo Moro; Principal Investigator: Dr. D'Albis Giuseppe, University of Bari Aldo Moro

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Bone augmentation; Ridge augmentation; Bone regeneration; Tissues augmentation
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Metabolic Diseases; Alveolar Bone Loss; Bone Resorption; Bone Diseases, Metabolic
• Other Study ID Numbers: Mini-invasiveRidgeAugmentation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No