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Tunnel Access for Lateral Alveolar Ridge Augmentation

Tunnel Access for Ridge Augmentation Using Xenogenous Bone, Hyaluronic Acid and Acellular Dermal Matrix

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05475730
Enrollment
5
Registered
2022-07-27
Start date
2021-01-01
Completion date
2023-04-01
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Loss, Implant Site Injury

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 . performed by using a collagen dermal matrix, deproteinized bovine bone and hyaluronic acid. Collagen matrix is inserted into a sub-periosteal tunnel using microsurgical instruments. Deproteinized bovine bone in a hyaluronic acid carrier are placed and inserted repeatedly into the pocket and absorbable suture is used to close the vertical incision.

Detailed description

Tunnel bone regeneration achieves treatment objectives using the least invasive surgical approach.The goal is to increase patient satisfaction, decrease post-operative discomfort and morbidity.Preservation of the integrity of the periosteum is a determining factor in reducing postoperative pain and improving wound vascularization. The present study value the clinical results of a subperiosteal minimally invasive ridge horizontal augmentation technique. The technique includes the use of a laparoscopic approach to deliver hyaluronic acid,xenograft and a dermal matrix into a subperiosteal pouch.

Interventions

PROCEDUREbone and soft tissue 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 membrane and the mixed bone chips and hyaluronic acid are inserted into the tunnel until the desirable ridge dimensions are obtained. Primary closure of the vertical incisions was achieved with single interrupted sutures.

Sponsors

D'Albis Dental
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Augmented tissue volume7 monthThe edentulous ridge will be scanned with an intraoral scan 3 times. First time: Initial situation. Second time: 5 months after regeneration. Third time: After implant placement. Will be evaluate the 3 scan in a cad-cam software to evaluate the ridge three-dimensional changes.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026