Tunnel Access for Lateral Alveolar 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 .

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.

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Key information

Conditions

Bone Loss Bone Diseases Bone Diseases, Metabolic Implant Site Injury Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Giuseppe D'Albis

Mola di Bari, Bari, 70042, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bone and soft tissue augmentation

Procedure

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.

Other names: Bone regeneration

Primary outcomes

Augmented tissue volume

Time frame: 7 month

The 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.

Sponsors and collaborators

Lead sponsor

D'Albis Dental

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: Jul 27, 2022
Registry last updated: May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed