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Clinical Trials/NCT05475730
NCT05475730
Completed
Not Applicable

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

D'Albis Dental1 site in 1 country5 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bone Loss
Sponsor
D'Albis Dental
Enrollment
5
Locations
1
Primary Endpoint
Augmented tissue volume
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
April 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
D'Albis Dental
Responsible Party
Principal Investigator
Principal Investigator

Giuseppe D'Albis

Principal Investigator

D'Albis Dental

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.

Outcomes

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.

Study Sites (1)

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