Tunnel Access for Lateral Alveolar Ridge Augmentation

Not Applicable

Completed

• Conditions: Bone Loss; Implant Site Injury
• Interventions: Procedure: bone and soft tissue augmentation

• Registration Number: NCT05475730
• Lead Sponsor: D'Albis Dental

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-01-01
• Study First Submitted: 2022-01-15
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-27
• Status Verified: 2023-04
• Study Completion: 2023-04-01
• Last Update Submitted: 2023-04-29
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bone regeneration	bone and soft tissue augmentation	Minimally invasive horizontal bone augmentation using hyaluronic acid, deproteinized bovine bone and dermal matrix.

Primary Outcome Measures

Name	Time	Method
Augmented tissue volume	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.

Trial Locations

Locations (1)

Giuseppe D'Albis; 🇮🇹 Mola di Bari, Bari, Italy