Tunnel Access for Lateral Alveolar Ridge Augmentation

Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05475730
• Other study ID #: 2022
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: April 2023
• Source: D'Albis Dental
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Loss

Intervention

Procedure:
• bone 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.

Locations

Country	Name	City	State
Italy	Giuseppe D'Albis	Mola di Bari	Bari

Sponsors (1)

Lead Sponsor	Collaborator
D'Albis Dental

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Karmon B, Tavelli L, Rasperini G. Tunnel Technique with a Subperiosteal Bag for Horizontal Ridge Augmentation. Int J Periodontics Restorative Dent. 2020 Mar/Apr;40(2):223-230. doi: 10.11607/prd.4508. — View Citation

Kfir E, Kfir V, Eliav E, Kaluski E. Minimally invasive guided bone regeneration. J Oral Implantol. 2007;33(4):205-10. doi: 10.1563/1548-1336(2007)33[205:MIGBR]2.0.CO;2. — View Citation

Rasperini G, Tavelli L, Barootchi S, Karmon B. Tunnel Technique with a Subperiosteal Bag for Ridge Augmentation: A Case Series. Int J Periodontics Restorative Dent. 2021 Sep-Oct;41(5):693-700. doi: 10.11607/prd.5136. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Augmented tissue volume	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.	7 month