Tunnel Access for Lateral Alveolar Ridge Augmentation

NCT ID: NCT05475730

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-04-01

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.

Conditions

Bone Loss; Implant Site Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Bone regeneration

Minimally invasive horizontal bone augmentation using hyaluronic acid, deproteinized bovine bone and dermal matrix.

Group Type: EXPERIMENTAL

bone and soft tissue augmentation

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Bone regeneration

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

D'Albis Dental

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe D'Albis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giuseppe D'Albis

Role: STUDY_DIRECTOR

D'Albis Dental

Locations

Giuseppe D'Albis

Mola di Bari, Bari, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 17912961 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32032406 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34547072 (View on PubMed)

Other Identifiers

2022

Identifier Type: -

Identifier Source: org_study_id