Tunnel Access for Lateral Alveolar Ridge Augmentation

NCT05475730 | Completed

• 1 other identifier: 2022
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Loss; Implant Site Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Bone regeneration

EXPERIMENTAL

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

Procedure: bone and soft tissue augmentation

Interventions

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.

Also known as: Bone regeneration

Bone regeneration

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• smoking of more than 15 cigarettes a day
• untreated periodontal disease
• acute infections
• keratinized mucosal tissue less than 2 mm.

Sponsors & Collaborators

• D'Albis Dental: lead

Study Sites (1)

Giuseppe D'Albis

Mola di Bari, Bari, 70042, Italy

Location

Related Publications (3)

• 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.

  PMID: 17912961 BACKGROUND

• 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.

  PMID: 32032406 RESULT

• 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.

  PMID: 34547072 RESULT

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Bone Regeneration

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Bone Remodeling; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Regeneration; Biological Phenomena

Study Officials

• Giuseppe D'Albis

  D'Albis Dental

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2022
• First Posted: July 27, 2022
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: April 1, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)