Clinical trial NCT05475730: Tunnel Access for Lateral Alveolar Ridge Augmentation
Official title: Tunnel Access for Ridge Augmentation Using Xenogenous Bone, Hyaluronic Acid and Acellular Dermal Matrix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss
Implant Site Injury
Lead sponsor: D'Albis Dental
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 5
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Augmented tissue volume
timeFrame: 7 month
Secondary outcomes:
Other outcomes:
Locations:
city: Mola di Bari
country: Italy
facility: Giuseppe D'Albis
state: Bari
Study officials:
affiliation: D'Albis Dental
name: Giuseppe D'Albis
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.