Tunnel Access for Horizontal Alveolar Ridge Augmentation

NCT06424223 | Completed

• 1 other identifier: Mini-invasiveRidgeAugmentation
• 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 .

Conditions

Bone Atrophy, Alveolar; Bone Loss; Bone Resorption; Alveolar Bone Loss; Alveolar Bone Resorption

Keywords

Bone augmentation; Bone regeneration; Tissues augmentation; Ridge augmentation

Outcome Measures

Primary Outcomes (1)

• Evaluation of the achievement of an adequate thickness of the alveolar ridge ridge

  Digital intraoral casts will be superimposed to value the gained thickness of the ridge. The assessment of volume increase in the alveolar ridge will be observed within the implant planning software by measuring the variation in the width of the edentulous ridge by matching three scans. The scans will be conducted at baseline (T0), five months after ridge augmentation (T1), and two months after implant insertion (T2). The matching will be performed using corresponding pairs of regions. The thickness of the alveolar ridges on the same cross-section at the level of the implants inserted will be measured in mm using the "distance" tool.

  5 months

Secondary Outcomes (1)

• Histological analysis of newly formed tissues.

  5 months

Study Arms (1)

Ridge augmentation

EXPERIMENTAL

Procedure: Horizontal Ridge augmentation

Interventions

Horizontal Ridge 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 matrix and the Biphasic Calcium Phosphate is inserted into the tunnel until the desirable ridge dimensions are obtained. Primary closure of the vertical incisions was achieved with single interrupted sutures.

Ridge augmentation

Eligibility Criteria

• Age: 18 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
• keratinized mucosal tissue less than 2 mm.

Sponsors & Collaborators

• University of Bari Aldo Moro: lead

Study Sites (1)

Giuseppe D'Albis

Bari, 70124, Italy

Location

Related Publications (1)

• D'Albis G, Forte M, Marini L, Mustakim KR, Pilloni A, Corsalini M, Capodiferro S. Horizontal Ridge Augmentation with Xenogeneic Bone, Hyaluronic Acid, and Dermal Matrix by Tunnel Technique: A Case Series. Dent J (Basel). 2026 Jan 4;14(1):25. doi: 10.3390/dj14010025.

  PMID: 41590149 DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss; Bone Diseases, Metabolic; Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Professor Saverio Capodiferro

  University of Bari Aldo Moro

  STUDY DIRECTOR

• Professor Massimo Corsalini

  University of Bari Aldo Moro

  STUDY DIRECTOR

• Dr. D'Albis Giuseppe

  University of Bari Aldo Moro

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 22, 2024
• Study Start: November 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 3, 2025

Record last verified: 2024-12

Locations

IT (1)