Alveolar Ridge Preservation: Biologically-oriented Alveolar Ridge Preservation Vs Modified Periosteal Inhibition

NCT06784232 | Active Not Recruiting

• 1 other identifier: PERIOSTEAL INHIBITION
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The modified periosteal inhibition technique has been proposed as an alternative to limit crestal resorption following tooth extraction in sockets with a residual vestibular thickness of \<1 mm. This technique aims to prevent osteolytic activity on the external surface of a post-extraction socket by applying a 0.5 mm-thick soft cortical plate of porcine origin, secured with fibrin glue. By avoiding the placement of bone graft material inside the socket, the technique seeks to effectively counteract bone remodeling, achieving minimal reduction in the size of the alveolar crest. The aim is to evaluate the effectiveness of the modified periosteal inhibition technique in preserving the dimensions of the alveolar ridge after tooth extraction, by comparing it with the Biologically-oriented Alveolar Ridge Preservation technique.

Conditions

Alveolar Ridge Preservation; Alveolar Bone Loss

Outcome Measures

Primary Outcomes (2)

• ridge width reduction

  optical scanning comparison measured in millimetres at the mid-buccal and mid-palatal aspect of the socket

  26 weeks after tooth extraction and preservation tecnhique

• ridge height reduction

  optical scanning comparison measured in millimetres at the mid-buccal, mid-palatal, mesial and distal aspect of the socket

  26 weeks after tooth extraction and preservation tecnhique

Secondary Outcomes (3)

• histologic and histomorphometric analysis of new bone formation

  26 weeks after tooth extraction and preservation tecnhique

• histologic and histomorphometric analysis of residual graft particles

  26 weeks after tooth extraction and preservation tecnhique

• histologic and histomorphometric analysis of marrow spaces

  26 weeks after tooth extraction and preservation tecnhique

Study Arms (2)

BARP

collagen-bonegraft-collagen

Procedure: BARP

Modified Periosteal Inhibition Technique

cortical lamina, human fibrin glue and collagen

Procedure: Modified Periosteal Inhibition Technique

Interventions

BARP PROCEDURE

deep layers of collagen, medium-superficial heterologous bone graft, superficial collagen layer

BARP

Modified Periosteal Inhibition Technique PROCEDURE

Cortical lamina stabilized with human fibrin glue to preserve the buccal wall of the socket. The socket was then filled with collagen.

Modified Periosteal Inhibition Technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted in an outpatient hospital setting.

You may qualify if:

• Age between 18 and 80 years;
• Single-rooted tooth with indication for extraction with sockets having a residual thickness of \<1 mm in the first 3 mm of the buccal residual crest presenting adjacent teeth;
• American Society of Anesthesiologists 3;
• Periodontal health or stability;
• Signature of informed consent.

You may not qualify if:

• Presence of periapical cystic lesions at the intervention sites;
• Loss of bone tissue extending to the apical third on radiographic examination;
• Extraction of adjacent teeth within a period ranging from 6 months prior to 6 months after the extraction;
• Lack of one or more walls of the post-extraction socket;
• Presence of general contraindications for oral surgery;
• Presence of inflammatory and autoimmune diseases;
• Uncontrolled diabetes (HbA1c 7%);
• History of tumors requiring chemotherapy or radiotherapy in the last 5 years;
• Previous therapy with bisphosphonates or high-dose corticosteroid therapy;
• Smoking (10 cigarettes/day);
• Allergy to bovine collagen;
• Pregnancy or breastfeeding;
• Lack of compliance.

Sponsors & Collaborators

• International Piezosurgery Academy: lead
• University of Trieste: collaborator

Study Sites (1)

University of Trieste

Trieste, TS, 34127, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

alveolar bone specimens withdrawn with trephine bur

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)