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

NCT06784232 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-12-01
Last updated
2025-01-22

Condition(s) studied

Alveolar Ridge PreservationAlveolar Bone Loss

Investigational drug(s) / intervention(s)

BARPModified Periosteal Inhibition Technique

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • ridge width reduction — 26 weeks after tooth extraction and preservation tecnhique
    optical scanning comparison measured in millimetres at the mid-buccal and mid-palatal aspect of the socket
  • ridge height reduction — 26 weeks after tooth extraction and preservation tecnhique
    optical scanning comparison measured in millimetres at the mid-buccal, mid-palatal, mesial and distal aspect of the socket

Trial sites (1)

FacilityCityRegionStatus
University of Trieste Trieste TS
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06784232 on ClinicalTrials.gov ↗ ← All trials in Italy