A Clinical Investigation to Evaluate the Healing of Tooth Extraction Sites Filled With BioRestore™

The aim of this study was to evaluate by histology and MSCT scans during a 7-month period, the efficacy of a bioactive glass (Inion BioRestore™) placed in human extraction sockets in the maintenance of alveolar ridge.

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Key information

Conditions

Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

14 subjects in need of implant therapy were enrolled in the study. A total of 32 teeth were extracted and the fresh sockets underwent to ridge preservation procedures using Inion BioRestore™. Two different time points (1 week and 3 months after RPP) MSCT scans for each patient were used as a basis for bone change analysis occurred in the localized grafted alveolar sites. Twenty-two biopsied, representative of intermediate (3-4 months, n=10) and late phase (6-7 months, n=12) of healing, were harvested and histologically analysed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Systemically healthy females or males subjects.
They did not smoke
Did not take any medications.

Exclusion criteria

Subjects with less than 18 years of age,
with current alcohol or drug abuse,
with systemic/local conditions that would interfere with wound healing or osseointegration
with a history of chemotherapy and radiotherapy in the head and neck region.

Treatment and study plan

Alveolar Bone Defect Regeneration Following Tooth Extraction

Device

Patients underwent surgery under local anesthesia and minimally invasive periotomy was carried out with a surgical blade. Atraumatic extraction with forceps was performed. The extraction socket was carefully curetted to remove the granulation tissue and was rinsed with a physiologic solution. To evaluate the eligibility of the surgical site, the alveolar walls integrity was checked clinically and by means of extemporaneous peri-apical radiography.

Then, the socket was filled to the bone margin with Inion BioRestore™ (granules size 1 to 2 millimetres). Finally, single interrupted (5-0) sutures were tightened to promote the stability of grafted particles. Ten days after the surgery, sutures were removed.

Sponsors and collaborators

Lead sponsor

University of Trieste

Other

Collaborators

Inion Oy

Registry information

Official study title

Bone Regeneration by Means of a Bioactive Glass Scaffold.

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Apr 16, 2010
Registry last updated: Apr 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed