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

Bone Regeneration by Means of a Bioactive Glass Scaffold.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01105026

Enrollment

Registered

2010-04-16

Start date

2008-12-31

Completion date

2009-11-30

Last updated

2010-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Loss

Keywords

alveolar ridge preservation, bioactive glass, tooth extraction, graft material

Brief summary

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.

Detailed description

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.

Interventions

DEVICEAlveolar Bone Defect Regeneration Following Tooth Extraction

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026