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

NCT ID: NCT01105026

Last Updated: 2010-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-11-30

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.

Conditions

Alveolar Bone Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bioactive glass

Group Type: EXPERIMENTAL

Alveolar Bone Defect Regeneration Following Tooth Extraction

Intervention Type: 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.

Interventions

Alveolar 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inion Oy

INDUSTRY

Sponsor Role: collaborator

University of Trieste

OTHER

Sponsor Role: lead

Responsible Party

Division of Dental Sciences and Biomaterials, Department pf Biomedicine, University of Trieste, Trieste, Italy

References

Clozza E, Biasotto M, Cavalli F, Moimas L, Di Lenarda R. Three-dimensional evaluation of bone changes following ridge preservation procedures. Int J Oral Maxillofac Implants. 2012 Jul-Aug;27(4):770-5.

Reference Type: DERIVED

PMID: 22848877 (View on PubMed)

Clozza E, Pea M, Cavalli F, Moimas L, Di Lenarda R, Biasotto M. Healing of fresh extraction sockets filled with bioactive glass particles: histological findings in humans. Clin Implant Dent Relat Res. 2014 Feb;16(1):145-53. doi: 10.1111/j.1708-8208.2012.00463.x. Epub 2012 Jun 12.

Reference Type: DERIVED

PMID: 22691124 (View on PubMed)

Other Identifiers

CBT-109-CT

Identifier Type: -

Identifier Source: org_study_id