Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia

Clinical and Histological Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00639860

Acronym

OSSIX

Enrollment

Registered

2008-03-20

Start date

2008-03-31

Completion date

2009-03-31

Last updated

2016-03-31

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

Conditions

Alveolar Bone Loss, Edentulous Alveolar Ridge, Loss of Teeth Due to Extraction

Keywords

extraction, implant, alveolar ridge preservation

Brief summary

The purpose of this study is to evaluate clinically, histologically and radiographically the healing of extraction sockets covered with a resorbable collagen membrane (OSSIX-Plus) 12 weeks following exodontia.

Detailed description

Reduction in alveolar ridge height and width may prohibit optimal implant placement, and often compromises the esthetic and functional result. Alveolar ridge preservation has been evaluated in many studies. A variety of bone grafting materials and barrier membranes have been studied for their ability to enhance bone formation in damaged alveolar ridges, and to evaluate their bone healing and bone-forming capacity in extraction sockets. However, the newly developed resorbable collagen membrane OSSIX-Plus has not been evaluated for this purpose. This study is designed to test the ability of OSSIX-Plus (OraPharma Inc., Warminster, Pennsylvania) in promoting optimal bone healing following exodontia. We hypothesize that use of OSSIX-Plus will result in preservation of the height, width and density of the residual alveolar ridge following tooth extraction.

Interventions

DEVICEOSSIX-Plus

resorbable collagen membrane

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Systemically healthy subjects with 1 maxillary premolar tooth requiring extraction * Residual extraction sockets must have \< 80% bone loss in all dimensions (3 or 4-walled bony defects) * Nonsmokers (individuals who quit smoking at least 6 months prior to the study will be allowed to participate) * Subjects willing and able to comply with all study-related procedures including maintenance of good oral hygiene and compliance with re-evaluation appointments * Subjects who read, understand and are willing to sign an informed consent statement

Exclusion criteria

* Inadequate zone of keratinized gingiva (KG) or alveolar mucosa to obtain primary wound closure of the surgical site * Presence of acute infections at the time of tooth extraction * Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth or other renal, hepatic, cardiac, endocrine, hematological, autoimmune or acute infectious diseases that makes interpretation of the data more difficult * History of head & neck radiation therapy * Subjects taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, biphosphonatesm, medications affecting bone turnover, antibiotics for \> 7 days or any investigational drug * Patients who are or become pregnant during the length of the study * Sites in which one or both adjacent teeth are missing

Design outcomes

Primary

Measure	Time frame	Description
Change in Bone Gain or Loss in Millimeters (Buccopalatal)	From Baseline to 12 weeks	Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Change in Bone Gain or Loss in Millimeters (Mesiodistal)	From Baseline to 12 weeks	Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Change in Bone Gain or Loss in Millimeters (Stent to Apex)	From Baseline to 12 weeks	Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Radiographic Bone Changes	From Baseline to 12 weeks	Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).
New Bone Formation	From Baseline to 12 weeks	Percentage of new bone formation of the alveolar bone core biopsies.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Placing OSSIX-Plus in Extraction Site Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. OSSIX-Plus: resorbable collagen membrane	10
Total	10

Baseline characteristics

Characteristic	Placing OSSIX-Plus in Extraction Site
Age, Customized	47.7 years
Region of Enrollment United States	10 participants
Sex: Female, Male Female	6 Participants
Sex: Female, Male Male	4 Participants
Socket width (buccopalatal)	8.3 mm
Socket width (meiodistal)	5.1 mm
Stent to apex of socket	16.5 mm
Stent to buccal plate	5.6 mm
Stent to distal osseous crest	4.1 mm
Stent to mesial osseous crest	4.0 mm
Stent to midosseous crest	4.7 mm

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 10
serious Total, serious adverse events	0 / 10

Outcome results

Primary

Change in Bone Gain or Loss in Millimeters (Buccopalatal)

Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.