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Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials

NCT ID: NCT02532543

Last Updated: 2019-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-02-12

Brief Summary

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This study is intended to provide statistically robust evidence that Symbios Demineralized Cortical-cancellous granule mix, Symbios OsteoGraf LD-300, and OsteoGraf/N-300 combined with Symbios OsteoShield Collagen Resorbable Membrane can adequately support the alveolus during ridge augmentation procedures, reducing the dimensional changes of both the alveolus and the overlying soft tissues. Additionally, a comparison between each material will be made, providing further evidence of each materials' ability to preserve the alveolus. It is intended to define in objective terms the response of the hard and soft tissues to ridge augmentation.

Detailed Description

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Conditions

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Tooth Fractures Tooth Injuries Tooth Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A- Allograft, Membrane

Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane

Group Type ACTIVE_COMPARATOR

Allograft, Membrane

Intervention Type BIOLOGICAL

Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane

Group B- Alloplast, Membrane

Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane

Group Type ACTIVE_COMPARATOR

Alloplast, Membrane

Intervention Type BIOLOGICAL

Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane

Group C- Xenograft, Membrane

OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane

Group Type ACTIVE_COMPARATOR

Xenograft, Membrane

Intervention Type BIOLOGICAL

Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane

Group D- Membrane

Symbios OsteoShield Collagen Resorbable Membrane

Group Type ACTIVE_COMPARATOR

Membrane

Intervention Type BIOLOGICAL

Membrane - Symbios OsteoShield Collagen Resorbable Membrane

Interventions

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Allograft, Membrane

Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane

Intervention Type BIOLOGICAL

Alloplast, Membrane

Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane

Intervention Type BIOLOGICAL

Xenograft, Membrane

Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane

Intervention Type BIOLOGICAL

Membrane

Membrane - Symbios OsteoShield Collagen Resorbable Membrane

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Provision of informed consent
2. ≥ 18 years and ≤ 75 years
3. Good physical health (ASAI/II)
4. Extraction of maxillary premolar, canine or incisor, or mandibular premolar and canine required
5. Teeth adjacent (mesial and distal) to study site must consist of two stable natural teeth with minimal restorations, without signs of periodontal bone loss (\> 3 mm) and/or significant soft tissue deficiencies

Exclusion Criteria

1. Buccal plate dehiscence and/or fenestration \>3mm at study site following extraction
2. Untreated rampant caries and uncontrolled periodontal disease
3. Inadequate oral hygiene (estimated plaque score \>20%)
4. Smokers using more than 10 cigarettes or equivalent per day
5. Smokeless tobacco use or e-cigarette use
6. Compromised physical health and/or uncontrolled or severe systemic diseases including:

ASA III/IV Metabolic bone disease History of malignancy History or radiotherapy or chemotherapy for malignancy in the past 5 years History of autoimmune disease Long-term steroidal or antibiotic therapy Uncontrolled diabetes Known alcohol or drug abuse
7. Systemic or local disease or condition that would compromise post-operative healing
8. Use of any substance or medication that will influence bone metabolism
9. Known pregnancy
10. Unable or unwilling to return for follow-up visits for a period of 6 months
11. Unlikely to be able to comply with study procedures according to Investigators judgement
12. Involvement in the planning and conduct of the study
13. Previous enrollment or randomization of treatment in the present study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dentsply International

INDUSTRY

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Reside, DDS MS

Role: PRINCIPAL_INVESTIGATOR

Dept. of Periodontology

Locations

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University of North Carolina School of Dentistry

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.

Reference Type BACKGROUND
PMID: 12956475 (View on PubMed)

Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.

Reference Type BACKGROUND
PMID: 22211303 (View on PubMed)

Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.

Reference Type BACKGROUND
PMID: 15691354 (View on PubMed)

Ten Heggeler JM, Slot DE, Van der Weijden GA. Effect of socket preservation therapies following tooth extraction in non-molar regions in humans: a systematic review. Clin Oral Implants Res. 2011 Aug;22(8):779-88. doi: 10.1111/j.1600-0501.2010.02064.x. Epub 2010 Nov 22.

Reference Type BACKGROUND
PMID: 21091540 (View on PubMed)

Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71.

Reference Type BACKGROUND
PMID: 19885449 (View on PubMed)

Fienitz T, Schwarz F, Ritter L, Dreiseidler T, Becker J, Rothamel D. Accuracy of cone beam computed tomography in assessing peri-implant bone defect regeneration: a histologically controlled study in dogs. Clin Oral Implants Res. 2012 Jul;23(7):882-7. doi: 10.1111/j.1600-0501.2011.02232.x. Epub 2011 Jun 24.

Reference Type BACKGROUND
PMID: 21707753 (View on PubMed)

Veyre-Goulet S, Fortin T, Thierry A. Accuracy of linear measurement provided by cone beam computed tomography to assess bone quantity in the posterior maxilla: a human cadaver study. Clin Implant Dent Relat Res. 2008 Dec;10(4):226-30. doi: 10.1111/j.1708-8208.2008.00083.x. Epub 2008 Apr 1.

Reference Type BACKGROUND
PMID: 18384410 (View on PubMed)

Kim TS, Caruso JM, Christensen H, Torabinejad M. A comparison of cone-beam computed tomography and direct measurement in the examination of the mandibular canal and adjacent structures. J Endod. 2010 Jul;36(7):1191-4. doi: 10.1016/j.joen.2010.03.028.

Reference Type BACKGROUND
PMID: 20630297 (View on PubMed)

Pertl L, Gashi-Cenkoglu B, Reichmann J, Jakse N, Pertl C. Preoperative assessment of the mandibular canal in implant surgery: comparison of rotational panoramic radiography (OPG), computed tomography (CT) and cone beam computed tomography (CBCT) for preoperative assessment in implant surgery. Eur J Oral Implantol. 2013 Spring;6(1):73-80.

Reference Type BACKGROUND
PMID: 23513204 (View on PubMed)

Ganguly R, Ruprecht A, Vincent S, Hellstein J, Timmons S, Qian F. Accuracy of linear measurement in the Galileos cone beam computed tomography under simulated clinical conditions. Dentomaxillofac Radiol. 2011 Jul;40(5):299-305. doi: 10.1259/dmfr/72117593.

Reference Type BACKGROUND
PMID: 21697155 (View on PubMed)

Tyndall DA, Price JB, Tetradis S, Ganz SD, Hildebolt C, Scarfe WC; American Academy of Oral and Maxillofacial Radiology. Position statement of the American Academy of Oral and Maxillofacial Radiology on selection criteria for the use of radiology in dental implantology with emphasis on cone beam computed tomography. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Jun;113(6):817-26. doi: 10.1016/j.oooo.2012.03.005.

Reference Type BACKGROUND
PMID: 22668710 (View on PubMed)

Watters W 3rd, Rethman MP, Hanson NB, Abt E, Anderson PA, Carroll KC, Futrell HC, Garvin K, Glenn SO, Hellstein J, Hewlett A, Kolessar D, Moucha C, O'Donnell RJ, O'Toole JE, Osmon DR, Evans RP, Rinella A, Steinberg MJ, Goldberg M, Ristic H, Boyer K, Sluka P, Martin WR 3rd, Cummins DS, Song S, Woznica A, Gross L; American Academy of Orthopedic Surgeons; American Dental Association. Prevention of Orthopaedic Implant Infection in Patients Undergoing Dental Procedures. J Am Acad Orthop Surg. 2013 Mar;21(3):180-9. doi: 10.5435/JAAOS-21-03-180.

Reference Type BACKGROUND
PMID: 23457068 (View on PubMed)

Kurien S, Kattimani VS, Sriram RR, Sriram SK, Rao V K P, Bhupathi A, Bodduru RR, N Patil N. Management of pregnant patient in dentistry. J Int Oral Health. 2013 Feb;5(1):88-97. Epub 2013 Feb 26.

Reference Type BACKGROUND
PMID: 24155583 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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15-1114

Identifier Type: -

Identifier Source: org_study_id