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

NCT02532543 | Terminated Results

• 1 other identifier: 15-1114
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Fractures; Tooth Injuries; Tooth Diseases

Outcome Measures

Primary Outcomes (1)

• Total Mean Change in Bone Volume

  The change in bone volume at 3 months following extraction will be calculated using data from DICOM images acquired by Cone Beam Computed Tomography (CBCT) using 3D software

  time of extraction to 3 months post extraction

Secondary Outcomes (6)

• Mean Osseous Dimensional Changes-Horizontal

  time of extraction to 3 months post extraction

• Mean Osseous Dimensional Changes-Vertical

  time of extraction to 3 months post extraction

• Total Mean Change in Soft Tissue Volume

  time of extraction to 3 months post extraction

• Mean Soft Tissue Dimensional Changes-Horizontal

  time of extraction to 3 months post extraction

• Mean Soft Tissue Dimensional Changes-Vertical

  time of extraction to 3 months post extraction

Study Arms (4)

Group A- Allograft, Membrane

ACTIVE COMPARATOR

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

Biological: Allograft, Membrane

Group B- Alloplast, Membrane

ACTIVE COMPARATOR

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

Biological: Alloplast, Membrane

Group C- Xenograft, Membrane

ACTIVE COMPARATOR

OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane

Biological: Xenograft, Membrane

Group D- Membrane

ACTIVE COMPARATOR

Symbios OsteoShield Collagen Resorbable Membrane

Biological: Membrane

Interventions

Allograft, Membrane BIOLOGICAL

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

Group A- Allograft, Membrane

Alloplast, Membrane BIOLOGICAL

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

Group B- Alloplast, Membrane

Xenograft, Membrane BIOLOGICAL

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

Group C- Xenograft, Membrane

Membrane BIOLOGICAL

Membrane - Symbios OsteoShield Collagen Resorbable Membrane

Group D- Membrane

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent
• ≥ 18 years and ≤ 75 years
• Good physical health (ASAI/II)
• Extraction of maxillary premolar, canine or incisor, or mandibular premolar and canine required
• 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

You may not qualify if:

• Buccal plate dehiscence and/or fenestration \>3mm at study site following extraction
• Untreated rampant caries and uncontrolled periodontal disease
• Inadequate oral hygiene (estimated plaque score \>20%)
• Smokers using more than 10 cigarettes or equivalent per day
• Smokeless tobacco use or e-cigarette use
• 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
• Systemic or local disease or condition that would compromise post-operative healing
• Use of any substance or medication that will influence bone metabolism
• Known pregnancy
• Unable or unwilling to return for follow-up visits for a period of 6 months
• Unlikely to be able to comply with study procedures according to Investigators judgement
• Involvement in the planning and conduct of the study
• Previous enrollment or randomization of treatment in the present study

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Dentsply International: collaborator

Study Sites (1)

University of North Carolina School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (13)

• 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.

  PMID: 12956475 BACKGROUND

• 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.

  PMID: 22211303 BACKGROUND

• 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.

  PMID: 15691354 BACKGROUND

• 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.

  PMID: 21091540 BACKGROUND

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

  PMID: 19885449 BACKGROUND

• 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.

  PMID: 21707753 BACKGROUND

• 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.

  PMID: 18384410 BACKGROUND

• 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.

  PMID: 20630297 BACKGROUND

• 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.

  PMID: 23513204 BACKGROUND

• 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.

  PMID: 21697155 BACKGROUND

• 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.

  PMID: 22668710 BACKGROUND

• 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.

  PMID: 23457068 BACKGROUND

• 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.

  PMID: 24155583 BACKGROUND

MeSH Terms

Conditions

Tooth Fractures; Tooth Injuries; Tooth Diseases

Interventions

Transplantation, Homologous; Transplantation, Heterologous

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: Gidgetta Kang
• Organization: University of North Carolina at Chapel Hill

gidgetta_jenkins@unc.edu

919-537-3968

Study Officials

• Jonathan Reside, DDS MS

  Dept. of Periodontology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 25, 2015
• Study Start: April 1, 2016
• Primary Completion: February 12, 2018
• Study Completion: February 12, 2018
• Last Updated: December 9, 2019
• Results First Posted: December 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)