Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02532543
Other study ID # 15-1114
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date February 12, 2018

Study information

Verified date October 2019
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date February 12, 2018
Est. primary completion date February 12, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Allograft, Membrane
Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Alloplast, Membrane
Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Xenograft, Membrane
Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane
Membrane
Membrane - Symbios OsteoShield Collagen Resorbable Membrane

Locations

Country Name City State
United States University of North Carolina School of Dentistry Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Dentsply International

Country where clinical trial is conducted

United States, 

References & Publications (13)

Araújo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mean Osseous Dimensional Changes-Horizontal The amount of linear (mm) horizontal bone change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal plate. Data will be calculated using data from DICOM images acquired by CBCT using 3D software. time of extraction to 3 months post extraction
Secondary Mean Osseous Dimensional Changes-Vertical The amount of linear (mm) vertical bone change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from DICOM images acquired by CBCT using 3D software. time of extraction to 3 months post extraction
Secondary Total Mean Change in Soft Tissue Volume The change in soft tissue volume at 3 months following tooth extraction will be assessed through the use of 3D scans of patient dental models at two time points following extraction and ridge preservation at 3 months. time of extraction to 3 months post extraction
Secondary Mean Soft Tissue Dimensional Changes-Horizontal The amount of linear (mm) horizontal soft tissue change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal bone plate. Data will be calculated using data from DICOM images acquired by CBCT and overlaid 3D scans of patient dental models using 3D software. time of extraction to 3 months post extraction
Secondary Mean Soft Tissue Dimensional Changes-Vertical The amount of linear (mm) vertical soft tissue change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from 3D scans of patient dental models using 3D software. time of extraction to 3 months post extraction
Secondary Soft Tissue Dimensional Change at Month 6 The amount of soft tissue change will be assessed through the use of dental casts at two time points following extraction and ridge preservation at 6 months. Month 6
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05792800 - Dental Practitioners KAP Regarding Caries Preventive Measures in Cairo and Riyadah
Not yet recruiting NCT05792215 - KAP of Dental Practitioners Regarding CRA
Terminated NCT03871569 - Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home N/A
Active, not recruiting NCT04324008 - Clinical Comparison of Different Flowable Resin Composites N/A
Completed NCT02801552 - Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using PRF N/A
Completed NCT06112366 - Comparison of Silk Suture and Tissue Adhesive for Wound Closure After Impacted Tooth N/A
Recruiting NCT04033380 - Clinical Efficacy of Ceramic vs Resin Block Endocrown N/A
Completed NCT04003493 - LifE Style, Nutrition and Oral Health in Care Givers (LENTO) N/A
Completed NCT03708510 - Clinical Evaluation of Two Low-shrinkage Composites N/A
Completed NCT06067542 - Effects of Chlorhexidine Toothpaste on Wound Healing After Impacted Tooth Extraction N/A
Completed NCT03556553 - Clinical Evaluation of a Self-Adhering Flowable Composite in Class I Cavities N/A
Completed NCT04291443 - Proteomics and Orthodontic Root Resorption N/A
Completed NCT03553966 - Hydroxyapatite-toothpaste and Enamel Caries in the Primary Dentition N/A
Recruiting NCT01805869 - Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal
Completed NCT04385693 - Intentional Pulpotomy to Preserve Hopeless Molars N/A
Completed NCT02429947 - An Analysis of the Symptomatic Domains Most Relevant to Charcot Marie Tooth Neuropathy (CMT) Patients N/A
Recruiting NCT04029324 - Clinical Outcomes of Immediate Implant Placement and Early Implant Placement N/A
Recruiting NCT06212232 - A New Piezoelectric Technique in Third Molar Surgery N/A
Completed NCT04827693 - The Cortical Shield for Facial Bone Reconstruction
Completed NCT02868957 - Repetition Improves Precision and Trueness of Digital Intraoral Scans N/A