An Assessment of Bone Augmentation in Post-Extraction Sockets (FMD-007)
A Prospective Study of Bone Augmentation Techniques in Extraction Sockets and Implant Surface Textures
When a tooth is extracted the ridge of bone that held the tooth in place begins to heal and over time new bone grows to fill the empty space left by the missing tooth. Sometimes this process works very well and new bone grows to completely fill the socket, at other times new bone fails to fill in the space completely and patients are left with uneven bone-fill.
Grafted extraction sockets may fill with bone faster and more evenly than those without grafts, allowing the dentist to have greater control over the healing process and to repair the area with dental implants in a shorter period of time.
This study will help determine if grafting an extraction socket, with or without enriching the graft material, is an added benefit when compared to allowing the socket to heal naturally.
The study will also assess how well two different dental implant designs used to restore the area will function over time.
Study Overview
Status
Conditions
Detailed Description
Tooth extraction is often associated with resorption of the alveolar ridge height and width and with compromised soft tissue contours. A variety of methods have been proposed to overcome varied patterns of post-extraction healing.
An increasingly common practice combines skilled surgical technique with post-extraction site grafting utilizing both natural and synthetic bone-graft materials. These procedures are thought to retard resorption of the socket volume while lending some control over bone-fill - thereby preserving the integrity of the alveolar ridge for future reconstruction with dental implants.
Limited evidence-based data exist to support a variety of bone-graft materials including grafts enriched with autologous platelet-rich plasma(PRP)and grafts enriched with recombinant human platelet-derived growth factors(PDGF). Despite emerging clinical acceptance the most efficacious intervention remains undetermined.
In an effort to establish clinical evidence, this study will assess the efficacy of ridge preservation using three different bone grafting applications in post-extraction sockets compared to extraction alone.
The study will also asses longitudinal success of restoring the study sites with dental implants. Two innovative dental implant designs will be used in the study; an implant with a resorbable blast textured(RBT)surface and an implant with a laser thread-textured (LTT)surface.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35294 0007
- University of Alabama at Birmingham School of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Needed extraction of Maxillary and/or Mandibular Incisors and/or Pre-molar teeth
Exclusion Criteria:
- Inability to provide informed consent in English
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Teeth extraction followed by natural healing
|
Teeth extraction alone, allowed to heal for 2 months followed by implant therapy to the sites
Other Names:
|
|
Experimental: 2- FDBA/TCP
|
Teeth extraction/post-extraction socket grafting with Freeze-Dried Bone Allograft (FDBA) mixed with Tri-Calcium Phosphate(TCP) allowed to heal for 2 months followed by dental implant therapy to the sites
Other Names:
Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Autologous Platelet-Rich Plasma (PRP) allowed to heal for 2 months followed by dental implant therapy to the sites
Other Names:
Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Platelet-Derived Growth Factors (PDGF) allowed to heal for 2 months followed by dental implant therapy to the sites
Other Names:
|
|
Experimental: 3 FDBA/TCP+PRP
|
Teeth extraction/post-extraction socket grafting with Freeze-Dried Bone Allograft (FDBA) mixed with Tri-Calcium Phosphate(TCP) allowed to heal for 2 months followed by dental implant therapy to the sites
Other Names:
Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Autologous Platelet-Rich Plasma (PRP) allowed to heal for 2 months followed by dental implant therapy to the sites
Other Names:
Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Platelet-Derived Growth Factors (PDGF) allowed to heal for 2 months followed by dental implant therapy to the sites
Other Names:
|
|
Experimental: 4 FDBA/TCP + PDGF
|
Teeth extraction/post-extraction socket grafting with Freeze-Dried Bone Allograft (FDBA) mixed with Tri-Calcium Phosphate(TCP) allowed to heal for 2 months followed by dental implant therapy to the sites
Other Names:
Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Autologous Platelet-Rich Plasma (PRP) allowed to heal for 2 months followed by dental implant therapy to the sites
Other Names:
Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Platelet-Derived Growth Factors (PDGF) allowed to heal for 2 months followed by dental implant therapy to the sites
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone-fill in Grafted Post-extraction Sockets Versus Bone-fill in Non-grafted Post-extraction Sockets
Time Frame: 2 months
|
New bone formation in grafted extraction sockets to that of sites healed after 8 weeks of post-extraction.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Survival of dental implants
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nicolaas C Geurs, DDS, MS, University of Alabama at Birmingham
- Principal Investigator: Michael S Reddy, DMD, DMSc, University of Alabama at Birmingham
Publications and helpful links
General Publications
- Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.
- Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990.
- Artzi Z, Tal H, Dayan D. Porous bovine bone mineral in healing of human extraction sockets. Part 1: histomorphometric evaluations at 9 months. J Periodontol. 2000 Jun;71(6):1015-23. doi: 10.1902/jop.2000.71.6.1015.
- Lekovic V, Kenney EB, Weinlaender M, Han T, Klokkevold P, Nedic M, Orsini M. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. J Periodontol. 1997 Jun;68(6):563-70. doi: 10.1902/jop.1997.68.6.563.
- Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol. 2005 Dec;76(12):2205-15. doi: 10.1902/jop.2005.76.12.2205.
- Lekovic V, Camargo PM, Klokkevold PR, Weinlaender M, Kenney EB, Dimitrijevic B, Nedic M. Preservation of alveolar bone in extraction sockets using bioabsorbable membranes. J Periodontol. 1998 Sep;69(9):1044-9. doi: 10.1902/jop.1998.69.9.1044.
- Sclar AG. Strategies for management of single-tooth extraction sites in aesthetic implant therapy. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):90-105. doi: 10.1016/j.joms.2004.06.041. Erratum In: J Oral Maxillofac Surg. 2005 Jan;63(1):158.
- Artzi Z, Tal H, Dayan D. Porous bovine bone mineral in healing of human extraction sockets: 2. Histochemical observations at 9 months. J Periodontol. 2001 Feb;72(2):152-9. doi: 10.1902/jop.2001.72.2.152.
- Froum S, Cho SC, Rosenberg E, Rohrer M, Tarnow D. Histological comparison of healing extraction sockets implanted with bioactive glass or demineralized freeze-dried bone allograft: a pilot study. J Periodontol. 2002 Jan;73(1):94-102. doi: 10.1902/jop.2002.73.1.94.
- Zubillaga G, Von Hagen S, Simon BI, Deasy MJ. Changes in alveolar bone height and width following post-extraction ridge augmentation using a fixed bioabsorbable membrane and demineralized freeze-dried bone osteoinductive graft. J Periodontol. 2003 Jul;74(7):965-75. doi: 10.1902/jop.2003.74.7.965.
- Anitua E. Plasma rich in growth factors: preliminary results of use in the preparation of future sites for implants. Int J Oral Maxillofac Implants. 1999 Jul-Aug;14(4):529-35.
- Reddy M, Giannoble E, Nevins M, McGuire M. Kao R, Lynch S. Multicentered radiographic analysis of a regenerative medicine approach to periodontal bone destruction. Southeast Workshop on Tissue Engineering and Biomaterials 2nd Annual February 11-12, 2005
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- F071006001
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