An Assessment of Bone Augmentation in Post-Extraction Sockets

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Study of Bone Augmentation Techniques in Extraction Sockets and Implant Surface Textures

Conditions
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Unrestorable Dentition, Post-Extraction Sockets

Intervention / Treatment
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* Procedure: AtraumaticTeeth Extraction
* Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets
* Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets
* Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Teeth extraction followed by natural healing | Procedure: AtraumaticTeeth Extraction<br>* Teeth extraction alone, allowed to heal for 2 months followed by implant therapy to the sites<br>* Other names: Post-extraction socket healing;|
| Experimental: 2- FDBA/TCP<br> | Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets<br>* 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<br>* Other names: Allograft;|
| Experimental: 3 FDBA/TCP+PRP<br> | Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets<br>* 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<br>* Other names: Platelet-rich plasma;|
| Experimental: 4 FDBA/TCP + PDGF<br> | Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets<br>* 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<br>* Other names: GEM-21;|

What is the study measuring?
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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 |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of dental implants |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Freeze-dried bone allograft, Platelet-rich plasma, Platelet-derived growth factors, Laser-threaded dental implants, Resorbable blast textured dental implants