Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dentsply Sirona Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Dental implants are a fixed replacement solution with reported long-term survival rates between 94-98% over 20-40 years. In order to ensure successful implant therapy, adequate bone and soft tissue as well as correct 3D positioning of the implant are required. Upon extraction of a tooth, socket width can decrease by up to 60% within six months post-extraction, with a 11-22% vertical reduction. Additionally, sinus pneumatization occurs post-extraction as the maxillary sinus expands into the empty socket due to disuse atrophy and intra-sinus air pressure, as explained by Wolff's law. This further reduces residual bone height (RBH), often resulting in posterior maxillary sites requiring supplemental procedures to prevent bone loss or to augment the bone height at the time of implant placement. However, if the bone height and width dimensions are sufficient before and after extraction - in that, even with the aforementioned loss in width and height percentages in the latter, a standard implant may still be placed in the surrounding bone, one can argue that grafting may not be necessarily done at the time of extraction. Rather, it can be tailored to the patients' needs; thus potentially reducing overall post-operative discomfort and pain.
Bone grafting is a standard of care procedure often done several times during the course of therapy to ensure adequate surrounding bone to the implant. Alveolar ridge preservation (ARP) has emerged as an evidence-based and clinically validated approach for extraction site management, aiming to mitigate the dimensional bone and soft tissue loss that routinely follows tooth extraction. This is especially relevant in the posterior maxilla, where natural healing is often accompanied by significant reductions in both horizontal and vertical ridge dimensions. Oftentimes clinicians are faced with challenges intrasurgical that may lead to compromising the prosthetically driven implant position. Through thorough surgical planning prior to extraction, the investigators may be able to personalize bone grafting and surgical approaches in implant therapy, reduce the number of times the investigators graft while still achieving an ideal implant position, and improve the overall experience patients have. Careful preoperative analysis must be conducted to help guide clinicians in making these intraoperative decisions.
To address these limitations, this study leverages an interdisciplinary collaboration between the Departments of Periodontics and Prosthodontics at Virginia Commonwealth University (VCU). This team offers:
This multidisciplinary model ensures biologic ridge preservation, prosthetically guided treatment, and cost-effective, real-world application of ARP strategies.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Grafting | Other | Subject will receive immediate grafting using Ossix Plus (FDA approved resorbable cross-linked collagen membrane) and Ossix bone graft (FDA approved). All materials utilized in this study are commercially available, FDA-approved, used in standard of care procedures and commercially available by Dentsply Sirona. They will be used in accordance with the manufacturer's labeling and instructions. These materials are currently used for ARP and grafting in the VCU clinics. |
|
| Delayed Grafting | Other | Grafting will be performed after extraction and at the time of implant placement (T3, as referred to in the section on study timelines) using Ossix Agile® (FDA approved- resorbable collagen membrane), and Ossix bone graft (FDA approved). All materials utilized in this study are commercially available, FDA-approved, used in standard of care procedures and commercially available by Dentsply Sirona. They will be used in accordance with the manufacturer's labeling and instructions. These materials are currently used for ARP and grafting in the VCU clinics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ossix mineralized grafting immediately at extraction | Other | After surgical extraction, the socket is grafted using Ossix mineralized bone graft and covered with Ossix Plus membrane with standard suturing. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported outcomes (PROMs) and perception by using of Oral Health Impact Profile-14 (OHIP-14) | The OHIP-14 is a 14-question survey that measures how oral health problems affect a person's quality of life, assessing aspects like pain, discomfort, and limitations in daily activities across seven domains (functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap). A 5-point Likert scale is used for responses, and scores are summed (0-56). Higher scores indicate worse oral health impact. | Post-Implant: 2 week, 6 month and 1 year visits |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the clinical outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating bone thickness. | Measurements will be conducted using a caliper (mm) and periodontal probe (UNC probe in mm). | Post-Implant: 2 week, 6 month and 1 year visits |
Not provided
Inclusion Criteria:
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iya Ghassib | Contact | (804) 628-8376 | ghassibi@vcu.edu | |
| Tara Zhou | Contact | (804) 628-8376 | zhoutt@vcu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Iya Ghassib | Virginia Commonwealth University | Principal Investigator |
| Sandra Al-Tarawneh | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23298 | United States |
Not provided
| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
Not provided
Not provided
Randomized, parallel study with 2 arms (Immediate Grafting vs. Delayed Grafting)
Not provided
Not provided
No Masking. Subjects either receiving Immediate Grafting vs. Delayed Grafting.
Not provided
| Delayed grafting at implant placement | Other | Extraction sites heal without grafting. At implant placement (T3), augmentation-if needed based on ridge width or residual bone height-is performed using Ossix bone graft and Ossix Agile membrane. |
|
| To compare the clinical outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating soft tissue vertical thickness. |
Measurements will be conducted using a caliper (mm) and periodontal probe (UNC probe in mm). |
| Post-Implant: 2 week, 6 month and 1 year visits |
| To compare the clinical outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating soft tissue horizontal thicknesses. | Measurements will be conducted using a caliper (mm) and periodontal probe (UNC probe in mm). | Post-Implant: 2 week, 6 month and 1 year visits |
| To compare the radiographic outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating sinus pneumatization. | Radiographic outcomes will be measured through vertical and volumetric bone changes and sinus pneumatization assessed through pre- and post-operative CBCT (in mm) | Post-Implant: 2 week, 6 month and 1 year visits |
| To compare the radiographic outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating bone height. | Radiographic outcomes will be measured through vertical and volumetric bone changes and sinus pneumatization assessed through pre- and post-operative CBCT (in mm) | Post-Implant: 2 week, 6 month and 1 year visits |
| To compare the radiographic outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating bone width. | Radiographic outcomes will be measured through vertical and volumetric bone changes and sinus pneumatization assessed through pre- and post-operative CBCT (in mm) | Post-Implant: 2 week, 6 month and 1 year visits |
| To compare the radiographic outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating marginal bone levels. | Radiographic outcomes will be measured through vertical and volumetric bone changes and sinus pneumatization assessed through pre- and post-operative CBCT (in mm) | Post-Implant: 2 week, 6 month and 1 year visits |
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |