- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433322
Alveolar Ridge Preservation (ARP) in the Posterior Maxilla After the Extraction of Maxillary Molars
Alveolar Ridge Preservation (ARP) in the Posterior Maxilla: A Clinical and Economic Evaluation of ARP After the Extraction of Maxillary Molars
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- Coordinated surgical and prosthetic planning,
- Integration of digital workflows for predictable implant positioning,
- Comprehensive follow-up and patient retention in a controlled academic environment.
This multidisciplinary model ensures biologic ridge preservation, prosthetically guided treatment, and cost-effective, real-world application of ARP strategies.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Iya Ghassib
- Phone Number: (804) 628-8376
- Email: ghassibi@vcu.edu
Study Contact Backup
- Name: Tara Zhou
- Phone Number: (804) 628-8376
- Email: zhoutt@vcu.edu
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University
-
Contact:
- Iya Ghassib
- Phone Number: 734-604-7960
- Email: ghassibi@vcu.edu
-
Principal Investigator:
- Iya Ghassib
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Intact or <5mm dehiscence buccally and palatally
- Initial residual bone height (RBH) of at least 6 mm. 3-A minimum distance of 1 mm between root apices and sinus membrane.
Exclusion Criteria
- Medically compromised
- heavy smokers
- young (<18 yrs.) or those refusing treatment are excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Immediate Grafting
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. |
After surgical extraction, the socket is grafted using Ossix mineralized bone graft and covered with Ossix Plus membrane with standard suturing.
|
|
Other: Delayed Grafting
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient reported outcomes (PROMs) and perception by using of Oral Health Impact Profile-14 (OHIP-14)
Time Frame: Post-Implant: 2 week, 6 month and 1 year visits
|
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
|
Secondary Outcome Measures
Outcome Measure |
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.
Time Frame: Post-Implant: 2 week, 6 month and 1 year visits
|
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 vertical thickness.
Time Frame: Post-Implant: 2 week, 6 month and 1 year visits
|
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.
Time Frame: Post-Implant: 2 week, 6 month and 1 year visits
|
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.
Time Frame: Post-Implant: 2 week, 6 month and 1 year visits
|
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.
Time Frame: Post-Implant: 2 week, 6 month and 1 year visits
|
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.
Time Frame: Post-Implant: 2 week, 6 month and 1 year visits
|
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.
Time Frame: Post-Implant: 2 week, 6 month and 1 year visits
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Iya Ghassib, Virginia Commonwealth University
- Principal Investigator: Sandra Al-Tarawneh, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM300000021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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