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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07433322
Enrollment
40
Registered
2026-02-25
Start date
2026-06-18
Completion date
2028-04-01
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Loss

Keywords

Dental Implant, Alveolar Ridge Preservation (ARP), Maxilla

Brief summary

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.

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: 1. Coordinated surgical and prosthetic planning, 2. Integration of digital workflows for predictable implant positioning, 3. 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.

Interventions

OTHEROssix mineralized grafting immediately at extraction

After surgical extraction, the socket is grafted using Ossix mineralized bone graft and covered with Ossix Plus membrane with standard suturing.

OTHERDelayed grafting at implant placement

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.

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER
Dentsply Sirona Inc.
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Masking description

No Masking. Subjects either receiving Immediate Grafting vs. Delayed Grafting.

Intervention model description

Randomized, parallel study with 2 arms (Immediate Grafting vs. Delayed Grafting)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient reported outcomes (PROMs) and perception by using of Oral Health Impact Profile-14 (OHIP-14)Post-Implant: 2 week, 6 month and 1 year visitsThe 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.

Secondary

MeasureTime frameDescription
To compare the clinical outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating soft tissue horizontal thicknesses.Post-Implant: 2 week, 6 month and 1 year visitsMeasurements will be conducted using a caliper (mm) and periodontal probe (UNC probe in mm).
To compare the radiographic outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating sinus pneumatization.Post-Implant: 2 week, 6 month and 1 year visitsRadiographic outcomes will be measured through vertical and volumetric bone changes and sinus pneumatization assessed through pre- and post-operative CBCT (in mm)
To compare the radiographic outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating bone height.Post-Implant: 2 week, 6 month and 1 year visitsRadiographic outcomes will be measured through vertical and volumetric bone changes and sinus pneumatization assessed through pre- and post-operative CBCT (in mm)
To compare the radiographic outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating bone width.Post-Implant: 2 week, 6 month and 1 year visitsRadiographic outcomes will be measured through vertical and volumetric bone changes and sinus pneumatization assessed through pre- and post-operative CBCT (in mm)
To compare the radiographic outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating marginal bone levels.Post-Implant: 2 week, 6 month and 1 year visitsRadiographic outcomes will be measured through vertical and volumetric bone changes and sinus pneumatization assessed through pre- and post-operative CBCT (in mm)
To compare the clinical outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating soft tissue vertical thickness.Post-Implant: 2 week, 6 month and 1 year visitsMeasurements will be conducted using a caliper (mm) and periodontal probe (UNC probe in mm).
To compare the clinical outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating bone thickness.Post-Implant: 2 week, 6 month and 1 year visitsMeasurements will be conducted using a caliper (mm) and periodontal probe (UNC probe in mm).

Countries

United States

Contacts

CONTACTIya Ghassib
ghassibi@vcu.edu(804) 628-8376
CONTACTTara Zhou
zhoutt@vcu.edu(804) 628-8376
PRINCIPAL_INVESTIGATORIya Ghassib

Virginia Commonwealth University

PRINCIPAL_INVESTIGATORSandra Al-Tarawneh

Virginia Commonwealth University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026