Menu
Recruiting NCT07433322

Alveolar Ridge Preservation (ARP) in the Posterior Maxilla After the Extraction of Maxillary Molars

No phase Interventional Alveolar Bone Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ossix mineralized grafting immediately at extraction, Delayed grafting at implant placement.
Who it may be relevant to
Registry conditions: Alveolar Bone Loss. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Alveolar Ridge Preservation (ARP) in the Posterior Maxilla: A Clinical and Economic Evaluation of ARP After the Extraction of Maxillary Molars

Overview

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

  • Other Ossix 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.
  • Other Delayed 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.

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT07433322 · HM300000021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗