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NCT Number: NCT07433322

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

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.

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Key information

Conditions

Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location status: Recruiting

Location contact

Iya Ghassib

CONTACT

[email protected]

734-604-7960

Iya Ghassib

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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)

  5. 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)

  6. 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)

  7. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Iya Ghassib

CONTACT

[email protected]

(804) 628-8376

Tara Zhou

CONTACT

[email protected]

(804) 628-8376

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Dentsply Sirona Inc.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 25, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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