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

NCT07433322 | Recruiting

• 1 other identifier: HM300000021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Loss

Keywords

Dental Implant; Alveolar Ridge Preservation (ARP); Maxilla

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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 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.

  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.

  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.

  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.

  Post-Implant: 2 week, 6 month and 1 year visits

Study Arms (2)

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.

Other: Ossix mineralized grafting immediately at extraction

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.

Other: Delayed grafting at implant placement

Interventions

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.

Immediate Grafting

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.

Delayed Grafting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Medically compromised
• heavy smokers
• young (\<18 yrs.) or those refusing treatment are excluded.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Dentsply Sirona Inc.: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Iya Ghassib

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Sandra Al-Tarawneh

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iya Ghassib

CONTACT

(804) 628-8376; ghassibi@vcu.edu

Tara Zhou

CONTACT

(804) 628-8376; zhoutt@vcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No Masking. Subjects either receiving Immediate Grafting vs. Delayed Grafting.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 25, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)