Recruiting

Observational Study

Sponsor:

Virginia Commonwealth University

Code:

NCT07433322

Conditions

Alveolar Bone Loss

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ossix mineralized grafting immediately at extraction

Delayed grafting at implant placement

Study Details

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

Study ID

NCT07433322

Start date

Jun 18, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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 AgileĀ® (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.

Interventions

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.

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 measure

  • 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 ]

Central Contacts and Locations

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

Iya Ghassib

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Dental Implant
  • Alveolar Ridge Preservation (ARP)
  • Maxilla

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-08-20.