Recruiting

Vallos®f & Bio-Oss

Sponsor:

University of Maryland, Baltimore

Code:

NCT06472453

Conditions

Alveolar Ridge Augmentation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Allograft/Xenograft

Allograft

Study Details

Brief summary:

This research aims to compare the effectiveness of two bone grafting materials on preserving jawbone integrity after tooth extraction. Following extraction, the jawbone surrounding the removed tooth can shrink, affecting future implant placement. By placing a bone graft material in the extraction socket, we aim to maintain adequate jawbone space for future implants. This study compares how well the mixture of vallos®f (human source bone) and Bio-Oss (animal source bone) \[test\], and vallos® only \[control\] grafting materials work.

Participants with at least one tooth planned for extraction and subsequent implant placement are sought for this study. Participants will be randomly assigned to either the mixture of vallos®f and Bio-Oss (test) group or the vallos® only (control) group.

Throughout the approximately 2-year study duration, participants will undergo oral exams, x-rays, surgical procedures, and follow-up visits. All participants will undergo routine tooth extraction, bone graft material placement, and dental implant placement. After the crown is placed on the implant, participants will attend follow-up visits.

Participation in the study is voluntary, and the alternative is to continue routine dental care. Risks include minor discomfort from procedures such as tooth extraction and implant placement. The major benefit of participation in the study is the preservation of jaw dimensions following extraction, which will simplify the placement of a dental implant.

Conditions

Alveolar Ridge Augmentation

Study ID

NCT06472453

Start date

Jan 13, 2025

Status verified date

Feb, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion criteria:

1. Provision of informed consent
2. At least 18 years old
3. In need of one posterior tooth (premolar or molar), excluding third molar molars, planned for extraction and replacement with a dental implant
4. Type I or II extraction socket/ ridge identified at the time of enrolment with cone-beam CT scan
5. At least one retained natural tooth adjacent to the study site

Exclusion criteria

1. Insufficient interocclusal or interdental space to allow for an implant- supported prosthesis
2. Previous interventions performed involving soft and/or bone grafting in the study site
3. Active treated caries
4. Uncontrolled periodontal disease present
5. Evidence of active periapical, radicular, or endodontic lesions on teeth adjacent to study site
6. History of recent extraction of an adjacent tooth (mesial and distal) to study site within 6 months of enrollment
7. Current smoker with self-reported history of more than 10 cigarettes or equivalent per day
8. Self-reported use of smokeless tobacco or e-cigarette
9. Self-reported history of current alcohol or drug abuse
10. Systemic or local disease or condition that would compromise bone metabolism, post-operative healing and/or osseointegration e.g. uncontrolled diabetes with self-reported most recent HbA1c > 8.0 within last six-month
11. Systemic corticosteroids or any other medication that would influence bone metabolism, post-operative healing, and/or osseointegration

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Alveolar ridge preservation with Allograft/Xenograft group

The patients in both groups will go through the same treatment but with two different bone grafting materials depending on the assigned group. The patients in this group will have alveolar ridge preservation with the mixture of demineralized cortical allograft vallos®f and xenograft bone substitute called Bio-Oss®.

active comparator: Alveolar ridge preservation with Allograft group

The patients in both groups will go through the same treatment but with two different bone grafting materials depending on the assigned group. The patients in this group will have alveolar ridge preservation with mineralized cortico-cancellous bone substitute called vallos®.

Interventions

Allograft/Xenograft

Alveolar ridge preservation of a single extraction socket site with a mixture of demineralized cortical bone substitute vallos®" and xenograft Bio-Oss®.

Allograft

Alveolar ridge preservation of a single extraction socket site with vallos® (mineralized cortico-cancellous bone substitute)

Primary outcome measure

  • Three-dimensional hard and soft tissue change using CBCT/ intraoral scan [ Time Frame: Over the course of the study (From the time of study enrollment Alveolar Ridge Preservation [Visit 2] to 1-year post implant-supported crown delivery [Visit 11]). ]

Central Contacts and Locations

Central contacts

Hanae Saito, DDS, MS, CCRC

410-706-3646hsaito@umaryland.edu

Locations

University of Maryland School of Dentistry

Recruiting

Baltimore, Maryland, United States, 21231

Contacts

Hanae Saito, DDS MS CCRC

410-706-3646hsaito@umaryland.edu

Principal Investigator:

Hanae Saito, DDS MS CCRC

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-02-10.