Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06472453

Vallomix Socket Preservation Study

Led by University of Maryland, Baltimore · Updated on 2026-02-10

24

Participants Needed

1

Research Sites

176 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Vallomix Socket Preservation Study

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide informed consent
  • Be at least 18 years old
  • Need extraction of one posterior tooth (premolar or molar, excluding third molars) with planned dental implant replacement
  • Have Type I or II extraction socket or ridge confirmed by cone-beam CT scan at enrollment
  • Have at least one natural tooth adjacent to the study site
Not Eligible

You will not qualify if you...

  • Insufficient space for implant-supported prosthesis at the study site
  • Previous bone or soft tissue grafting procedures at the study site
  • Active treated dental caries
  • Uncontrolled periodontal disease
  • Active periapical, radicular, or endodontic lesions on teeth next to the study site
  • Extraction of adjacent tooth within 6 months prior to enrollment
  • Current smoker of more than 10 cigarettes or equivalent per day
  • Use of smokeless tobacco or e-cigarettes
  • History of alcohol or drug abuse
  • Systemic or local diseases affecting bone metabolism or healing, including uncontrolled diabetes (HbA1c > 8.0 in last 6 months)
  • Use of systemic corticosteroids or medications affecting bone healing or implant integration

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Maryland School of Dentistry

Baltimore, Maryland, United States, 21231

Actively Recruiting

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Research Team

H

Hanae Saito, DDS, MS, CCRC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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