Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06472453

Prospective Comparative Evaluation of Alveolar Ridge Preservation Using a Mixture of Allograft and Xenograft Versus Allograft Alone in Tooth Extraction Sockets

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

24

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare how well two different bone grafting materials preserve jawbone shape after tooth extraction. The jawbone can shrink following tooth removal, which may affect future dental implant placement. The study evaluates a mixture of vallosëf (human bone) and Bio-Oss (animal bone) against vallosë alone to see which better maintains jawbone space for implants. Participants will have at least one tooth removed and will be randomly assigned to receive either the mixture of vallosëf and Bio-Oss or vallosë alone as the grafting material. Both groups undergo similar procedures including tooth extraction, placement of the bone graft in the socket, and later dental implant placement. After the implant crown is placed, participants continue with follow-up visits. During this approximately 2-year study, participants will have oral exams, x-rays, and surgical procedures. Researchers will measure changes in hard and soft tissue using 3D scans from enrollment to one year after the implant crown is delivered. Additional comparisons include implant positioning and bone analysis at implant placement. Participants’ jawbone preservation and implant outcomes will be closely monitored along with safety and healing.

CONDITIONS

Brief 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) planned for implant replacement
  • Have a Type I or II extraction socket identified by cone-beam CT scan at enrollment
  • Have at least one natural tooth next to the extraction site
Not Eligible

You will not qualify if you...

  • Insufficient space for an implant-supported prosthesis
  • Previous soft or bone grafting at the study site
  • Active treated tooth decay
  • Uncontrolled gum disease
  • Active infection or lesions on teeth next to the study site
  • Recent extraction of an adjacent tooth within 6 months
  • Current smoker of more than 10 cigarettes per day
  • Use of smokeless tobacco or e-cigarettes
  • Current alcohol or drug abuse
  • Health conditions affecting bone healing like uncontrolled diabetes with high HbA1c
  • Use of corticosteroids or medications affecting bone metabolism or healing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 day

Participants undergo alveolar ridge preservation of a single extraction socket site using either a mixture of allograft and xenograft or allograft alone depending on their assigned group.

1 visit (in-person)

Post-operative Follow-up

Duration - Up to 5 months

Participants are monitored for healing and changes in hard and soft tissue after alveolar ridge preservation.

Multiple follow-up visits up to 5 months including implant placement visit

Follow-up

Duration - Up to 1 year

Participants are followed for up to 1 year after implant-supported crown delivery to evaluate long-term tissue changes.

Periodic visits up to 1 year post implant-supported crown delivery

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

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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