Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06275789

Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral: a Possible Solution for Alveolar Ridge Preservation?

Led by Nova Southeastern University · Updated on 2025-09-12

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

Nova Southeastern University

Lead Sponsor

G

Geistlich Pharma AG

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new grafting material combining demineralized freeze-dried bone allograft (DFDBA) and deproteinized bovine bone mineral (DBBM) for alveolar ridge preservation after tooth extraction. The study aims to compare this new combination to a commonly used mineralized allograft, focusing on changes in ridge dimensions and bone quality. This research addresses the challenge of preserving bone volume and vitality for successful future dental implants. Participants who need a premolar or molar extraction followed by implant placement will be randomly assigned to one of two groups. One group will receive the new graft combination of DFDBA and DBBM with a collagen matrix seal, while the other group will receive the traditional Tutoplast4 processed mineralized particulate allograft with a collagen matrix seal. The procedures will be performed flaplessly during the alveolar ridge preservation process. Over a 4-month healing period, researchers will measure changes in the horizontal and vertical dimensions of the alveolar ridge and assess the percentage of vital bone formed. Participants will be monitored for these outcomes to evaluate the effectiveness of the graft materials. The study includes assessments of possible factors affecting ridge changes and will last approximately 4 months from treatment to evaluation.

CONDITIONS

Brief Title

Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral: a Possible Solution for Alveolar Ridge Preservation?

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients in good health
  • Require extraction of at least one premolar or molar with future implant placement
  • Have at least 2 mm of keratinized gingiva before extraction
  • Have no more than 3 mm of buccal bone loss
  • Flapless extraction is possible
  • Full mouth plaque index less than 25%
Not Eligible

You will not qualify if you...

  • Nicotine use equivalent to or more than 10 cigarettes per day
  • Use of electronic cigarettes
  • History of irradiation to head and neck area
  • Immunodeficiency disease
  • Uncontrolled systemic health problems such as hypertensive crisis, hyperthyroidism, uncontrolled diabetes (HbA1c over 7), recent stroke, or cancer
  • Use of medications affecting bone remodeling (e.g., bisphosphonates, RANK-L inhibitors)
  • Previous adverse reaction to graft materials used
  • Pregnancy, lactation, or trying to become pregnant
  • Active uncontrolled or untreated periodontal disease
  • Periapical lesions greater than 1 cm or soft tissue pathology

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single procedure with 4 months of healing

Participants undergo flapless extraction followed by alveolar ridge preservation using one of two bone grafting materials to minimize ridge dimensional changes.

1 treatment visit and follow-up assessments over 4 months

Follow-up

Duration - At 4 months post-treatment

Participants return for evaluation of alveolar ridge dimensions and bone histology after 4 months of healing.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Nova Southeastern University

Fort Lauderdale, Florida, United States, 33328

Actively Recruiting

Loading map...

Research Team

A

Andee Goldstein, DMD

F

Fatemeh Samavatijame, DMD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Using 2D/3D Imaging to Analyze Bone Regeneration During Alve...

Alveolar Ridge Preservation

Actively Recruiting

1 location

Clinical and Radiographic Evaluation of Allogenic Dentin Gra...

Alveolar Ridge Preservation

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study.

Lars Schropp, Ann Wenzel, Lambros Kostopoulos...

https://pubmed.ncbi.nlm.nih.gov/12956475

Consensus statements and recommended clinical procedures regarding the placement of implants in extraction sockets.

Christoph H F Hämmerle, Stephen T Chen, Thomas G Wilson

https://pubmed.ncbi.nlm.nih.gov/15635943

Effect of socket preservation therapies following tooth extraction in non-molar regions in humans: a systematic review.

J M A G Ten Heggeler, D E Slot, G A Van der Weijden

https://pubmed.ncbi.nlm.nih.gov/21091540

Ridge preservation in molar sites comparing xenograft versus mineralized freeze-dried bone allograft: A randomized clinical trial.

Desire Abellán, Lucía Barallat, Javi Vilarrasa...

https://pubmed.ncbi.nlm.nih.gov/35218248