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

September 5, 2025 updated by: Nova Southeastern University
The purpose of the study is to compare a new grafting material for alveolar ridge preservation to a commonly used and well studied material. Alveolar ridge dimensions as well as histology will be compared.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Brief Background and Goal: Dimensional changes following extractions are inevitable. Many techniques and combinations of materials have been studied and shown to be effective at minimizing these changes. Although no material has been able to fully preserve the ridge, xenografts have been shown to be the most effective at maintaining the volume, however, the use of demineralized freeze-dried bone allograft (DFDBA) results in the most vital bone when evaluated histologically. These factors are important when planning for a successful future implant supported prosthesis. A new material that combines xenograft (deproteinized bovine bone mineral - DBBM) with DFDBA has recently been introduced to the market. The aim of the study is to compare the dimensional and histological changes following flapless alveolar ridge preservation (ARP) in the premolar and molar region with a new material that combines DFDBA and DBBM to a commonly used mineralized allograft.

Research Question: In patients who require an extraction for future implant placement, during alveolar ridge preservation, will combining demineralized freeze-dried bone allograft (DFDBA) and deproteinized bovine bone mineral (DBBM) compared to Tutoplast® processed mineralized particulate allograft result in less dimensional changes at the time of implant placement 4 months later.

Specific Aims: The primary goal of the study is to compare the dimensional changes following alveolar ridge preservation with a new material that combines DFDBA and DBBM to a commonly used mineralized allograft material. The secondary goal is to assess the histological composition of the bone after 4 months of healing. The additional goals are to measure possible confounding factors on the dimensional changes of the alveolar ridge.

Significance: The goal behind the combination of DBBM and DFDBA is to evaluate whether there could potentially be a synergistic effect between the two materials that would make it a more desirable material to use for ARP procedures.

Innovation: There is currently no published research that compares the combination of DFDBA and DBBM to a conventional method inside the extraction site during an alveolar ridge preservation procedure. This grafting material is new on the market and the first of its kind.

Research Plan: The randomized clinical trial will be performed at the Nova Southeastern College of Dental Medicine in the Post-graduate Periodontology Clinic. 30 patients requiring premolar or molar extraction with future implant placement will be randomly divided into 2 groups, one test and one control. Following extraction, the patients will receive either allograft or graft combination of DFDBA and DBBM. The changes in horizontal and vertical dimensions of the alveolar ridge as well as the histology will be assessed and compared at 4 months.

Expected Results: When compared to allograft, the graft mixture containing the DFDBA and DBBM will maintain greater dimensional volume due to the dimensionally stable properties of DBBM and will contain more vital bone due to the osteoinductive properties of DFDBA.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33328
        • Recruiting
        • Nova Southeastern University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients in good health
  • Require the extraction of at least one premolar or molar with future implant placement
  • Sufficient keratinized gingiva (equal or more than 2mm prior to extraction),
  • No more than 3mm of buccal bone loss
  • Flapless extraction possible
  • Full mouth plaque index of less than 25%

Exclusion Criteria:

  • Nicotine consumption equivalent to or more than 10 cigarettes per day
  • Electronic cigarette usage
  • A history of irradiation of head and neck area
  • Immunodeficiency disease
  • Uncontrolled systemic health problems (hypertension crisis 180/120, hyperthyroidism, diabetes with HbA1c over 7, recent history of stroke, cancer) History of medications that affect bone remodeling process (bisphosphonates, RANK-L inhibitors)
  • Previous adverse reaction to the biomaterials used
  • Pregnancy/lactation, or those who are trying to become pregnant.
  • Active uncontrolled or untreated periodontal disease
  • Periapical lesions greater than 1 cm and soft tissue pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group
This group will receive the grafting material that is a combination of DFDBA + DBBM + collagen matrix seal during the alveolar ridge preservation procedure.
Procedure: Alveolar ridge preservation
Premolar tooth will be extracted flapless and ridge preservation procedure with bone grafting material will be done.
Active Comparator: Control Group
This group will receive the grafting material that is a Tutoplast® processed mineralized particulate allograft + collagen matrix seal during the alveolar ridge preservation procedure.
Procedure: Alveolar ridge preservation
Premolar tooth will be extracted flapless and ridge preservation procedure with bone grafting material will be done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in horizontal dimensions of the alveolar ridge
Time Frame: 4 months
Soft and hard tissue horizontal dimensions of the alveolar ridge will be measured after extraction and 4 months later.
4 months
changes in vertical dimensions of the alveolar ridge
Time Frame: 4 months
Soft and hard tissue vertical dimensions of the alveolar ridge will be measured after extraction and 4 months later.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vital bone percentage
Time Frame: 4 months
vital bone percentage will evaluated histologically following biopsy at time of implant placement.
4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
thickness of the buccal plate in mm and its influence on the ridge dimension
Time Frame: 4 months
the thickness of the buccal plate will be measured digitally to assess if it may be a confounding factor
4 months
the thickness of the lingual plate in mm and its influence on the ridge dimension
Time Frame: 4 months
the thickness of the lingual plate will be measured digitally to assess if it may be a confounding factor
4 months
# of cigarettes and its influence on the ridge dimension
Time Frame: 4 months
the quantity of cigarettes will be analyzed to assess if it may be a confounding factor
4 months
the thickness of the overlying buccal soft tissue in mm and its influence on the ridge dimension
Time Frame: 4 months, 1 year
the thickness of the overlying soft tissue will be measured digitally to assess if it may be a confounding factor
4 months, 1 year
the position of extraction site (maxilla vs. mandible) and its influence on the ridge dimension
Time Frame: 4 months, 1 year
the position of the tooth in the arch will be analyzed to assess if it may be a confounding factor
4 months, 1 year
oral hygiene using the plaque index and its influence on the ridge dimension
Time Frame: 4 months, 1 year
the effectiveness of oral hygiene will be analyzed to assess if it may be a confounding factor
4 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Southeastern University

Collaborators

Geistlich Pharma AG
ZimVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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