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

Alveolar Ridge Preservation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06275789
• Other study ID #: 2023-268
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Nova Southeastern University
• Contact: Andee Goldstein, DMD
• Phone: 7542599445
• Email: ag3577[@]mynsu.nova.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients in good health

• Require the extraction of at least one premolar 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%

• The tooth to be extracted must be bordered by two teeth

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

Related Conditions & MeSH terms

• Alveolar Ridge Preservation
• Bone Graft
• Dental Extraction

Intervention

Procedure:
• Alveolar ridge preservation
Premolar tooth will be extracted flapless and ridge preservation procedure with bone grafting material will be done.

Locations

Country	Name	City	State
United States	Nova Southeastern University	Fort Lauderdale	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Nova Southeastern University	Geistlich Pharma AG, ZimVie

Country where clinical trial is conducted

United States, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	thickness of the buccal plate in mm and its influence on the ridge dimension	the thickness of the buccal plate will be measured digitally to assess if it may be a confounding factor	4 months
Other	the thickness of the lingual plate in mm and its influence on the ridge dimension	the thickness of the lingual plate will be measured digitally to assess if it may be a confounding factor	4 months
Other	the thickness of the overlying buccal soft tissue in mm and its influence on the ridge dimension	the thickness of the overlying soft tissue will be measured digitally to assess if it may be a confounding factor	4 months
Other	the position of extraction site (maxilla vs. mandible) and its influence on the ridge dimension	the position of the tooth in the arch will be analyzed to assess if it may be a confounding factor	4 months
Other	# of cigarettes and its influence on the ridge dimension	the quantity of cigarettes will be analyzed to assess if it may be a confounding factor	4 months
Other	oral hygiene using the plaque index and its influence on the ridge dimension	the effectiveness of oral hygiene will be analyzed to assess if it may be a confounding factor	4 months
Primary	changes in horizontal dimensions of the alveolar ridge	Soft and hard tissue horizontal dimensions of the alveolar ridge will be measured after extraction and 4 months later.	4 months
Primary	changes in vertical dimensions of the alveolar ridge	Soft and hard tissue vertical dimensions of the alveolar ridge will be measured after extraction and 4 months later.	4 months
Secondary	vital bone percentage	vital bone percentage will evaluated histologically following biopsy at time of implant placement.	4 months