Clinical trial NCT06275789: Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral: a Possible Solution for Alveolar Ridge Preservation?
Official title: Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral: a Possible Solution for Alveolar Ridge Preservation?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alveolar Ridge Preservation
Dental Extraction
Bone Graft
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: Geistlich Pharma AG
name: ZimVie
First posted: 2024-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: changes in horizontal dimensions of the alveolar ridge
timeFrame: 4 months
measure: changes in vertical dimensions of the alveolar ridge
timeFrame: 4 months
Secondary outcomes:
measure: vital bone percentage
timeFrame: 4 months
Other outcomes:
measure: thickness of the buccal plate in mm and its influence on the ridge dimension
timeFrame: 4 months
measure: the thickness of the lingual plate in mm and its influence on the ridge dimension
timeFrame: 4 months
measure: the thickness of the overlying buccal soft tissue in mm and its influence on the ridge dimension
timeFrame: 4 months
measure: the position of extraction site (maxilla vs. mandible) and its influence on the ridge dimension
timeFrame: 4 months
measure: # of cigarettes and its influence on the ridge dimension
timeFrame: 4 months
measure: oral hygiene using the plaque index and its influence on the ridge dimension
timeFrame: 4 months
Locations:
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University
state: Florida
Study officials:
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