Clinical trial NCT06722482: Comparison of Two Types of Bone Grafts in Patients Who Need One of Their Front Teeth Removed and Replaced With an Implant
Official title: Clinical Evaluation of Freeze-Dried Bone Allograft Compared to Collagen-Enriched Bovine Xenograft for Alveolar Ridge Preservation of Anterior Extraction Sockets.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ridge Preservation
Allografts
Extraction, Tooth
Xenograft
Keywords: alveolar ridge preservation
tooth extraction
freeze-dried bone allograft
collagen-enriched bovine xenograft
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Implant Dentistry Research & Education Foundation (IDREF)
First posted: 2024-12-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single center, pilot, randomized, clinical trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two different bone graft materials (freeze-dried bone allograft, FDBA and collagen-enriched bovine xenograft, CEBX) that are routinely used for preserving the remaining bone after extraction of an anterior tooth, and before placing a dental implant. Patients will be randomly assigned to either group (flip of a coin) One group will receive FDBA material and the other group will receive CEBX (cow) material.

The study aims to examine the following main questions:

* Potential differences in linear radiographic horizontal (HRD) and vertical (VRD) ridge dimensional changes between groups after 16 weeks of healing
* Other clinical information of the treated areas and information regarding the esthetics of the dental implant that will subsequently be placed at the edentulous site as well as patient satisfaction with the treatment, will be evaluated.

The study will include 7 study visits. Study procedures will take place during the same visits as the standard of care treatments (tooth extraction and bone graft, dental implant placement, crown installation and follow-ups). Clinical information from these standard of care visits will be used for the current research study, such as:

* Demographic information
* Clinical information from intraoral photographs
* Radiographic information from cone beam computed tomography and periapical radiographs.

Detailed description: The study will compare clinical, radiographic (dental cone beam computed tomography) and histologic outcomes upon tooth extraction and alveolar ridge preservation (ARP) as well as clinical, radiographic and patient-reported outcomes upon implant placement and crown fabrication at the same site.

Both bone graft materials (FDBA and CEBX) are FDA approved and are widely available in the US market and are routinely used in everyday practices and within the university.

* FDBA is produced by Community Blood Center (Community Tissue Services, Ohio, USA) (FEI: 3008808182).
* CEBX is produced by Geistlich Pharma AG (Wolhusen, Switzerland) \[501(k) #: K122894\].

Both materials will be stored and utilized based on manufacturers' recommendations and as per of Standard of Care protocols within the university.

Participants and investigators will be unaware of the envelope content and each participant will be asked to randomly pick an envelope and immediately both the participant as well as the investigator will be informed about the envelope content and, therefore, the group allocation. Eventually, participants and investigators will be aware of the group allocation, except for the investigator who will conduct all the study measurements who will remain blinded.

Upon healing, both groups will receive similar treatment as far as implant placement and crown restoration is concerned.

Interventions and procedures

The study-related interventions and procedures will more specifically include:

1. Evaluation of horizontal and vertical ridge dimensional changes as well as contour changes upon standard of care procedures (alveolar ridge preservation) through cone beam computed tomography and intraoral scanning, respectively, after 16 weeks of healing.
2. Determination of the feasibility of prosthetically driven implant placement upon standard of care evaluation of the post-healing cone beam computed tomography, at 16 weeks after ARP.
3. Histological evaluation of the healed grafted area upon grafting with frequently used bone graft materials at 16 weeks of healing.
4. Assessment of peri-implant clinical and radiographic parameters as well as crown esthetics and patient satisfaction upon 12 months from the dental implant placement.

Eligibility criteria: Inclusion Criteria:

* patients able to provide informed consent
* patients of 18 years of age or older at time of consent and enrollment
* patients in need of at least one anterior tooth extraction and seeking dental implant replacement
* bone on the buccal of the central/lateral incisors or canines planned for extraction that is either intact or has a dehiscence \</=5mm as determined radiographically through cone beam computed tomography (CBCT)

Exclusion Criteria:

* current smokers or tobacco-product users (self-reported)
* uncontrolled diabetes (HbA1c≥7 in the last 3 months)
* pregnant and/or lactating females (self-reported)
* patients on immunosuppressants, steroids, bisphosphonates or other medications that have been related to Medication-Related Osteonecrosis of the Jaw (MRONJ) as described by the American Association of Oral Maxillofacial Surgeons (AAOMS) 2014 update
* patients with history of radiation of the head and neck
* patients with allergy to collagen, bacitracin and/or polymyxin B
* patients with religious or cultural beliefs that prohibit the use of either allograft or bovine graft material
* patients with physical and/or mental/cognitive disabilities (self-reported) or decisionally-impaired, not able to consent for themselves
* patients with untreated periodontitis
* patients with central/lateral incisors or canines requiring extraction and are adjacent to an edentulous area
* patients with central/lateral incisors or canines with buccal bone dehiscence \>5mm

Primary outcomes:
measure: Mean change in radiographic horizontal and vertical ridge dimensions
timeFrame: baseline to 16 weeks after surgery
Secondary outcomes:
measure: Mean change in alveolar ridge contour
timeFrame: baseline to 4 weeks after surgery
measure: Mean change in alveolar ridge contour
timeFrame: baseline to 2 months after implant placement, approximately 24 weeks
measure: Mean change in alveolar ridge contour
timeFrame: baseline to 12 months after implant placement, approximately 70 weeks
measure: Number of implants/participants with an implant placed on a prosthetically driven position
timeFrame: 16 weeks
measure: Mean percentage of residual bone graft particles
timeFrame: 16 weeks
measure: Mean percentage of new bone formation
timeFrame: 16 weeks
measure: Mean percentage of connective tissue
timeFrame: 16 weeks
measure: Mean probing depth
timeFrame: 2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks)
measure: Mean percentage of implant surfaces with bleeding
timeFrame: 2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks)
measure: Mean percentage of implant surfaces with plaque
timeFrame: 2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks)
measure: Mean width of keratinized mucosa
timeFrame: 2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks)
measure: Mean migration of peri-implant mucosal margin
timeFrame: 2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks)
measure: Mean change peri-implant marginal bone level changes
timeFrame: 16 weeks to 2 months after implant placement (approximately 8 weeks) and 16 weeks to 12 months after implant placement (approximately 54 weeks)
measure: Mean implant-crown esthetic score
timeFrame: 12 months after implant placement, approximately 70 weeks
measure: Mean patient satisfaction score
timeFrame: 12 months after implant placement, approximately 70 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Eastman Institute for Oral Health
state: New York
Study officials:
affiliation: Eastman Institute for Oral Health, University of Rochester
name: Elli Anna Kotsailidi, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: