Comparison of Two Types of Bone Grafts in Patients Who Need One of Their Front Teeth Removed and Replaced With an Implant
NCT ID: NCT06722482
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-11-27
2026-11-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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FDBA arm
FDBA
Twenty five participants will receive FDBA in anterior extraction sockets as part of the alveolar ridge preservation procedure.
CEBX arm
CEBX
Twenty five participants will receive CEBX in anterior extraction sockets as part of the alveolar ridge preservation procedure.
Interventions
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FDBA
Twenty five participants will receive FDBA in anterior extraction sockets as part of the alveolar ridge preservation procedure.
CEBX
Twenty five participants will receive CEBX in anterior extraction sockets as part of the alveolar ridge preservation procedure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Implant Dentistry Research & Education Foundation (IDREF)
UNKNOWN
University of Rochester
OTHER
Responsible Party
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Elli Kotsailidi
Assistant professor
Principal Investigators
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Elli Anna Kotsailidi, DDS, MS
Role: PRINCIPAL_INVESTIGATOR
Eastman Institute for Oral Health, University of Rochester
Locations
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Eastman Institute for Oral Health
Rochester, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Elli Anna Kotsailidi, DDS, MS
Role: primary
Nasser Assery, BDS, MS
Role: backup
Other Identifiers
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AWD00006192
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY00008216
Identifier Type: -
Identifier Source: org_study_id