Clinical trial NCT06447844: OsteoGen Plug vs. Freeze-dried Bone Allograft With Collagen Barrier
Official title: OsteoGen® Plug vs Freeze-dried Bone Allograft With Collagen Barrier for Alveolar Ridge Preservation (ARP): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nonterminal Premolar Needing Extraction
Lead sponsor: McGuire Institute
Sponsor class: INDUSTRY
Collaborators: name: Impladent LTD
First posted: 2024-06-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen barrier
Primary purpose: TREATMENT

Brief summary: The study will be a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen barrier (Control) for alveolar ridge preservation (ARP) in posterior extraction sites with intact buccal cortical plates.

Detailed description: After tooth extraction and debridement, sockets will be packed with either test product (OGP), or control product (BioGide). Subjects will then undergo follow-up assessments conducted at day 7 (+3 days), day 14 (+3 days), and day 30 (+3 days) for oral exam, PROs, AEs, and complication assessments. Subjects will undergo follow-up assessments conducted at day 60 (+3 days) and day 90 (+3 days), for oral exam, PROs, AEs, complication assessments, standardized PA radiographs. Subjects will undergo follow-up assessments conducted at day 120 (+3 days) for oral exam, PROs, AEs, complication assessments, standardized PA radiograph, intraoral scan, and CBCT.

OPTIONAL Subjects will undergo follow-up assessments conducted at day 135 (+14 days) for oral exam, AEs, complication assessments, histologic core procurement, additional grafting assessment, prosthetic driven implant placement assessment.

Subjects will undergo follow-up assessments conducted at day 143 (+5 days) for oral exam, AEs, end of study.

Eligibility criteria: Inclusion Criteria:

* Subjects 18 to 75-yrs of age.
* Subjects with a nonterminal premolar in need of extraction with intention to pursue implant replacement.
* Proposed treatment site must have intact buccal cortical plates \> 1 mm in thickness (buccal bone dehiscence up to 25% root length is permissible). Apical lesions are acceptable which do not perforate the cortical plate).
* Proposed treatment site must have intact adjacent natural teeth. (no adjacent edentulous sites or implants).
* Subjects can provide self-care (oral hygiene) without disabilities requiring assistance with daily oral hygiene measures.
* Subjects will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
* Subjects must be able and willing to follow study procedures and instructions.

Exclusion Criteria:

* Subjects with reported allergy or hypersensitivity to any of the products to be used in the study.
* Subjects with untreated / active periodontal disease.
* Subjects with vesiculobullous processes or other similar chronic oral lesions / conditions resulting in gingival irritation, discomfort/pain, or erosions.
* Tobacco/Cannabis users including cigarettes, vape, cigars, or smokeless tobacco.
* Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, cancer)
* Subjects who are lactating or pregnant or planning to become pregnant through their projected study duration.
* Subjects who would require a tissue supported interim prosthesis i.e. acrylic / valplast RPD (tooth supported interim prostheses i.e. essix retainers are acceptable)
* Subjects with long-term history of oral bisphosphonates (\> 10 years).
* Subjects with a history of intravenous bisphosphonates.
* Subjects taking medications known to affect gingival conditions. (e.g., hyperplasia)
* Subjects taking corticosteroids or immunosuppressants on a regular basis prior to baseline examination.
* Subjects taking anticoagulant medications such as warfarin or Plavix or Eliquis who are not medically cleared to hold medication prior to and during procedure.
* Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental).
* Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

Primary outcomes:
measure: New bone formation
timeFrame: 120 days
Secondary outcomes:
measure: Change in ridge height compared to screening as determined by Cone Beam Cat Scan (CBCT)
timeFrame: 120 days
Other outcomes:
measure: Change in ridge width compared to screening at 3mm and 5mm below crest
timeFrame: 120 days
measure: Volumetric analysis of soft tissue/ridge height and width via intraoral scans
timeFrame: 120 days
measure: Histologic assessment of NBF (new bone formation), RG (residual graft particle) and connective tissue at 4 months if implant is placed
timeFrame: 4 months post implant placement
measure: wound closure assessment
timeFrame: 120 days
measure: number of treatment sites requiring additional grafting at time of implant placement
timeFrame: During procedure (time of implant placement)
measure: cost effectiveness analysis
timeFrame: 120 days
measure: baseline buccal plate thickness influence on outcomes
timeFrame: 120 days
measure: change in phenotype
timeFrame: 120 days
measure: time comparison between treatment groups from post extraction to ARP procedure completion (final suture)
timeFrame: surgical visit
measure: Change in ridge width compared to screening at crest as determined by CBCT. Change in ridge width compared to baseline screening at crest as determined by CBCT. Change in ridge width compared to screening at crest as determined by CBCT.
timeFrame: 120 days
measure: complication type and incidence rates
timeFrame: 120 days
measure: Prosthetic driven implant feasibility assessment
timeFrame: 120 days
measure: Safety and tolerability/biocompatibility:Adverse events
timeFrame: 120 days
measure: Patient demographics and robust health history influence outcomes
timeFrame: 120 days
measure: Patient reported outcomes (pain, satisfaction)
timeFrame: 120 days
measure: Clinician reported outcomes for usability (ease of use, time for each graft procedure, site vascularity)
timeFrame: visit 2 post surgery
measure: Long term implant assessments
timeFrame: post implant placement (outside of study after 120 days)
measure: histology cores if implant placement in future
timeFrame: post implant placement (outside of study after 120 days)
Locations:
city: Aurora
country: United States
facility: McClain and Schallhorn Periodontics and Implant Dentistry
state: Colorado
city: Broomfield
country: United States
facility: Colorado Gum Care
state: Colorado
city: Boston
country: United States
facility: The Perio Studio
state: Massachusetts
city: Fenton
country: United States
facility: Seven Lakes Periodontics
state: Michigan
city: Nashville
country: United States
facility: Perio & Implant Associates of Middle TN
state: Tennessee
city: Houston
country: United States
facility: Perio Health Professionals
state: Texas
city: Victoria
country: United States
facility: Gulf Coast Periodontics
state: Texas
city: Kenosha
country: United States
facility: WisNova Institute of Dental Specialists
state: Wisconsin
Study officials:
References: