Clinical trial NCT05219305: Implant Stability in Autogenous Mineralized and Demineralized Dentin Grafts
Official title: Autogenous Mineralized Dentin Graft Compared to Partial Demineralized Tooth Graft and to Freeze-Dried Bone Allograft in Dental Implant Placement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Edentulous Alveolar Ridge
Keywords: dental implant,
autogenous dentin graft
autograft
allograft
bone graft
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2022-02-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants originate from previous study ""Alveolar Ridge Preservation with evenly distributed experimental groups of FDBA, Mineralized, and Partially Demineralized Dentin Grafts". They have already been assigned and treated with different types of bone grafts. They were assigned groups via a computer randomization program.
Primary purpose: TREATMENT

Brief summary: The bone grafting materials currently used in dentistry are autografts, allografts, xenografts, and alloplastic grafts. Among these different types of bone graft materials, autografts are considered to have the most predictable results due to their properties of osteogenesis, osteoinduction, and osteoconduction. However, bone autografts are rarely used due to the high morbidity associated with harvesting the bone graft from the patient with a second surgical site. Because of the increased risk to the patient with autogenous bone grafts, the current standard of care is an allograft, which is a bone graft harvested from cadaver sources such as Freeze-Dried Bone Allograft (FDBA). While allografts can only possess the qualities of osteoinduction and osteoconduction, they also have dramatically less morbidity due to the lack of a second surgical site.

Our null hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) do not show positive changes in implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA

Our alternative hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) show similar or better results in terms of implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA.

Detailed description: This study will be a randomized controlled trial that will assess the changes in implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes recorded by ISQ (Implant Stability Quotient), probing pocket depths, x-ray, and direct clinical measurements which are routinely taken as a standard of care for the dental procedures of implant placement and evaluation. A non-invasive standardizing stent with a caliper will be used for direct measurements and for bitewing radiographs for the purpose of evaluating changes in bone level. Those measurements will be taken immediately at the time of implant placement, and 4-6 months after implant placement. Calibrated examiners will evaluate implant integration. This research will be carried out by a blinded examiner who will not know the grafted material type to prevent bias.

Interventions and follow-up appointments will be conducted at the University of Oklahoma (OU), Graduate Periodontics clinic. Approximately 5 visits are anticipated for each patient. Additional appointments may be needed depending on surgical complications that need attention or intervention. Following the completion of the study, the participants will be placed on appropriate recall schedules either at the Graduate Periodontics clinic or referred to their dentist of choice. The subject's information will not be used or distributed for future research studies even if identifiers are removed.

Patients from the previous study "Alveolar Ridge Preservation with evenly distributed experimental groups of FDBA, Mineralized, and Partially Demineralized Dentin Grafts". A total of 60 patients treated with Alveolar Ridge Preservation will be eligible for implant placement.

Protocol of the experiment is as follows:

1. Surgical intervention for implant placement (for all the groups).
2. 2-week follow-up after implant placement.
3. 6-week follow-up after implant placement.
4. 4-6 month follow-up after implant placement.
5. Restoration of the implant by the restorative dentist.
6. Data analysis

During the implant placement phase, at 4 to 6 months postoperative from the grafted sites, bone core sample will be collected using a trephine bur. Collection of sample with a trephine bur will come from area of bone being prepared for the dental implant and will be of a size that would have been removed during dental implant preparation anyway. This will occur during the same appointment as dental implant placement. The collected specimens will be labeled (name of the patient, date, and chart number) and sent to the OU Department of Oral Pathology where it will be analyzed for newly formed bone and the amount of residual bone graft material. This research will be carried out by a blinded examiner who will not know the grafted material type to prevent bias.

No population will be excluded based on race or gender. Patients under 18 years old will be excluded due to the ongoing growth potential of the alveolar bone at a younger age.

This study will be conducted at the University of Oklahoma, College of Dentistry, Department of Graduate Periodontics. Participants will be selected from patients of the College of Dentistry. Qualifying subjects will be scheduled for a screening examination appointment.

Eligibility criteria: Inclusion Criteria:

* Adult patients ≥18 years old. Current literature suggests that patients up to age 80 can safely receive dental implants. Patients older than 80 can get implant therapy with a rate of implant failure increase of 2.26%, but not statistically significant (Bertl et al. 2019)
* Well-controlled systemic disease.
* Able to understand and sign a written informed consent form and willing to fulfill all study requirements.

Exclusion Criteria:

* Uncontrolled systemic disease.
* Currently smoking \>10 cigarettes per day.
* History of head and/or neck radiotherapy in the past five years.
* Current use of bisphosphonates or history of IV bisphosphonate therapy.
* Pregnant, expecting to become pregnant, or lactating women.
* Presence of active periodontal disease.

Primary outcomes:
measure: Implant Stability as Measured with ISQ values of implant
timeFrame: 6 months
measure: Implant Failure Rate
timeFrame: 6 months
measure: Probing pocket depth
timeFrame: 6 months
measure: Interproximal crestal bone level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma College of Dentistry Graduate Periodontics
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Robin Henderson, DDS, MS
role: PRINCIPAL_INVESTIGATOR
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