Implant Stability in Autogenous Mineralized and Demineralized Dentin Grafts

November 20, 2023 updated by: University of Oklahoma

Autogenous Mineralized Dentin Graft Compared to Partial Demineralized Tooth Graft and to Freeze-Dried Bone Allograft in Dental Implant Placement

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • University of Oklahoma College of Dentistry Graduate Periodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Freeze-Dried Bone Allograft
edentulous site grafted with FDBA in previous study.
Device: Dental Implant Placement
Placement in an edentulous site that was previously bone grafted in the prior study.
Experimental: Partially-demineralized tooth graft
edentulous site grafted with partially-demineralized tooth graft in the previous study.
Device: Dental Implant Placement
Placement in an edentulous site that was previously bone grafted in the prior study.
Experimental: mineralized tooth graft
edentulous site grafted with mineralized tooth graft in the previous study.
Device: Dental Implant Placement
Placement in an edentulous site that was previously bone grafted in the prior study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Stability as Measured with ISQ values of implant
Time Frame: 6 months
Measurement of ISQ (Implant Stability Quotient) values of implant at follow-up appointments
6 months
Implant Failure Rate
Time Frame: 6 months
Necessity of implant of implant removal from oral cavity
6 months
Probing pocket depth
Time Frame: 6 months
measuring the depth of the periodontal pocket alongside the dental implant
6 months
Interproximal crestal bone level
Time Frame: 6 months
radiographically assess bone level changes adjacent to dental implant
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

Zimmer Biomet

Investigators

  • Principal Investigator: Robin Henderson, DDS, MS, University of Oklahoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

August 10, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

January 18, 2022

First Submitted That Met QC Criteria

January 18, 2022

First Posted (Actual)

February 2, 2022

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study records will be stored in a locked room and electronic records will be stored on an encrypted server, which meets the University IT Security requirements. Patient information will be kept within the University of Oklahoma.

These records will be stored indefinitely on the server and available to copying and for future studies if requested under the supervision of a designated representative and in accordance with federal regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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