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Completed

NCT Number: NCT05311735

Mineralized and Partial Demineralized Dentin Graft Compared to FDBA

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 its 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.

Studies have shown that autogenous dentin grafts promote all three ideal mechanisms for bone regeneration. There are two methods to generate autogenous dentin grafts. One is to collect the extracted tooth and to send it to a tooth bank for the preparation process. The second is to process the extracted tooth in a clinical setting chairside, for a graft. A dentin graft can undergo different treatments such as demineralization, mineralization, and partial-demineralization. Although the autogenous dentin graft has shown positive results for bone regeneration, the comparison between partial-demineralized, mineralized autogenous dentin grafts, and freeze-dried bone grafts in the clinical setting for immediate grafting has not been studied in humans. Thus, there is a need to study the benefits of autogenous dentin partial-demineralized and mineralized grafts versus freeze-dried bone allografts regarding clinical, radiographically (bone volume and density), and efficacy results. This research addresses these areas of need.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma College of Dentistry Graduate Periodontics

Oklahoma City, Oklahoma, 73117, United States

About this study

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 its 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.

Studies have shown that autogenous dentin grafts promote all three ideal mechanisms for bone regeneration. There are two methods to generate autogenous dentin grafts. One is to collect the extracted tooth and to send it to a tooth bank for the preparation process. The second is to process the extracted tooth in a clinical setting chairside, for a graft. A dentin graft can undergo different treatments such as demineralization, mineralization, and partial-demineralization. Although the autogenous dentin graft has shown positive results for bone regeneration, the comparison between partial-demineralized, mineralized autogenous dentin grafts, and freeze-dried bone grafts in the clinical setting for immediate grafting has not been studied in humans. Thus, there is a need to study the benefits of autogenous dentin partial-demineralized and mineralized grafts versus freeze-dried bone allografts regarding clinical, radiographically (bone volume and density), and efficacy results. This research addresses these areas of need.

A. Specific Aims

Specific Aim 1:

Is there a clinical-radiographical difference in terms of bone volume and density between mineralized dentin grafts, partial demineralized tooth grafts, and FDBA?

Null Hypothesis (Ho): Experimental groups (Mineralized, and partial demineralized dentin grafts) do not have positive changes in terms of bone volume and density when compared to FDBA

Alternative Hypothesis (H1): Experimental groups (Mineralized, and partial demineralized dentin grafts) show better results in terms of bone volume and density when compared to FDBA.

Secondary Aim:

Evaluate if there is any difference in terms of efficacy among partial-demineralized dentin graft, mineralized dentin graft and FDBA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients ≥18 years old
  • Able to understand and sign a written informed consent form and willing to fulfil all study requirements.
  • Alveolar sockets with intact four-wall architecture.
  • Patients with at least a tooth that need to be extracted.

Exclusion criteria

  • Uncontrolled systemic disease
  • Currently smoking >10 cigarettes per day
  • History of head and/or neck radiotherapy in the past five years
  • Bisphosphonates current use or history of IV bisphosphonate
  • Pregnant, expecting to become pregnant, or lactating women.
  • Presence of active periodontal disease.
  • Teeth that underwent root canal fillings
  • Teeth with acute infection at the site of extraction.
  • Teeth with periapical infection

Treatment and study plan

Freeze-Dried Bone Allograft control

Procedure

Bone grafting to prevent alveolar ridge collapse after tooth removal

Mineralized Dentin Graft

Procedure

Mineralized tooth graft used as a bone graft substitute to prevent alveolar ridge collapse after tooth removal

Partial-Demineralized Dentin Graft

Procedure

Partially mineralized tooth graft used as a bone graft substitute to prevent alveolar ridge collapse after tooth removal

Primary outcomes

  1. Clinical-radiographical differences in terms of bone volume between dentin tooth grafts and FDBA.

    Time frame: 6 months post guided bone regeneration procedure

    Is there a clinical-radiographical difference in terms of bone volume between mineralized dentin grafts, partial demineralized tooth grafts and FDBA, as measured in millimeters, with calibrated devices?

  2. Clinical-radiographical differences in terms of bone density between dentin tooth grafts and FDBA.

    Time frame: 6 months post guided bone regeneration procedure

    Is there a clinical-radiographical difference in terms of bone density between mineralized dentin grafts, partial demineralized tooth grafts and FDBA, as measured with Hounsfield Units?

Secondary outcomes

  1. Surgical efficiency utilizing dentin tooth graft and FDBA.

    Time frame: 6 months post guided bone regeneration procedure

    Is there any difference in terms of surgical efficiency among partial-demineralized tooth graft, mineralized tooth graft and FDBA, as determined by length of time of surgical procedure?

  2. Surgical cost saving measurement utilizing dentin tooth graft and FDBA.

    Time frame: 6 months post guided bone regeneration procedure

    Is there any difference in terms of surgical cost savings among partial-demineralized tooth graft, mineralized tooth graft and FDBA, as determined by length of time of surgical procedure, as measured by the total overhead expended per procedure type?

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Delta Dental Foundation

Registry information

Official study title

Autogenous Mineralized and Partial Demineralized Dentin Graft Compared to Freeze Dried Bone Allograft: A Randomized Control Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Apr 5, 2022
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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