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Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts

Primary Purpose

Alveolar Bone Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PUROS (Ridge Preservation bone grafting surgery)

FDBA (Ridge Preservation bone grafting surgery)

About this trial

This is an interventional treatment trial for Alveolar Bone Loss

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:Patients will be included in this study if they qualify the following inclusion criteria:

Live within 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio
Are able to attend a minimum of 6 visits over a 4-5 month period, as required by the study protocol
A single rooted tooth that has been identified as requiring extraction
Desire a dental implant to replace the missing tooth
Have adequate restorative space for a dental implant-retained restoration
Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
Have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket.
Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential.
Are nonsmokers or former smokers. Current smokers may only be included if they smoke <10 cigarettes per day

Exclusion Criteria:

Patients who live more than 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio
Patients who do not meet all the inclusion criteria or who will not cooperate with the required follow-up schedule.
Patients will are mentally incompetent, prisoners, or pregnant.
Pregnant women or women intending to become pregnant during the study period.
Smokers who smoke >10 cigarettes per day
Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active infection other than periodontitis; Inadequate bone dimensions or restorative space for a dental implant; Presence of a disease entity, condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy; Positive medical history of endocarditis following oral or dental surgery.
Sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or surfactants

Sites / Locations

UT Health Science Center at San Antonio, School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PUROS (Non-Freeze-Dried bone allograft)

FDBA (Freeze-Dried bone allograft)

Arm Description

Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)

Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)

Outcomes

Primary Outcome Measures

% Vital Bone Formation (Histological)

histologic determination of % of vital bone formation

Secondary Outcome Measures

% Residual Graft Material (Histological)

histologic determination of % of residual bone graft material

Full Information

NCT ID

NCT02515058

First Posted

July 31, 2015

Last Updated

December 18, 2017

Sponsor

The University of Texas Health Science Center at San Antonio

1. Study Identification

Unique Protocol Identification Number

NCT02515058

Brief Title

Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts

Official Title

Ridge Preservation Following Tooth Extraction Using Mineralized Freeze-Dried Bone Allograft Compared to PUROS Mineralized Bone Allograft

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

September 2017 (Actual)

Study Completion Date

September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bone allograft that has been prepared by either freeze-drying or via a non-freeze-dried solvent process.This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called FDBA). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome). Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a resorbable collagen membrane. Following 3 months of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.

Detailed Description

The study is designed to examine histologic wound healing following ridge preservation using cancellous bone allograft that has been prepared either by freeze-drying (FDBA) or by a solvent-based processing method (PUROS). This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called FDBA). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome). Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a resorbable collagen membrane. Following 3 months of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alveolar Bone Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PUROS (Non-Freeze-Dried bone allograft)

Arm Type

Experimental

Arm Description

Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)

Arm Title

FDBA (Freeze-Dried bone allograft)

Arm Type

Active Comparator

Arm Description

Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)

Intervention Type

Device

Intervention Name(s)

PUROS (Ridge Preservation bone grafting surgery)

Intervention Description

Ridge preservation bone grafting after tooth extraction

Intervention Type

Device

Intervention Name(s)

FDBA (Ridge Preservation bone grafting surgery)

Intervention Description

Ridge preservation bone grafting after tooth extraction

Primary Outcome Measure Information:

Title

% Vital Bone Formation (Histological)

Description

histologic determination of % of vital bone formation

Time Frame

3 months after ridge preservation

Secondary Outcome Measure Information:

Title

% Residual Graft Material (Histological)

Description

histologic determination of % of residual bone graft material

Time Frame

3 months after ridge preservation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria:Patients will be included in this study if they qualify the following inclusion criteria: Live within 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio Are able to attend a minimum of 6 visits over a 4-5 month period, as required by the study protocol A single rooted tooth that has been identified as requiring extraction Desire a dental implant to replace the missing tooth Have adequate restorative space for a dental implant-retained restoration Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal. Have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket. Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential. Are nonsmokers or former smokers. Current smokers may only be included if they smoke <10 cigarettes per day Exclusion Criteria: Patients who live more than 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio Patients who do not meet all the inclusion criteria or who will not cooperate with the required follow-up schedule. Patients will are mentally incompetent, prisoners, or pregnant. Pregnant women or women intending to become pregnant during the study period. Smokers who smoke >10 cigarettes per day Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active infection other than periodontitis; Inadequate bone dimensions or restorative space for a dental implant; Presence of a disease entity, condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy; Positive medical history of endocarditis following oral or dental surgery. Sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or surfactants

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian L. Mealey, DDS, MS

Organizational Affiliation

UT Health Science Center at San Antonio, School of Dentistry

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT Health Science Center at San Antonio, School of Dentistry

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30161278

Citation

Corning PJ, Mealey BL. Ridge preservation following tooth extraction using mineralized freeze-dried bone allograft compared to mineralized solvent-dehydrated bone allograft: A randomized controlled clinical trial. J Periodontol. 2019 Feb;90(2):126-133. doi: 10.1002/JPER.18-0199. Epub 2018 Sep 19.

Results Reference

derived

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Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts

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