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Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft (PilotXenAllo)

Primary Purpose

Tooth Loss

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bone graft

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring dental, socket grafting, bone graft, alveolar, xenograft, allograft, implant, ridge preservation, CBCT

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Males or females ≥ 21 years of age
Able to provide informed consent
Good general oral health (no active periodontal disease, absence of hopeless teeth, absence of active caries, absence of acute infections)
Single rooted non molar teeth needing extraction for miscellaneous reasons (since histological analysis is being done, it is essential to harvest bone core biopsies without inclusion of native bone16)
Presence of natural teeth adjacent to the tooth planned for extraction
Absence of acute signs of infection such as pus discharge, fistulous tract and / or abscess in relation to tooth being extracted
Dehiscence type defects of the sockets limited to 2/3rd length of the root

Exclusion Criteria:

Systemic conditions

Conditions and circumstances as evaluated by investigator that would prevent completion of study participation
Conditions requiring chronic routine use of antibiotics or steroids
History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infections
Alcoholism or drug abuse and heavy smokers >10 cigarettes a day
Simultaneous participation in other studies
Pregnancy - Patients pregnant before the start of the study or patients who become pregnant during the course of the study

Local conditions

Untreated periodontitis, caries or presence of hopeless teeth (other than the one planned for extraction)
Multi rooted teeth
Irradiation therapy
Osseous lesions
Missing teeth adjacent to the tooth being extracted
Implant restorations adjacent to the tooth being extracted
Multiple socket walls missing following extraction or buccal dehiscence defect extending to the apex of the root

Sites / Locations

UConn Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Xenograft

Allograft

Arm Description

Outcomes

Primary Outcome Measures

Horizontal and vertical dimensional changes noted on Cone Beam Computed Tomography

Dimensional changes measured from a Cone Beam Computed Tomography immediately post extraction and grafting and 6 months post extraction

Secondary Outcome Measures

Horizontal dimensional changes measured intra-operatively using a Periodontal Probe

Dimensional changes of the crest measured intra-operatively immediately post extraction and grafting and compared to 6 months post extraction. Measurements will be made using a periodontal probe from the Mid-buccal to the mid-palatal/mid-lingual aspect of the ridge using a surgical stent

Vertical dimensional changes measured intra-operatively using a periodontal probe and stent

Dimensional changes of the crest measured intra-operatively immediately post extraction and grafting and compared to 6 months post extraction. Vertical measurements will be made using a periodontal probe and a patient specific stent. The probe will help measure changes in height of buccal and palatal / lingual plate at the center of the ridge.

Histologic analysis of bone biopsy cores

Histologic analysis of the bone biopsy cores taken from the xenograft or allograft grafted extraction sockets

Full Information

NCT ID

NCT04550689

First Posted

September 7, 2020

Last Updated

March 2, 2022

Sponsor

UConn Health

Collaborators

Institut Straumann AG

1. Study Identification

Unique Protocol Identification Number

NCT04550689

Brief Title

Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft

Acronym

PilotXenAllo

Official Title

A Pilot RCT Study Comparing Dimensional Alterations After Socket Grafting With Xenograft Versus Allograft

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

UConn Health

Collaborators

Institut Straumann AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft.

Detailed Description

AIM To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft. PRIMARY OBJECTIVE Horizontal and vertical dimensional changes of extraction sockets as evaluated in a CBCT scan immediately post extraction and 6 months post extraction when grafted with xenograft versus allograft. SECONDARY OBJECTIVE Difference in horizontal dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction. Difference in vertical dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction. Difference in histologic analysis of bone biopsy cores taken in xenograft and allograft groups at 6 months re-entry from osteotomy site. Difference in newly regenerated supracrestal bone height and volume will be measured directly from the segmented images from MicroCT. NULL HYPOTHESIS There is no difference between the two groups for any of the parameters evaluated.

6. Conditions and Keywords

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

Tooth Loss

Keywords

dental, socket grafting, bone graft, alveolar, xenograft, allograft, implant, ridge preservation, CBCT

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel arm with subjects randomly receiving allograft or xenograft for ridge preservation

Masking

ParticipantCare ProviderOutcomes Assessor

Masking Description

The participant, surgeon and assessors of the CBCT will be blinded to the treatment arm. The bone graft will be chosen at random from an envelope with a list generated by Sealed Envelope Ltd

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Xenograft

Arm Type

Active Comparator

Arm Title

Allograft

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Bone graft

Intervention Description

Bone grafts produced by Straumann LLC

Primary Outcome Measure Information:

Title

Horizontal and vertical dimensional changes noted on Cone Beam Computed Tomography

Description

Dimensional changes measured from a Cone Beam Computed Tomography immediately post extraction and grafting and 6 months post extraction

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Horizontal dimensional changes measured intra-operatively using a Periodontal Probe

Description

Time Frame

6 months

Title

Vertical dimensional changes measured intra-operatively using a periodontal probe and stent

Description

Time Frame

6 months

Title

Histologic analysis of bone biopsy cores

Description

Histologic analysis of the bone biopsy cores taken from the xenograft or allograft grafted extraction sockets

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or females ≥ 21 years of age Able to provide informed consent Good general oral health (no active periodontal disease, absence of hopeless teeth, absence of active caries, absence of acute infections) Single rooted non molar teeth needing extraction for miscellaneous reasons (since histological analysis is being done, it is essential to harvest bone core biopsies without inclusion of native bone16) Presence of natural teeth adjacent to the tooth planned for extraction Absence of acute signs of infection such as pus discharge, fistulous tract and / or abscess in relation to tooth being extracted Dehiscence type defects of the sockets limited to 2/3rd length of the root Exclusion Criteria: Systemic conditions Conditions and circumstances as evaluated by investigator that would prevent completion of study participation Conditions requiring chronic routine use of antibiotics or steroids History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infections Alcoholism or drug abuse and heavy smokers >10 cigarettes a day Simultaneous participation in other studies Pregnancy - Patients pregnant before the start of the study or patients who become pregnant during the course of the study Local conditions Untreated periodontitis, caries or presence of hopeless teeth (other than the one planned for extraction) Multi rooted teeth Irradiation therapy Osseous lesions Missing teeth adjacent to the tooth being extracted Implant restorations adjacent to the tooth being extracted Multiple socket walls missing following extraction or buccal dehiscence defect extending to the apex of the root

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sejal Thacker, D.D.S.

Organizational Affiliation

UConn Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

UConn Health

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft

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