Comparison of Dimensional Changes After Tooth Extractions... | NCT04550689

Studies
Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft

NCT04550689

Sponsor

UConn Health

Status

Active, not recruiting

Last Update Posted

Nov 28, 2023Actual

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Tooth Loss

Interventions

Bone graft

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
601907	Other Grant/Funding Number	Straumann LLC

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Jun 30, 2023Actual

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Sep 7, 2020

First Submission Date that Met QC Criteria

Sep 14, 2020

First Posted Date

Sep 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2023

Last Update Posted Date

Nov 28, 2023Actual

Name	Class
Institut Straumann AG	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Label	Type	Description	Intervention Names
Xenograft	Active Comparator		Device: Bone graft
Allograft	Active Comparator		Device: Bone graft

Name	Type	Description	Arm Group Labels	Other Names
Bone graft	Device	Bone grafts produced by Straumann LLC	Allograft Xenograft

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	6 months

Secondary Outcomes

Measure	Description	Time Frame
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	6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 28, 2025			Sep 16, 2025	5
Sep 29, 2025

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D014076	Tooth Diseases

ID	Term
D016378	Tissue Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics