NCT01836783

Brief Summary

The study will compare the density and strength of regenerated bone in extraction sockets after being grafted with two different materials: Bone Allograft and Bone Allograft with Amnion. The investigators hypothesize that sockets grafted with the Amnion graft will exhibit enhanced healing patterns and will accelerate the formation of regenerated bone in the grafted areas.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 10, 2024

Completed
Last Updated

June 10, 2024

Status Verified

December 1, 2023

Enrollment Period

8.4 years

First QC Date

April 17, 2013

Results QC Date

December 15, 2023

Last Update Submit

December 15, 2023

Conditions

Tooth Loss

Keywords

AllograftAmnion Allograft

Outcome Measures

Primary Outcomes (1)

  • Changes in Hard Tissue Composition

    A biopsy will be harvested from each grafted-site and sent to a laboratory for histological and histomorphometric analysis

    baseline to week-8

Secondary Outcomes (2)

  • Changes in Soft Tissue Healing

    baseline to 2 weeks

  • Changes in Soft Tissue Healing

    2 weeks to 7 weeks

Study Arms (2)

Amnion Allograft

EXPERIMENTAL

Atraumatic tooth extractions and amnion allograft procedures

Other: Amnion Allograft

Allograft

ACTIVE COMPARATOR

Atraumatic tooth extractions and allograft procedures

Other: Allograft

Interventions

Amnion AllograftOTHER

Atraumatic extraction and grafting procedures will be followed by insertion of a dental implant into the grafted area at week-8. The implant will be restored and be monitored for 24 months post-insertion. Two special dental cone-beam CT images (pre-baseline and week-7) and a minimum of 6 intraoral radiographs will be taken during the study

Amnion Allograft
AllograftOTHER

Atraumatic extraction and grafting procedures will be followed by insertion of a dental implant into to the grafted area at week-8. The implant will be restored and be monitored for 24 months post-insertion. Two special dental cone-beam CT images (pre-baseline and week-7) and a minimum of 6 intraoral radiographs will be taken during the study

Allograft

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be a registered University of Alabama at Birmingham (UAB) dental school patient
  • Existence of one or more non-adjacent teeth in the aesthetic zone that are scheduled for extraction
  • Healthy enough to undergo the proposed therapy
  • Demonstrated willingness to comply with study directions and time-line
  • Able to consent for themselves
  • Able to read and understand the informed consent form -

You may not qualify if:

  • Pregnant or lactating at the time of enrollment
  • Previous Malignant neoplasm
  • Known hypersensitivity to bone grafting materials
  • Know hypersensitivity to titanium
  • Any medical of medication that in the opinion of the investigators may adversely affect bone healing
  • Any indication of an inability to make autonomous decisions -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, 35294-0007, United States

Location

MeSH Terms

Conditions

Tooth Loss

Interventions

Transplantation, Homologous

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Results Point of Contact

Title
Maninder Kaur, BDS, MPH, MS, Principal Investigator
Organization
University of Alabama at Birmingham
maninder@uab.edu
205-9344506

Study Officials

  • Maninder Kaur, BDS MPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 22, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2021

Study Completion

October 1, 2023

Last Updated

June 10, 2024

Results First Posted

June 10, 2024

Record last verified: 2023-12

Locations

US(1)