NCT06187805

Brief Summary

This study is designed as a retrospective, single center study. Up to 15 participants who had a transcrestal sinus elevation and implant placement using autogenous bone supporting an OSSIX Volumax collagen xenograft scaffolding will be enrolled. The study will include data collection from medical records and data collected at a follow up visit between January 2019 and March 2023.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 17, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

December 17, 2023

Last Update Submit

January 3, 2024

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (1)

  • Change in crestal bone height

    Measured radiographically and by cone beam computed tomography at follow up

    4 months to 57 months

Study Arms (1)

Up to 15 patients

Patients who have had a transcrestal elevation using autogenous bone supporting an OSSIX Volumax collagen scaffolding.

Device: OSSIX Volumax

Interventions

OSSIX VolumaxDEVICE

OSSIX Volumax is used in combination with autogenous bone collected during preparation of the implant osteotomy.

Up to 15 patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Up to 15 participants who meet the I/E will have data retrospectively reviewed and will include follow up data.

You may qualify if:

  • Transcrestal sinus lift planned
  • Implant therapy planned
  • Crestal bone height \< or equal to 6mm
  • Missing tooth or teeth for function
  • Nonsmoker -

You may not qualify if:

  • Patients with known collagen hypersensitivity
  • Patients with sensitivity to porcine-derived materials
  • Patients suffering from autoimmune diseases and connective tissue diseases, such as lupus erythematosus, dermatomyositis, etc.
  • Pregnant or planning to become pregnant (verbal confirmation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Old Orchard Periodontics and Implant Dentistry

Skokie, Illinois, 60077, United States

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2023

First Posted

January 3, 2024

Study Start

November 16, 2023

Primary Completion

January 1, 2024

Study Completion

February 2, 2024

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

US(1)