NCT05339971

Brief Summary

Evaluation of the surgical result (augmentation volume, proportion of newly formed bone) after perforation of the bone block in the course of lateral block augmentation prior to planned implant installation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Status
unknown

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

December 7, 2016

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

7 years

First QC Date

April 9, 2022

Last Update Submit

April 15, 2022

Conditions

Bone Augmentation

Outcome Measures

Primary Outcomes (3)

  • Histomorphometry

    % of new bone formation

    at implant installation (approximately 6 months after augmentation)

  • Radiographic

    Volume gain (mm3) after block augmentation at the buccal aspect

    6 months after block augmentation

  • Radiographic

    Volume gain (mm3) after block augmentation at the buccal aspect

    12 months after block augmentation

Study Arms (1)

block perforation

EXPERIMENTAL
Other: block perforation

Interventions

block perforationOTHER

The bone block used for lateral bone augmentation will be perforated several times.

block perforation

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • single tooth gap in need of lateral bone augmentation prior to implant installation

You may not qualify if:

  • untreated periodontal disease
  • systemic disease and/or medication intake with significant effect on bone healing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2022

First Posted

April 21, 2022

Study Start

December 7, 2016

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

April 21, 2022

Record last verified: 2022-04