NCT06262802

Brief Summary

Null hypothesis active decompression and distraction sugosteogenesis is not faster than passive decompression in volume reduction of large cystic lesions

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 Mar 2024

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

February 7, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

February 7, 2024

Last Update Submit

February 14, 2024

Conditions

Odontogenic Cysts

Outcome Measures

Primary Outcomes (1)

  • Volume change

    Percentage of volume changes over time

    2weeks/one and 6 months

Study Arms (2)

Intervention

EXPERIMENTAL
Device: Active decompression

Control

ACTIVE COMPARATOR
Device: Active decompression

Interventions

Active decompressionDEVICE

Intracystic active negative pressure

ControlIntervention

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • any patient with large cystic lesion

You may not qualify if:

  • any patient can't follow home instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Odontogenic Cysts

Condition Hierarchy (Ancestors)

Jaw CystsBone CystsCystsNeoplasmsJaw DiseasesMusculoskeletal DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 16, 2024

Study Start

March 1, 2024

Primary Completion

September 1, 2024

Study Completion

March 1, 2025

Last Updated

February 16, 2024

Record last verified: 2024-02