NCT06366737

Brief Summary

en-mass retraction by lingual retractor versus clear alighner therapy

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

March 28, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

March 28, 2024

Last Update Submit

September 16, 2024

Conditions

Maxillary Prognathism

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction during & after phase I treatment.

    questionnaire

    6 months

Secondary Outcomes (1)

  • inclination of upper anterior teeth

    6 months

Study Arms (2)

KILBON appliance

ACTIVE COMPARATOR

en-mass retraction by lingual retractor

Device: KILBON Appliance

CAT appliance

ACTIVE COMPARATOR

en-mass retraction by clear aligner

Device: CAT appliance

Interventions

KILBON ApplianceDEVICE

palatal TAD assissted lingual appliance for en-mass retraction

KILBON appliance
CAT applianceDEVICE

palatal TAD assissted clear aligner

CAT appliance

Eligibility Criteria

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

You may qualify if:

  • adult patients with maxillary dentoalveolar protrusion with mild crowding

You may not qualify if:

  • \- adult patients with maxillary dentoalveolar protrusion with moderate to severe crowding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, PhD candidate

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 16, 2024

Study Start

October 1, 2024

Primary Completion

June 1, 2025

Study Completion

August 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

EG(1)