NCT07098325

Brief Summary

The aim of this study will be to evaluate the biological reaction of direct three dimensional printed retainers. Primary objective is to evaluate bacterial growth and color stability between different thicknesses of 3d printed material used as a retainer . Secondary objective is to determine the optimal thickness for use in clear aligner fabrication based on biological performance.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress36%
Oct 2025Jun 2027

First Submitted

Initial submission to the registry

July 8, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

July 8, 2025

Last Update Submit

July 25, 2025

Conditions

Orthodontic Retainers

Keywords

Different thicknessesDirect three dimensional printed retainersBacterial growthColor change

Outcome Measures

Primary Outcomes (2)

  • Bacterial growth measured using colony-forming unit (CFU) count on agar plates.

    Saliva samples will be collected from each participant at baseline and at day 14. Samples will be cultured on standard agar plates under aerobic conditions. After incubation, bacterial colonies will be counted, and results will be expressed in colony-forming units per milliliter (CFU/ml). A higher CFU value indicates greater bacterial growth. Units: CFU/ml

    from day 0 (Baseline time ) to 14 days after insertion

  • Color change of 3D printed retainers measured using spectrophotometer; ΔE calculated at day 0 and day 14.

    The color stability of the retainers will be assessed using a spectrophotometer (VITA Easyshade or equivalent). Color difference (ΔE) will be calculated between baseline and day 14. A ΔE \> 3.3 is considered clinically perceptible. Scale range: 0-10; higher ΔE score indicates greater color change and worse color stability. Units: ΔE (Delta E) score

    from day 0 (baseline time ) to 14 days after insertion

Study Arms (2)

direct 3d printed retainer of .5mm

EXPERIMENTAL

group wearing direct 3d retainer of .5 mm

Device: retainer with .5 mm thickness

direct 3d printed retainer of 1mm

EXPERIMENTAL

group wearing direct 3 d retainer with thickness 1 mm

Device: retainer with 1 mm thickness

Interventions

retainer with .5 mm thicknessDEVICE

direct 3d printed retainer with .5 mm thickness

direct 3d printed retainer of .5mm
retainer with 1 mm thicknessDEVICE

direct 3d printed retainer with 1 mm thickness,

direct 3d printed retainer of 1mm

Eligibility Criteria

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

You may qualify if:

  • Finished fixed orthodontic therapy and seeking for retention as a part of their original treatment plan.
  • Good oral hygiene.
  • No habits (e.g., smoking)

You may not qualify if:

  • Medication affecting saliva.
  • intrinsic tooth discoloration.
  • Uncooperative patients.
  • Patient with periodontitis.
  • Learning difficulties and inability to read written instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine , Al-Azhar University

Asyut, Egypt

RECRUITING

MeSH Terms

Interventions

Orthodontic Retainers

Intervention Hierarchy (Ancestors)

Orthodontic AppliancesOrthodonticsDentistry

Study Officials

  • Dr. Mustafa Mohamed Mahmoud Dawaba Associate Professor of Orthodontics

    Faculty of Dental Medicine, Al-Azhar University Assiut Branch

    STUDY CHAIR

  • Dr. Mahmoud Mohamed Salah El-din Ibrahim Lecturer of Orthodontics

    Faculty of Dental Medicine , Al-Azhar University Assiut Branch

    STUDY CHAIR

Central Study Contacts

Norhan Ibrahim Eldsokee Master's Candidate, B.D.S

CONTACT

+20 01559921144noureldsokee@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Master's Candidate at Orthodontic department at Al-Azhar University, Assiut branch.

Study Record Dates

First Submitted

July 8, 2025

First Posted

August 1, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

August 1, 2025

Record last verified: 2025-07

Locations

EG(1)