NCT07730476

Brief Summary

This randomized clinical trial aims to compare the clinical performance of two types of three-dimensionally printed fixed retainers (Cobalt-Chromium and Titanium Grade 5) with the conventional multistranded stainless steel fixed retainer following orthodontic treatment. Thirty-six participants will be randomly allocated into three parallel groups with a 1:1:1 allocation ratio. The primary outcome is post-treatment stability assessed by Little's Irregularity Index and lower arch dimensions. Secondary outcomes include bond failure rate and periodontal parameters over a 12-month follow-up period.

Trial Health

65
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Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Aug 2026

Status
not yet 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

First Submitted

Initial submission to the registry

July 7, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 7, 2026

Last Update Submit

July 30, 2026

Conditions

MalocclusionOrthodontic Relapse

Keywords

Orthodontic retentionFixed retainer3D-printed retainerCobalt-ChromiumTitaniumMultistranded stainless steel retainerRandomized clinical trialLittle's Irregularity Index

Outcome Measures

Primary Outcomes (1)

  • Orthodontic stability assessed using Little's Irregularity Index

    Orthodontic stability will be assessed using Little's Irregularity Index on digital models. The Little's Irregularity Index ranges from 0 mm to higher positive values. A score of 0 mm indicates perfect alignment. Higher scores indicate greater relapse, whereas lower scores indicate better orthodontic stability.

    12 months

Secondary Outcomes (5)

  • Retainer failure rate

    12 months

  • Plaque Index (Silness and Löe Plaque Index)

    12 months

  • Gingival Index (Löe and Silness Gingival Index)

    12 months

  • Bleeding on Probing (BOP)

    12 months

  • Probing Pocket Depth (PPD)

    12 months

Study Arms (3)

Conventional Stainless Steel Fixed Retainer

EXPERIMENTAL

Participants receive a conventional multistranded stainless steel fixed retainer bonded after orthodontic debonding.

Device: Conventional Multistranded Stainless Steel Fixed Retainer

3D-Printed Cobalt-Chromium Fixed Retainer

EXPERIMENTAL

Participants receive a customized 3D-printed cobalt-chromium fixed retainer bonded after orthodontic debonding

Device: 3D-Printed Cobalt-Chromium Fixed Retainer

3D-Printed Titanium Fixed Retainer

EXPERIMENTAL

Participants receive a customized 3D-printed titanium (Ti-6Al-4V) fixed retainer bonded after orthodontic debonding.

Device: 3D-Printed Titanium Fixed Retainer

Interventions

Conventional Multistranded Stainless Steel Fixed RetainerDEVICE

Conventional 0.0215-inch six-stranded stainless steel bonded fixed retainer.

Conventional Stainless Steel Fixed Retainer
3D-Printed Cobalt-Chromium Fixed RetainerDEVICE

Customized 3D-printed cobalt-chromium bonded fixed retainer fabricated from intraoral scans.

3D-Printed Cobalt-Chromium Fixed Retainer
3D-Printed Titanium Fixed RetainerDEVICE

Customized 3D-printed titanium (Ti-6Al-4V) bonded fixed retainer fabricated from intraoral scans.

3D-Printed Titanium Fixed Retainer

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range 21-35 years old after finishing orthodontic treatment.
  • Presence of all maxillary and mandibular anterior teeth with normal shape and size.
  • Completion of orthodontic treatment with full fixed appliances.

You may not qualify if:

  • Patients with cleft lip and/or palate or any other craniofacial syndrome
  • Patients with compromised oral hygiene or periodontal disease
  • Patients who had orthognathic surgery
  • Lingual appliance treatments
  • Enamel hypoplasia, fluorosis, active caries, restorations, or fractures in the anterior teeth
  • Patients who had separate arch debondings with a difference of more than 2 months in-between jaws

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Salma A daabis, BDS

    Minia University

    PRINCIPAL INVESTIGATOR

  • Ahmed Sh Hashem, Professor

    Minia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Salma A Daabis, BDS

CONTACT

+201066600270salma.daabis@pua.edu.eg

Ahmed Sh Hashem, Professor

CONTACT

+201002024437ahmedshawkydent@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1:1 ratio into three parallel groups to receive either a conventional multistranded stainless steel fixed retainer, a 3D-printed Cobalt-Chromium fixed retainer, or a 3D-printed Titanium Grade 5 fixed retainer.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 28, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

No plan to share individual participant data (IPD).