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CompletedNCT06244810malocclusionUpdated Mar 12, 2025

Comparison of Two Types of Lingual Fixed Retainer Fabricated

An interventional study of Lingual retainer from Fiber and Lingual retainer from metal in Malocclusion, Angle's Class, sponsored by Hama University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 14 Years to 24 Years. Per ClinicalTrials.gov, last updated 2025-03-12.

Sponsored by Hama University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
14 Years to 24 Years
Sex
All
01

Study summary

This study includes patients who have had previous orthodontic treatments (without tooth extraction) and who have good alignment of their lower incisors. Investigators will compare two types of lingual retainers made with CAD-CAM

Read the detailed description

This study includes patients who have had previous orthodontic treatments (without tooth extraction) and who have good alignment of their lower incisors. Investigator will compare two types of lingual retainers made with CAD-CAM by comparing them with the traditional lingual retainers according to the following groups:

  1. Patients will be apply to them a lingual retainer made of fibers manufactured using CAD-CAM technology
  2. Patients will be apply to them a lingual retainer made of metal made using CAD-CAM technology
  3. Patients will be apply to them a conventional lingual retainer made of braided stainless steel wire (control group)
02

Conditions studied

  • Malocclusion, Angle's Class

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03

In context

Malocclusion

457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.

This study's enrollment of 42 is above the median of 36 across 372 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Hama University is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with mixed dentition at age 14-24 years. They have a good alignment of the lower incisors.- Have good oral and periodontal health.-

Exclusion criteria

Exclusion Criteria:

Patients who have a deep bite Patients who have previously used retainer Patients with poor oral care

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    lingual retainer made of fiber made using cad cam Technique

    lingual retainer made of fiber manufactured using CAD-CAM technique applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months.

    Device: Lingual retainer from Fiber

  • Experimental
    lingual retainer made of metal made using cad cam Technique

    lingual retainer made of metal manufactured using CAD-CAM technique applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months

    Device: Lingual retainer from metal

  • Experimental
    Traditional lingual retainer made of braided stainless steel wire

    lingual retainer made of braided stainless steel wire applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months.

    Device: Traditional retianer from braided

Interventions

  • DeviceLingual retainer from Fiber

    lingual retainer manufactured from fiber using CAD-CAM technique applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months.

  • DeviceLingual retainer from metal

    lingual retainer manufactured from metal using CAD-CAM technique applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months.

  • DeviceTraditional retianer from braided

    lingual retainer manufactured using traditional technique from stainless steel applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months.

06

What researchers measure

Primary outcomes

  1. Bacterial plaque indicator

    the amount of plaque on the gingival edge on the tooth surface is determined by using a probe. This indicator does not need to color the plaque. This indicator is taken for all teeth monthly over a period of 6 months

    Time frame: 6 months

  2. Patient Acceptance Assessment:

    Patient acceptance will be evaluated according to a set of questions presented in a questionnaire sheet for each patient in the hospital Each period of the review where patient acceptance was recorded in three aspects: 1. Speech: The extent of the effect of the affixed fixative on the patient's comfort with speech will be recorded in each follow-up period in the event that there is no difficulty in speaking or there is difficulty in speaking. Is there a proven effect on speech? )Yes No( 2. Oral Care Procedures: The patient's ability to perform oral care procedures will be recorded In my case, the ease and difficulty of doing oral care procedures. How easy is it for you to perform oral care procedures? (easy / hard)

    Time frame: 6 months

07

Study locations

1 site
  • FADI Alhaji JNAID
    Damascus, None Selected 123, Syrian Arab Republic
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06244810
Lead sponsor
Hama University
Responsible party
Sponsor
First posted
Feb 6, 2024
Start date
Feb 15, 2025
Primary completion
Mar 9, 2025
Completion
Mar 10, 2025
Last update
Mar 12, 2025

Study contacts

Manar A Warrar, MSc
principal investigator · Hama University-Syrian Arab Republic
Rabab Alsabbagh, Professor
study chair · Professor of Orthodontics, University of Hama Dental School, Hama, Syria.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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