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Completed

NCT Number: NCT06244810

Comparison of Two Types of Lingual Fixed Retainer Fabricated

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

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Key information

Conditions

Malocclusion, Angle's Class Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FADI Alhaji JNAID

Damascus, None Selected, 123, Syria

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Lingual retainer from Fiber

Device

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.

Lingual retainer from metal

Device

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.

Traditional retianer from braided

Device

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.

Primary outcomes

  1. Bacterial plaque indicator

    Time frame: 6 months

    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

  2. Patient Acceptance Assessment:

    Time frame: 6 months

    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:

    • 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(

    • 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)

Sponsors and collaborators

Lead sponsor

Hama University

Other

Registry information

Official study title

Comparison of Two Types of Lingual Fixed Retainer (Metal and Fiber)Fabricated by Using (CAD\CAM)Technique

Acronym: malocclusion

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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