Comparison of Two Types of Lingual Fixed Retainer Fabricated (malocclusion)

January 29, 2024 updated by: Hama University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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:

  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)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hama University

Investigators

  • Principal Investigator: Manar A Warrar, MSc, Hama University-Syrian Arab Republic
  • Study Chair: Rabab Alsabbagh, Professor, Professor of Orthodontics, University of Hama Dental School, Hama, Syria.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2024

Primary Completion (Estimated)

April 15, 2024

Study Completion (Estimated)

June 15, 2024

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hama University -Dentistry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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