Comparison of Two Types of Lingual Fixed Retainer Fabricated

Malocclusion, Angle's Class Clinical Trial

— malocclusion  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06244810
• Other study ID #: Hama University -Dentistry
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: November 2023
• Source: Hama University
• Contact: FADI JNAID, Associate Pro
• Phone: 988499015
• Email: Drfadijnaid[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle's Class

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Syrian Arab Republic	FADI Alhaji JNAID	Damascus	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Hama University

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Primary	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: 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)	6 months