Comparison of Two Types of Lingual Fixed Retainer Fabricated

NCT06244810 | Completed

• 1 other identifier: Hama University -Dentistry
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Malocclusion, Angle's Class

Outcome Measures

Primary Outcomes (2)

• 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

• 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)

  6 months

Study Arms (3)

lingual retainer made of fiber made using cad cam Technique

EXPERIMENTAL

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 made of metal made using cad cam Technique

EXPERIMENTAL

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

Traditional lingual retainer made of braided stainless steel wire

EXPERIMENTAL

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

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 made of fiber made using cad cam Technique

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.

lingual retainer made of metal made using cad cam Technique

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.

Traditional lingual retainer made of braided stainless steel wire

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hama University: lead

Study Sites (1)

FADI Alhaji JNAID

Damascus, None Selected, 123, Syria

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Manar A Warrar, MSc

  Hama University-Syrian Arab Republic

  PRINCIPAL INVESTIGATOR

• Rabab Alsabbagh, Professor

  Professor of Orthodontics, University of Hama Dental School, Hama, Syria.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 6, 2024
• Study Start: February 15, 2025
• Primary Completion: March 9, 2025
• Study Completion: March 10, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)