Survival Rate of Two Types of Multistranded Fixed Retainers

Summary

1. Why is this study being done? After orthodontic treatment (such as braces), teeth can move back toward their original positions. To prevent this, orthodontists use retainers during the retention phase of treatment. One common option is a fixed retainer, which is a thin wire bonded to the inside surfaces of the front teeth. Fixed retainers help keep teeth in their corrected positions for many years. There are different types of fixed retainers, and they differ in how the wire is made. However, it is still unclear which type works best and lasts the longest. Some retainers may break, come loose, or make oral hygiene more difficult.

This study aims to compare two commonly used types of fixed retainers to determine which one performs better over time.
2. What is the purpose of the study?

The main goal of this study is to find out whether the type of fixed orthodontic retainer affects how long it remains intact and functional after orthodontic treatment. The study will also evaluate whether the type of retainer influences:

\- patient comfort and satisfaction

\- ease of maintaining oral hygiene
* gum and periodontal health
* stability of tooth alignment after treatment.
3. Who can participate?

People may be eligible to participate if they:

\- are 15-50 years old

\- have completed orthodontic treatment
* have all lower front teeth present
* have healthy gums and teeth in the lower front area. Some patients will not be eligible if they have active gum disease or need additional dental treatment in the lower front teeth.
4. What will happen during the study? Participants who agree to take part will be randomly assigned to receive one of two types of fixed retainers. Random assignment means that a computer will decide which retainer each participant receives, similar to drawing lots.

The two types of retainers being compared are:

1. Round twisted wire retainer (3-strand stainless steel wire)
2. Braided rectangular wire retainer (8-strand braided wire) Both types are commonly used in orthodontic practice. 5) What will participants need to do? At the start of the study, the orthodontic appliance (braces) will be removed and the retainer will be bonded to the lower front teeth.

Participants will attend follow-up visits over two years:
* at the start of the study
* after 3, 6,12, 18, and 24 months.

During these visits, the research team will:

\- check whether the retainer is still intact

\- examine gum health
* take dental impressions and photographs
* ask participants to complete a short questionnaire about comfort and oral hygiene.

6\) What are the possible risks?

The study procedures are the same as those commonly used in routine orthodontic care. Possible minor discomforts may include:

\- mild discomfort during gum examination

\- temporary discomfort when dental impressions are taken. No additional invasive procedures are planned. 7) Are there any benefits?

Participants may benefit from:

\- regular monitoring of their retainer
* routine evaluation of gum health
* early detection of any problems with the retainer. The results of this study may help orthodontists choose the most reliable retainer for future patients.

8\) Is participation voluntary? Yes. Taking part in the study is completely voluntary. Participants may withdraw from the study at any time without affecting their orthodontic care. Personal information will be kept confidential and securely stored.

Conditions

• Orthodontic Retention

Interventions

DEVICE

Placement of round twisted retainer wire

Participants assigned to this intervention will receive a fixed mandibular lingual retainer made of a three-stranded twisted round stainless steel wire (diameter 0.0215 inches). After completion of active orthodontic treatment and removal of the fixed appliance, the retainer wire will be adapted to the lingual surfaces of the mandibular anterior teeth (canine to canine). The wire will then be bonded to each tooth using a standard orthodontic adhesive technique to provide continuous stabilization of tooth alignment during the retention phase. Prior to retainer placement, professional dental cleaning (scaling and air polishing) will be performed. The retainer will be bonded according to a standardized clinical protocol used in the study site. After placement, the integrity of the retainer will be monitored during scheduled follow-up visits to detect possible failures such as wire fracture or debonding.

DEVICE

Placement of rectangular braided retainer wire

Participants assigned to this intervention will receive a fixed mandibular lingual retainer made of an eight-stranded compressed braided stainless steel wire with a rectangular cross-section (0.008 × 0.03 inches) (Bond-a-Braid Lingual Retainer, HG Orthodontics). After completion of active orthodontic treatment and removal of the fixed orthodontic appliance, the retainer wire will be adapted to the lingual surfaces of the mandibular anterior teeth (canine to canine). The wire will be bonded to each tooth using a standard orthodontic adhesive technique to maintain tooth alignment during the retention phase. Before retainer placement, professional dental cleaning (scaling and air polishing) will be performed. The retainer will be bonded following a standardized clinical protocol applied to all participants in the study. After placement, the integrity and performance of the retainer will be evaluated during scheduled follow-up visits to identify potential failures such as debonding or wir

Sponsors & Collaborators

• Piotr Fudalej

  lead OTHER

Principal Investigators

• Piotr FUdalej · Jagiellonian University in Krakow

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-01

Primary Completion

2026-07-01

Completion

2026-12-01