Survival Rate of Two Types of Multistranded Fixed Retainers

NCT07476950 | Active Not Recruiting

• 1 other identifier: KB/956/14
• Study Type: interventional
• Target: 133
• Locations: 0 countries
• Sites: N/A

Brief Summary

• gum and periodontal health
• stability of tooth alignment after treatment.
• Who can participate?
• 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.
• 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.
• Round twisted wire retainer (3-strand stainless steel wire)
• 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.
• 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

Keywords

bonded retainer; fixed retainer,; orthodontic retention; periodontal status; satisfaction; stability; survival

Outcome Measures

Primary Outcomes (1)

• Survival rate

  The survival rate of the fixed mandibular anterior retainer will be defined as the proportion of retainers that remain intact and functional without failure during the follow-up period. Retainer failure will be recorded when any of the following events occurs: (1) debonding of the retainer from one or more teeth, (2) fracture of the retainer wire, (3) simultaneous fracture and debonding, or (4) complete loss of the retainer. Retainer integrity will be assessed during scheduled clinical examinations, and the date and type of failure will be documented when detected.

  Up to 24 months after retainer placement (assessed at baseline, 3, 6, 12, 18, and 24 months).

Secondary Outcomes (12)

• Patient comfort and satisfaction

  Assessed at baseline (retainer placement) and during follow-up visits at 3, 6, 12, 18, and 24 months after retainer placement.

• Periodontal health - Periodontal Index

  Baseline; 3, 6, 12, 18, and 24 months after retainer placement.

• Periodontal health - Bleeding on Probing (BoP)

  Baseline; 3, 6, 12, 18, and 24 months after retainer placement.

• Periodontal health - Plaque Index

  Baseline; 3, 6, 12, 18, and 24 months after retainer placement.

• Periodontal health - Gingival Index

  Baseline; 3, 6, 12, 18, and 24 months after retainer placement.

Study Arms (2)

Round twisted wire

EXPERIMENTAL

Patients are privided with 0.0215-inch stainless steel three-strand round twisted wire retainer (Ortho Organizers, Lindenberg, Germany)

Device: Placement of round twisted retainer wire

Rectangular braided wire

ACTIVE COMPARATOR

Patients are privided with 0.0265 inch × 0.0106 inch eight-strand Bond-a-Braid wire retainer (Reliance Orthodontic Products, Itasca, IL, USA)

Device: Placement of rectangular braided retainer wire

Interventions

Placement of round twisted retainer wire DEVICE

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.

Round twisted wire

Placement of rectangular braided retainer wire DEVICE

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

Rectangular braided wire

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age at debonding,
• all mandibular permanent incisors and canines present,
• no active caries, no restorations, no fractures on the mandibular incisors and canines,
• no periodontal disease;
• retention plan including only retainer bonded from 3 to 3

You may not qualify if:

• inadequate hygiene,
• need for restorative or surgical treatment,
• active periodontal disease,
• removable retainer as adjunct to a bonded retainer

Sponsors & Collaborators

• Piotr Fudalej: lead

Related Publications (5)

• Pandis N, Fleming PS, Kloukos D, Polychronopoulou A, Katsaros C, Eliades T. Survival of bonded lingual retainers with chemical or photo polymerization over a 2-year period: a single-center, randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2013 Aug;144(2):169-75. doi: 10.1016/j.ajodo.2013.02.030.

  PMID: 23910197 BACKGROUND

• Pazera P, Fudalej P, Katsaros C. Severe complication of a bonded mandibular lingual retainer. Am J Orthod Dentofacial Orthop. 2012 Sep;142(3):406-9. doi: 10.1016/j.ajodo.2012.01.019.

  PMID: 22920708 BACKGROUND

• Pandis N, Vlahopoulos K, Madianos P, Eliades T. Long-term periodontal status of patients with mandibular lingual fixed retention. Eur J Orthod. 2007 Oct;29(5):471-6. doi: 10.1093/ejo/cjm042.

  PMID: 17974536 BACKGROUND

• Booth FA, Edelman JM, Proffit WR. Twenty-year follow-up of patients with permanently bonded mandibular canine-to-canine retainers. Am J Orthod Dentofacial Orthop. 2008 Jan;133(1):70-6. doi: 10.1016/j.ajodo.2006.10.023.

  PMID: 18174074 BACKGROUND

• Artun J, Spadafora AT, Shapiro PA. A 3-year follow-up study of various types of orthodontic canine-to-canine retainers. Eur J Orthod. 1997 Oct;19(5):501-9. doi: 10.1093/ejo/19.5.501.

  PMID: 9386336 BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Piotr FUdalej

  Jagiellonian University in Krakow

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 17, 2026
• Study Start: December 1, 2014
• Primary Completion: July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share