Periodontal and Orthodontic Outcomes of Straight vs. Looped Fixed Retainers

King Abdulaziz University

Status: Enrolling

Conditions: Orthodontic Treatment; Orthodontic Appliance Design; Orthodontic Appliance Complication

Treatments: Device: V- loop Bonded Orthodontic Retainer; Device: Straight Wire Retainer

Study type: Interventional

Funder types: Other

Identifiers

NCT05644119

084-09-22

Details and patient eligibility

About

The goal of this split-mouth, head-to-head, randomized controlled trial is to compare the effects of a fixed straight retainer with the V- loop bonded retainer on periodontal health in patients with the requirement of continuous fixed retention for 12-24 months after orthodontic treatment.

The main question it aims to answer is whether the V- loop bonded retainer is more effective than fixed straight retainer for periodontal health management.

Each patient will receive 2 lower fixed and bonded retainers: (1) a straight wire retainer (SWR) and (2) a looped wire retainer (LWR). Patients will be asked to floss once daily with a thread flosser.

Researchers will compare the effects of two types of retainers to see if there is a statistically significant difference.

Full description

Ensuring alignment stability is a major challenge for orthodontists following an orthodontic treatment. This has led to the development of various orthodontic retention methods to enhance stability. Both fixed and removable retainers have been in use for years. However, most orthodontists nowadays prefer fixed bonded retainers over removable ones due to their many advantages, including easy to wear, being patient compliance free, long-term usability and stability, and better aesthetics. Over the past decades, many variations of fixed retainers have been developed. Of these, the current gold standard is the straight type flexible spiral (multistranded) wire retainer. Nevertheless, a major concern of using fixed straight retainers is the potential for periodontal health compromise. They are known to make oral hygiene maintenance more difficult for the patient, which in turn may lead to periodontal diseases due to more plaque and calculus accumulation. The wave or V- loop bonded retainer may be a solution to this problem, as it provides stability of teeth yet allows flossing with ease.

Enrollment: 50 estimated patients

Sex: All

Ages: 12 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients in need of continuous fixed retention for 12-24 months after orthodontic treatment
• Good periodontal health (i.e., no clinical attachment loss and < 10% bleeding on probing)

Exclusion criteria

• History of oral prophylaxis in the past 6 months
• History of any systemic illness such as diabetes
• Preexisting or post-orthodontic periodontal disease
• Current intake of antibiotic and/or anti-inflammatory medications
• Smoking
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

V-looped Wire Retainer (LWR)

Experimental group

Description:

The LWR is a 0.569-mm (0.022-inch) Blue Elgiloy (soft) round wire (RMO). The retainer will extend from the left canine to the right central incisor.

Treatment:

Device: V- loop Bonded Orthodontic Retainer

Straight Wire Retainer (SWR)

Active Comparator group

Description:

The SWR is 0.8-mm twisted stainless steel wire (3M Unitek, Monrovia, Calif). The retainer will extend from the right canine to the left central incisor.

Treatment:

Device: Straight Wire Retainer