Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers

Noor Sattar Raheem

Status: Enrolling

Conditions: Orthodontic Relapse; Orthodontic Retention Appliance

Treatments: Device: Stainless steel fixed retainer wire; Device: Gold-coated fixed retainer wire

Study type: Interventional

Funder types: Other

Identifiers

NCT07280455

UOB-RCT-ORTHO-GOLDSS-2025

Details and patient eligibility

About

This randomized clinical trial will compare the effectiveness of a gold-plated multistranded mandibular fixed retainer versus a conventional multistranded stainless-steel fixed retainer in maintaining lower anterior tooth alignment after completion of orthodontic treatment. Eligible participants (post-orthodontic patients requiring mandibular fixed retention) will be allocated in a 1:1 ratio to receive either a gold-plated 0.0195-inch multistranded retainer or an identical-gauge 0.0195-inch stainless-steel multistranded retainer. Participants will be followed for 6 months.

The primary outcome is post-treatment stability of mandibular anterior alignment, assessed by changes in Little's Irregularity Index over time, along with retainer failure outcomes (e.g., time to first failure and tooth-level failure events). Secondary outcomes include periodontal health indices and related clinical measures collected at baseline and follow-up visits.

For the microbiological assessment, plaque/biofilm will be collected from the retainer using sterile swabs at 1 month, 3 months, and 6 months to evaluate bacterial levels associated with each retainer material.

Enrollment: 40 estimated patients

Sex: All

Ages: 15 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 15-30 years.
• Patients who have completed comprehensive orthodontic treatment ,with well-aligned mandibular anterior teeth (Little's Irregularity Index ≤ 0.5 mm) at debond; both extraction and non-extraction cases are eligible.
• Patients with good oral hygiene and healthy periodontium at baseline; no previous bonded retainer.
• All mandibular anterior teeth present (canine-canine), with sound lingual enamel suitable for bonding.

Exclusion criteria

• Patients with a history of rapid maxillary expansion (RME) or surgically assisted RME (SARME).
• Patients with a cleft lip / and or palate (craniofacial anomalies).
• Patients with marked deep overbite and/or parafunctional habits (e.g., bruxism, clenching).
• Patients with conditions precluding reliable bonding in the mandibular anterior segment (active caries, extensive restorations, enamel fractures) or missing teeth from canine to canine.
• Patients with medical/periodontal conditions likely to affect gingival health (e.g., active periodontitis, uncontrolled systemic disease).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Gold-coated fixed retainer wire

Experimental group

Description:

Participants will receive a mandibular canine-to-canine fixed retainer fabricated and bonded using the standardized protocol. The allocated device is a 0.0195-inch gold-plated multistranded wire (penta twist, five-strand).

Treatment:

Device: Gold-coated fixed retainer wire

Stainless steel fixed retainer wire

Active Comparator group

Description:

Participants will receive a mandibular canine-to-canine fixed retainer fabricated and bonded using the standardized protocol. The allocated device is a 0.0195-inch dead-soft multistranded stainless-steel wire (coaxial, six-strand).

Treatment:

Device: Stainless steel fixed retainer wire