Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers

Recruiting now · Not applicable

Conditions studied: Orthodontic Retention Appliance, Orthodontic Relapse

In brief

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.

Key facts

Study ID

NCT07280455

Run by

Noor Sattar Raheem

People needed

40

Starts

2025-11-01

Expected to finish

2026-12-01

Last updated by the study team

2025-12-12

Who can join

Age: 15 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• College of Dentistry, University of Baghdad - Orthodontic Clinics — Baghdad, Baghdad Governorate, Iraq (enrolling)

Full record on ClinicalTrials.gov

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