Clinical Trial

Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers

Recruiting
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Summary
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.
Trial Details
NCT Number NCT07280455
Lead Sponsor Noor Sattar Raheem
Conditions Orthodontic Retention Appliance, Orthodontic Relapse
Enrollment 40 participants
Start Date 2025-11-01
Primary Completion 2026-10 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-12