Actively Recruiting
Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers
Led by Noor Sattar Raheem · Updated on 2025-12-12
40
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 15 to 30 years
- Completed orthodontic treatment with well-aligned lower front teeth (Little's Irregularity Index 60.5 mm) at debond
- Good oral hygiene and healthy periodontium at baseline
- No previous bonded retainer
- All lower front teeth (canine to canine) present with sound lingual enamel suitable for bonding
You will not qualify if you...
- History of rapid maxillary expansion (RME) or surgically assisted RME (SARME)
- Presence of cleft lip and/or palate or craniofacial anomalies
- Marked deep overbite and/or parafunctional habits such as bruxism or clenching
- Conditions preventing reliable bonding in the lower front teeth (active caries, extensive restorations, enamel fractures) or missing teeth from canine to canine
- Medical or periodontal conditions likely to affect gum health (e.g., active periodontitis, uncontrolled systemic disease)
AI-Screening
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Trial Site Locations
Total: 1 location
1
College of Dentistry, University of Baghdad - Orthodontic Clinics
Baghdad, Baghdad Governorate, Iraq
Actively Recruiting
Research Team
N
NOOR Raheem, BDS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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