Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gold-coated fixed retainer wire, Stainless steel fixed retainer wire.
- Who it may be relevant to
- Registry conditions: Orthodontic Retention Appliance, Orthodontic Relapse. Basic parameters: 15 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers: A Randomized Clinical Trial
Overview
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.
Interventions
- Device Gold-coated fixed retainer wire
Participants will receive a bonded mandibular fixed retainer extending canine-to-canine. The retainer will be fabricated using a gold-coated retainer wire and bonded to the lingual surfaces of the mandibular anterior teeth using standard orthodontic bonding procedures. After placement, participants will be followed at scheduled visits (baseline and follow-ups at 1 month, 3 months, and 6 months) to evaluate clinical stability and retainer performance. At each follow-up visit, the retainer will be - Device Stainless steel fixed retainer wire
Participants will receive a bonded mandibular fixed retainer extending canine-to-canine. The retainer will be fabricated using a conventional stainless steel retainer wire and bonded to the lingual surfaces of the mandibular anterior teeth using standard orthodontic bonding procedures. After placement, participants will be followed at scheduled visits (baseline and follow-ups at, 1 month, 3 months, and 6 months) to evaluate clinical stability and retainer performance. At each follow-up visit, th
Primary outcome measures
- Change in mandibular incisor alignment (Little's Irregularity Index, ΔLII) [Time frame: Baseline (T0) to 6 months after retainer placement (assessed at 1, 3, and 6 months)]
- Time to first fixed-retainer failure (survival) [Time frame: From retainer placement to 6 months after placement.]
Secondary outcome measures (8)
- Plaque accumulation at mandibular anterior teeth (Silness-Löe Plaque Index) [Time frame: Baseline and 1, 3, and 6 months.]
- Microbiological plaque outcome [Time frame: Follow-up visits at 1 month (T1), 3 months (T2), and 6 months (T3) after retainer placement.]
- Change in mandibular inter-canine width [Time frame: Baseline (T0, before retainer placement) and follow-up visits at 1 month (T1), 3 months (T2), and 6 months (T3).]
- Gingival inflammation at mandibular anterior teeth (Löe-Silness Gingival Index) [Time frame: Baseline and 1, 3, and 6 months after retainer placement.]
- Probing pocket depth at mandibular anterior teeth [Time frame: Baseline and 1, 3, and 6 months after retainer placement.]
- Change in mandibular arch length [Time frame: Baseline (T0, before retainer placement) and 1, 3, and 6 months (T1, T2, T3) after retainer placement.]
- Change in overjet [Time frame: Baseline (T0, before retainer placement) and 1, 3, and 6 months (T1, T2, T3) after retainer placement.]
- Change in overbite [Time frame: Baseline (T0, before retainer placement) and 1, 3, and 6 months (T1, T2, T3) after retainer placement.]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Iraq · 1 center
- College of Dentistry, University of Baghdad - Orthodontic Clinics — Baghdad
Identifiers
NCT: NCT07280455 · UOB-RCT-ORTHO-GOLDSS-2025