Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-30
SponsorNoor Sattar Raheem
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Gold-coated fixed retainer wire
- Stainless steel fixed retainer wire
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Noor Sattar Raheem
Lead sponsor
University of Baghdad
Sponsor institution
Source ClinicalTrials.gov