Gold-plated versus stainless-steel fixed retainers for lower front teeth
The Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers: A Randomized Clinical Trial
NA · University of Baghdad · NCT07280455
This trial will test whether a gold-plated or a stainless-steel fixed retainer better keeps the lower front teeth aligned in people aged 15–30 who have just finished orthodontic treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 15 Years to 30 Years |
| Sex | All |
| Sponsor | University of Baghdad (other) |
| Locations | 1 site (Baghdad, Baghdad Governorate) |
| Trial ID | NCT07280455 on ClinicalTrials.gov |
What this trial studies
This randomized, single-center trial will allocate post-orthodontic patients 1:1 to receive a 0.0195-inch multistranded gold-plated mandibular fixed retainer or an identical-gauge stainless-steel retainer. Eligible participants are aged 15–30 with well-aligned mandibular anterior teeth, healthy periodontium, and no prior bonded retainer, and they will be followed for six months with scheduled clinical visits. The primary outcomes are change in Little's Irregularity Index to quantify anterior alignment and retainer failure metrics such as time to first failure and tooth-level failure events. Secondary measures include periodontal health indices and microbiological plaque sampling to explore differences in tissue response or biofilm formation.
Who should consider this trial
Good fit: Ideal candidates are people aged 15–30 who have completed comprehensive orthodontic treatment with well-aligned lower front teeth, good oral hygiene, a healthy periodontium, and no previous bonded mandibular retainer.
Not a fit: Patients with poor oral hygiene, active periodontal disease, missing or heavily restored mandibular anterior teeth, marked deep overbite, parafunctional habits, or craniofacial anomalies are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, a gold-plated retainer could better maintain lower front tooth alignment and reduce retainer failures, lowering the need for additional orthodontic treatment.
How similar studies have performed: Comparable fixed-retainer materials have been examined previously, but gold-plated wire has limited clinical data and has not been clearly shown superior in prior reports.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Baghdad, Baghdad Governorate
- College of Dentistry, University of Baghdad - Orthodontic Clinics — Baghdad, Baghdad Governorate, Iraq (RECRUITING)
Study contacts
- Principal investigator: NOOR NOOR, BDS — noor sattar
- Study coordinator: NOOR Raheem, BDS
- Email: Noor.sattar2403@codental.uobaghdad.edu.iq
- Phone: +9647704514927
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Orthodontic Retention Appliance, Orthodontic Relapse, fixed retainer, gold-coated retainer wire, stainless steel retainer wire, Little's Irregularity Index, retainer failure, periodontal indices