Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers

Официальное название

The Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers: A Randomized Clinical Trial

Обзор

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.

Вмешательства

• Устройство 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
• Устройство 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

Первичные конечные точки

• Change in mandibular incisor alignment (Little's Irregularity Index, ΔLII) [Срок оценки: Baseline (T0) to 6 months after retainer placement (assessed at 1, 3, and 6 months)]
• Time to first fixed-retainer failure (survival) [Срок оценки: From retainer placement to 6 months after placement.]

Вторичные конечные точки (8)

• Plaque accumulation at mandibular anterior teeth (Silness-Löe Plaque Index) [Срок оценки: Baseline and 1, 3, and 6 months.]
• Microbiological plaque outcome [Срок оценки: Follow-up visits at 1 month (T1), 3 months (T2), and 6 months (T3) after retainer placement.]
• Change in mandibular inter-canine width [Срок оценки: 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) [Срок оценки: Baseline and 1, 3, and 6 months after retainer placement.]
• Probing pocket depth at mandibular anterior teeth [Срок оценки: Baseline and 1, 3, and 6 months after retainer placement.]
• Change in mandibular arch length [Срок оценки: Baseline (T0, before retainer placement) and 1, 3, and 6 months (T1, T2, T3) after retainer placement.]
• Change in overjet [Срок оценки: Baseline (T0, before retainer placement) and 1, 3, and 6 months (T1, T2, T3) after retainer placement.]
• Change in overbite [Срок оценки: Baseline (T0, before retainer placement) and 1, 3, and 6 months (T1, T2, T3) after retainer placement.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Ирак · 1 центр

• College of Dentistry, University of Baghdad - Orthodontic Clinics — Baghdad

Идентификаторы

NCT: NCT07280455 · UOB-RCT-ORTHO-GOLDSS-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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