Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers

NCT ID: NCT07280455

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-12-31

Brief Summary

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

Orthodontic Retention Appliance; Orthodontic Relapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Gold-coated fixed retainer wire

Participants will receive a mandibular canine-to-canine fixed retainer fabricated and bonded using the standardized protocol. The allocated device is a 0.0195-inch gold-plated multistranded wire (penta twist, five-strand).

Group Type: EXPERIMENTAL

Gold-coated fixed retainer wire

Intervention Type: DEVICE

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 clinically examined for integrity, and any failure/complication events will be recorded (e.g., debonding/loosening, fracture, or need for repair). Clinical outcome assessments will include mandibular anterior alignment/stability (Little's Irregularity Index), periodontal indices, and occlusal assessment, Microbiological sampling will consist of plaque/swab samples collected at each follow-up visit.

Stainless steel fixed retainer wire

Participants will receive a mandibular canine-to-canine fixed retainer fabricated and bonded using the standardized protocol. The allocated device is a 0.0195-inch dead-soft multistranded stainless-steel wire (coaxial, six-strand).

Group Type: ACTIVE_COMPARATOR

Stainless steel fixed retainer wire

Intervention Type: DEVICE

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, the retainer will be clinically examined for integrity, and any failure/complication events will be recorded (e.g., debonding/loosening, fracture, or need for repair). Clinical outcome assessments will include mandibular anterior alignment/stability (Little's Irregularity Index), periodontal indices, and occlusal assessment. Microbiological sampling will consist of plaque/swab samples collected at each follow-up visit.

Interventions

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 clinically examined for integrity, and any failure/complication events will be recorded (e.g., debonding/loosening, fracture, or need for repair). Clinical outcome assessments will include mandibular anterior alignment/stability (Little's Irregularity Index), periodontal indices, and occlusal assessment, Microbiological sampling will consist of plaque/swab samples collected at each follow-up visit.

Intervention Type: 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, the retainer will be clinically examined for integrity, and any failure/complication events will be recorded (e.g., debonding/loosening, fracture, or need for repair). Clinical outcome assessments will include mandibular anterior alignment/stability (Little's Irregularity Index), periodontal indices, and occlusal assessment. Microbiological sampling will consist of plaque/swab samples collected at each follow-up visit.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Noor Sattar Raheem

OTHER

Sponsor Role: lead

Responsible Party

Noor Sattar Raheem

Postgraduate Researcher (Principal Investigator)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

NOOR NOOR, BDS

Role: PRINCIPAL_INVESTIGATOR

noor sattar

Locations

College of Dentistry, University of Baghdad - Orthodontic Clinics

Baghdad, Baghdad Governorate, Iraq

Site Status: RECRUITING

Countries

Iraq

Central Contacts

NOOR Raheem, BDS

Role: CONTACT

Noor.sattar2403@codental.uobaghdad.edu.iq

+9647704514927

Facility Contacts

NOOR Raheem, BDS

Role: primary

Noor.sattar2403@codental.uobaghdad.edu.iq

+9647704514927

Other Identifiers

UOB-RCT-ORTHO-GOLDSS-2025

Identifier Type: -

Identifier Source: org_study_id