Orthodontic Retention ApplianceNCT07280455
Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers
A study testing Gold-coated fixed retainer wire and Stainless steel fixed retainer wire in people with Orthodontic Retention Appliance and Orthodontic Relapse, run by Noor Sattar Raheem at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Orthodontic Retention Appliance, Orthodontic Relapse
- What is being tested?
- Gold-coated fixed retainer wire and Stainless steel fixed retainer wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 1 Nov 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
College of Dentistry, University of Baghdad - Orthodontic Clinics
Baghdad, Baghdad Governorate
NOOR Raheem, BDS, +9647704514927, Noor.sattar2403@codental.uobaghdad.edu.iq
About this study
Official title: The Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers: A Randomized Clinical 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.
- Being tested
- Gold-coated fixed retainer wire, Stainless steel fixed retainer wire
- Keywords
- fixed retainer, gold-coated retainer wire, stainless steel retainer wire, Little's Irregularity Index, retainer failure, periodontal indices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gold-coated fixed retainer wireDevice
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 wireDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Gold-coated fixed retainer wire | Experimental | 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). Receives: Device: Gold-coated fixed retainer wire |
| Stainless steel fixed retainer wire | Active comparator | 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). Receives: Device: Stainless steel fixed retainer wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mandibular incisor alignment (Little's Irregularity Index, ΔLII)
Little's Irregularity Index (LII) is a quantitative scale of mandibular anterior alignment, calculated as the sum of the linear displacements (in mm) of the contact points of the six mandibular anterior teeth. Scores range from 0 mm (perfect alignment, no irregularity) to ≥10 mm (very severe irregularity); higher scores indicate greater crowding and therefore a worse outcome.
LII will be measured for the mandibular anterior teeth (canine-to-canine) at baseline (T0, before fixed-retainer placement) and at follow-up visits (T1 = 1 month, T2 = 3 months, T3 = 6 months). The primary endpoint is the change in LII (follow-up LII minus baseline LII), comparing gold-plated versus stainless-steel fixed-retainer groups.
Measured: Baseline (T0) to 6 months after retainer placement (assessed at 1, 3, and 6 months)
Time to first fixed-retainer failure (survival)
Time (days) from fixed retainer bonding to the first failure event requiring repair/rebonding/replacement. Failures will be recorded and classified (e.g., adhesive-enamel debond, wire-composite debond, wire fracture, partial/complete loosening) and compared between groups.
Measured: From retainer placement to 6 months after placement.
Secondary outcomes (8)
Plaque accumulation at mandibular anterior teeth (Silness-Löe Plaque Index)
Silness-Löe Plaque Index is a 4-point scale (0-3) that scores plaque accumulation on tooth surfaces adjacent to the gingival margin. Scores range from 0 (no plaque) to 3 (abundant soft deposits); higher scores indicate poorer oral hygiene and a worse periodontal condition. The mean Plaque Index will be recorded for the mandibular anterior teeth adjacent to the fixed retainer at baseline (T0, before retainer placement) and at 1 month (T1), 3 months (T2), and 6 months (T3) after retainer placement, and compared between the gold-plated and stainless-steel fixed-retainer groups.
Measured: Baseline and 1, 3, and 6 months.
Microbiological plaque outcome
Biofilm will be collected using a sterile swab moved along interdental spaces over the exposed retainer, then placed in transport medium and sent for cultivation. After incubation on agar, the total number of bacterial colonies (colony-forming units, CFU) will be counted for each sample. Higher CFU counts indicate greater plaque accumulation and a worse periodontal outcome. Samples will be collected at 1 month (T1), 3 months (T2), and 6 months (T3) after retainer placement and compared between the gold-plated and stainless-steel fixed-retainer groups.
Measured: Follow-up visits at 1 month (T1), 3 months (T2), and 6 months (T3) after retainer placement.
Change in mandibular inter-canine width
Mandibular inter-canine width (mm) will be measured on study casts/impressions as the linear distance between the cusp tips of the right and left mandibular canines. Measurements will be taken at baseline (T0, before fixed-retainer placement) and at 1 month (T1), 3 months (T2), and 6 months (T3) after retainer placement. The outcome is the change in inter-canine width from baseline at each follow-up visit; larger absolute changes indicate greater relapse and worse post-treatment occlusal stability. Changes will be compared between the gold-plated and stainless-steel fixed-retainer groups.
Measured: 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)
Gingival condition will be assessed using the Löe-Silness Gingival Index, a 4-point scale (0-3) where 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, and 3 = severe inflammation with ulceration and/or spontaneous bleeding. Higher scores indicate more severe gingival inflammation and a worse periodontal outcome. The mean Gingival Index will be recorded for the mandibular anterior teeth adjacent to the fixed retainer at baseline (T0) and at 1 month (T1), 3 months (T2), and 6 months (T3) after retainer placement, and compared between the two retainer groups.
Measured: Baseline and 1, 3, and 6 months after retainer placement.
Probing pocket depth at mandibular anterior teeth
Probing pocket depth (PPD) in millimeters will be measured at specified sites around the mandibular anterior teeth using a calibrated periodontal probe. Higher values indicate deeper pockets and a worse periodontal outcome. Mean PPD will be calculated for the mandibular anterior region at baseline (T0) and at 1 month (T1), 3 months (T2), and 6 months (T3) after retainer placement, and compared between the two fixed-retainer groups.
Measured: Baseline and 1, 3, and 6 months after retainer placement.
Change in mandibular arch length
Mandibular arch length (mm) will be measured on study casts as the linear distance from the mesial surface of the right mandibular first permanent molar to the mesial surface of the left mandibular first permanent molar, parallel to the occlusal plane. Measurements will be taken at baseline (T0, before fixed-retainer placement) and at 1 month (T1), 3 months (T2), and 6 months (T3) after retainer placement. The outcome is the change in arch length from baseline at each follow-up visit; larger absolute changes indicate greater relapse and worse post-treatment occlusal stability. Changes will be compared between the gold-plated and stainless-steel fixed-retainer groups.
Measured: Baseline (T0, before retainer placement) and 1, 3, and 6 months (T1, T2, T3) after retainer placement.
Change in overjet
Overjet (mm) will be measured as the horizontal distance between the labial surface of the most prominent mandibular incisor and the palatal surface of the corresponding maxillary incisor, measured on study casts and/or intraoral records. Measurements will be taken at baseline (T0, before fixed-retainer placement) and at 1 month (T1), 3 months (T2), and 6 months (T3) after retainer placement. The outcome is the change in overjet from baseline at each follow-up visit; larger absolute changes indicate greater relapse and worse post-treatment occlusal stability. Changes will be compared between the gold-plated and stainless-steel fixed-retainer groups.
Measured: Baseline (T0, before retainer placement) and 1, 3, and 6 months (T1, T2, T3) after retainer placement.
Change in overbite
Overbite (mm) will be measured as the vertical overlap of the maxillary incisors over the mandibular incisors, using study casts and/or intraoral records. Measurements will be taken at baseline (T0, before fixed-retainer placement) and at 1 month (T1), 3 months (T2), and 6 months (T3) after retainer placement. The outcome is the change in overbite from baseline at each follow-up visit; larger absolute changes indicate greater relapse and worse post-treatment occlusal stability. Changes will be compared between the gold-plated and stainless-steel fixed-retainer groups.
Measured: Baseline (T0, before retainer placement) and 1, 3, and 6 months (T1, T2, T3) after retainer placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Nov 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Retention ApplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noor Sattar Raheem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noor Sattar Raheem, University of Baghdad
- Investigators
- NOOR NOOR, BDS, Principal investigator, noor sattar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280455
- Sponsor's protocol ID
- UOB-RCT-ORTHO-GOLDSS-2025
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07280455
- Acronym / sponsor ID
- UOB-RCT-ORTHO-GOLDSS-2025
- Keywords
- fixed retainer, gold-coated retainer wire, stainless steel retainer wire, Little's Irregularity Index, retainer failure, periodontal indices
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Noor Sattar RaheemUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gold-coated fixed retainer wire | Experimental | Device: Gold-coated fixed retainer wireParticipants 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). |
| Stainless steel fixed retainer wire | Active comparator | Device: Stainless steel fixed retainer wireParticipants 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). |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gold-coated fixed retainer wireParticipants 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. | Device | Gold-coated fixed retainer wire |
| Stainless steel fixed retainer wireParticipants 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. | Device | Stainless steel fixed retainer wire |
Primary outcome
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)
Little's Irregularity Index (LII) is a quantitative scale of mandibular anterior alignment, calculated as the sum of the linear displacements (in mm) of the contact points of the six mandibular anterior teeth. Scores range from 0 mm (perfect alignment, no irregularity) to ≥10 mm (very severe irregularity); higher scores indicate greater crowding and therefore a worse outcome. LII will be measured for the mandibular anterior teeth (canine-to-canine) at baseline (T0, before fixed-retainer placement) and at follow-up visits (T1 = 1 month, T2 = 3 months, T3 = 6 months). The primary endpoint is the change in LII (follow-up LII minus baseline LII), comparing gold-plated versus stainless-steel fixed-retainer groups.
Time to first fixed-retainer failure (survival)
Time frame: From retainer placement to 6 months after placement.
Time (days) from fixed retainer bonding to the first failure event requiring repair/rebonding/replacement. Failures will be recorded and classified (e.g., adhesive-enamel debond, wire-composite debond, wire fracture, partial/complete loosening) and compared between groups.
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
NOOR NOOR, BDS principal investigator
noor sattar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gold-coated fixed retainer wire and Stainless steel fixed retainer wire in people with Orthodontic Retention Appliance and Orthodontic Relapse, run by Noor Sattar Raheem at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NOOR Raheem, BDS (+9647704514927, Noor.sattar2403@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.