Malocclusion, Angle's ClassmalocclusionNCT06244810
Comparison of Two Types of Lingual Fixed Retainer Fabricated
A study testing Lingual retainer from Fiber, Lingual retainer from metal and Traditional retianer from braided in people with Malocclusion, Angle's Class, run by Hama University at 1 site in Syria.
Trial summary
This study includes patients who have had previous orthodontic treatments (without tooth extraction) and who have good alignment of their lower incisors. Investigators will compare two types of lingual retainers made with CAD-CAM Read more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- Malocclusion, Angle's Class
- What is being tested?
- Lingual retainer from Fiber, Lingual retainer from metal and Traditional retianer from braided
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSyria
- Study dates
- 15 Feb 2025to 10 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with mixed dentition at age 14-24 years. They have a good alignment of the lower incisors.- Have good oral and periodontal health.-
Who cannot join
- Patients who have a deep bite Patients who have previously used retainer Patients with poor oral care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Types of Lingual Fixed Retainer (Metal and Fiber)Fabricated by Using (CAD\CAM)Technique
This study includes patients who have had previous orthodontic treatments (without tooth extraction) and who have good alignment of their lower incisors. Investigators will compare two types of lingual retainers made with CAD-CAM
Read the detailed description
This study includes patients who have had previous orthodontic treatments (without tooth extraction) and who have good alignment of their lower incisors. Investigator will compare two types of lingual retainers made with CAD-CAM by comparing them with the traditional lingual retainers according to the following groups:
- Patients will be apply to them a lingual retainer made of fibers manufactured using CAD-CAM technology
- Patients will be apply to them a lingual retainer made of metal made using CAD-CAM technology
- Patients will be apply to them a conventional lingual retainer made of braided stainless steel wire (control group)
- Conditions
- Malocclusion, Angle's Class
- Being tested
- Lingual retainer from Fiber, Lingual retainer from metal, Traditional retianer from braided
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lingual retainer from FiberDevice
lingual retainer manufactured from fiber using CAD-CAM technique applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months.
Lingual retainer from metalDevice
lingual retainer manufactured from metal using CAD-CAM technique applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months.
Traditional retianer from braidedDevice
lingual retainer manufactured using traditional technique from stainless steel applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| lingual retainer made of fiber made using cad cam Technique | Experimental | lingual retainer made of fiber manufactured using CAD-CAM technique applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months. Receives: Device: Lingual retainer from Fiber |
| lingual retainer made of metal made using cad cam Technique | Experimental | lingual retainer made of metal manufactured using CAD-CAM technique applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months Receives: Device: Lingual retainer from metal |
| Traditional lingual retainer made of braided stainless steel wire | Experimental | lingual retainer made of braided stainless steel wire applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months. Receives: Device: Traditional retianer from braided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial plaque indicator
the amount of plaque on the gingival edge on the tooth surface is determined by using a probe. This indicator does not need to color the plaque. This indicator is taken for all teeth monthly over a period of 6 months
Measured: 6 months
Patient Acceptance Assessment:
Patient acceptance will be evaluated according to a set of questions presented in a questionnaire sheet for each patient in the hospital
Each period of the review where patient acceptance was recorded in three aspects:
- Speech: The extent of the effect of the affixed fixative on the patient's comfort with speech will be recorded in each follow-up period in the event that there is no difficulty in speaking or there is difficulty in speaking. Is there a proven effect on speech? )Yes No(
- Oral Care Procedures: The patient's ability to perform oral care procedures will be recorded In my case, the ease and difficulty of doing oral care procedures. How easy is it for you to perform oral care procedures? (easy / hard)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start15 Feb 2025
- Primary completion9 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle's ClassStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hama University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manar A Warrar, MSc, Principal investigator, Hama University-Syrian Arab RepublicRabab Alsabbagh, Professor, Study chair, Professor of Orthodontics, University of Hama Dental School, Hama, Syria.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244810
- Sponsor's protocol ID
- Hama University -Dentistry
- Acronym
- malocclusion
- Status last verified
- Mar 2025
- First submitted
- 22 Jan 2024
- Last updated
- 12 Mar 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 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Types of Lingual Fixed Retainer (Metal and Fiber)Fabricated by Using (CAD\CAM)Technique
- ClinicalTrials.gov ID
- NCT06244810
- Acronym / sponsor ID
- malocclusion / Hama University -Dentistry
- Conditions
- Malocclusion, Angle's Class
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hama UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 9 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 6 Feb 2024 (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 study includes patients who have had previous orthodontic treatments (without tooth extraction) and who have good alignment of their lower incisors. Investigators will compare two types of lingual retainers made with CAD-CAM
Detailed description
This study includes patients who have had previous orthodontic treatments (without tooth extraction) and who have good alignment of their lower incisors. Investigator will compare two types of lingual retainers made with CAD-CAM by comparing them with the traditional lingual retainers according to the following groups:
- Patients will be apply to them a lingual retainer made of fibers manufactured using CAD-CAM technology
- Patients will be apply to them a lingual retainer made of metal made using CAD-CAM technology
- Patients will be apply to them a conventional lingual retainer made of braided stainless steel wire (control group)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lingual retainer made of fiber made using cad cam Technique | Experimental | Device: Lingual retainer from Fiberlingual retainer made of fiber manufactured using CAD-CAM technique applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months. |
| lingual retainer made of metal made using cad cam Technique | Experimental | Device: Lingual retainer from metallingual retainer made of metal manufactured using CAD-CAM technique applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months |
| Traditional lingual retainer made of braided stainless steel wire | Experimental | Device: Traditional retianer from braidedlingual retainer made of braided stainless steel wire applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with mixed dentition at age 14-24 years. They have a good alignment of the lower incisors.- Have good oral and periodontal health.-
Key exclusion criteria (1 listed)
- Patients who have a deep bite Patients who have previously used retainer Patients with poor oral care
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 |
|---|---|---|
| Lingual retainer from Fiberlingual retainer manufactured from fiber using CAD-CAM technique applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months. | Device | lingual retainer made of fiber made using cad cam Technique |
| Lingual retainer from metallingual retainer manufactured from metal using CAD-CAM technique applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months. | Device | lingual retainer made of metal made using cad cam Technique |
| Traditional retianer from braidedlingual retainer manufactured using traditional technique from stainless steel applied to the lingual surfaces of the mandibular incisors and evaluated every month over a period of 6 months. | Device | Traditional lingual retainer made of braided stainless steel wire |
Primary outcome
Bacterial plaque indicator
Time frame: 6 months
the amount of plaque on the gingival edge on the tooth surface is determined by using a probe. This indicator does not need to color the plaque. This indicator is taken for all teeth monthly over a period of 6 months
Patient Acceptance Assessment:
Time frame: 6 months
Patient acceptance will be evaluated according to a set of questions presented in a questionnaire sheet for each patient in the hospital Each period of the review where patient acceptance was recorded in three aspects: 1. Speech: The extent of the effect of the affixed fixative on the patient's comfort with speech will be recorded in each follow-up period in the event that there is no difficulty in speaking or there is difficulty in speaking. Is there a proven effect on speech? )Yes No( 2. Oral Care Procedures: The patient's ability to perform oral care procedures will be recorded In my case, the ease and difficulty of doing oral care procedures. How easy is it for you to perform oral care procedures? (easy / hard)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Malocclusion, Angle's Class
Not yet recruiting
Accuracy and Periodontal Outcomes of Three Interproximal Enamel Reduction Techniques During Clear Aligner Therapy
Dental Crowding,Interproximal Enamel Reduction, Malocclusion, Angle's Class
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. This study is not recruiting at the moment.
Manar A Warrar, MSc principal investigator
Hama University-Syrian Arab Republic
Rabab Alsabbagh, Professor study chair
Professor of Orthodontics, University of Hama Dental School, Hama, Syria.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lingual retainer from Fiber, Lingual retainer from metal and Traditional retianer from braided in people with Malocclusion, Angle's Class, run by Hama University at 1 site in Syria.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Mar 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 Syria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial plaque indicator (time frame: 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 Mar 2025.