Dental CrowdingNCT07591454
Treatment Outcome of Elastomeric and Nickel-Titanium Separators in Tooth Separation
A study testing Elastomeric separators and Nickel-Titanium separators in people with Dental Crowding and Malocclusion, Angle Class I, run by 3D-Aligners.
Trial summary
Patients seeking fixed orthodontic treatment that requires band placement will be enrolled in this study. This trial aims to compare the efficiency of rectangular cross-section nickel-titanium separators with elastomeric separators in creating sufficient interdental space for orthodontic band placement. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Dental Crowding, Malocclusion, Angle Class I
- What is being tested?
- Elastomeric separators and Nickel-Titanium separators
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Feb 2027
- 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Class I skeletal and dental malocclusion.
- No history of previous orthodontic treatment.
- All permanent teeth in both arches, except third molars.
- Good oral hygiene and periodontal health.
- Good interproximal tooth contacts at the site of separator placement as
- checked by interdental floss.
- No caries or restorations on the proximal surfaces of first and second permanent molars, and second premolars.
Who cannot join
- Patients presenting with restorations or carious lesions on the proximal surfaces of the first or second molars or the second premolars.
- Patients with uncontrolled gingival or periodontal inflammation.
- Patients with a history of previous orthodontic treatment.
- Patients are skeletally classified as Class II or Class III.
- Patients are currently using opioid analgesics or have chronic pain conditions requiring regular analgesic intake.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Between The Efficiency Of Elastomeric And Nickel-Titanium Separators In Tooth Separation, Pain Perception, And Gingival Inflammation - A Randomized Controlled Trial
Patients seeking fixed orthodontic treatment that requires band placement will be enrolled in this study. This trial aims to compare the efficiency of rectangular cross-section nickel-titanium separators with elastomeric separators in creating sufficient interdental space for orthodontic band placement. In addition, the impact of both separator types on pain perception and gingival health during a 3-day placement period will be evaluated. Participants will be allocated to two groups in a split-mouth design. On the experimental side, nickel-titanium separators will be used, while elastomeric separators will be used as the control on the other side. Outcomes will include separation efficacy, pain perception over time, gingival inflammation, analgesic consumption, and separator loss.
Read the detailed description
In fixed orthodontic therapy, placement of separators is usually the first clinical step to create interdental space between posterior teeth, particularly the first molars, in preparation for orthodontic band placement. Failure to adequately separate teeth prior to banding may result in enamel damage, distortion of the band material, soft tissue injury, and increased patient discomfort. Improper band placement without sufficient separation can also lead to excessive pressure on the periodontal ligament (PDL), a risk of alveolar bone contact, and the formation of hyalinized areas within the PDL, evoking a pain response from resident mechanoreceptors. Pain is one of the primary reasons for patient dissatisfaction and discontinuation of orthodontic treatment. Therefore, identifying an ideal orthodontic separator that can produce adequate tooth separation while minimizing pain, discomfort, and gingival inflammation is of considerable clinical importance.
- Conditions
- Dental Crowding, Malocclusion, Angle Class I
- Being tested
- Elastomeric separators, Nickel-Titanium separators
- Keywords
- Orthodontic separators, Nickel-Titanium, Elastomeric, Tooth separation, Pain perception, VAS, Gingival inflammation
- Medical subject headings
- Crowding, Malocclusion, Angle Class I, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastomeric separatorsOther
application of the elastomeric separators before application of the orthodontic bands on the first molars
Nickel-Titanium separatorsOther
application of the Nickel-Titanium separators before application of the orthodontic bands on the first molars
| Study group | Role | What they receive |
|---|---|---|
| Nickle-titanium group | Experimental | Not described Receives: Other: Nickel-Titanium separators |
| elastomeric group | Active comparator | Not described Receives: Other: Elastomeric separators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perception
Pain perception will be assessed using a Visual Analogue Scale (VAS) and a standardized questionnaire. Patients will receive a pain perception worksheet containing a 100 mm horizontal VAS line for each side of the mouth. The scale will range from "no pain" to "worst pain imaginable" and will be completed during rest, biting, chewing, work/school activities, and sleep
Measured: At 4, 24, 48, and 72 hours after separator placement.
Separation efficacy
Interdental separation will be measured at the time of separator removal using a feeler gauge. A separation greater than 0.16 mm will be considered sufficient for band placement, while a separation of less than 0.16 mm will be considered insufficient.
Measured: At 72 hours after separator placement, at the time of separator removal
Gingival inflammation
Gingival inflammation will be assessed using the Löe Gingival Index. Scores will range from Grade 0 (healthy gingiva) to Grade 3 (severe gingivitis with spontaneous bleeding and ulceration).
Measured: At baseline, before separator placement, and immediately before separator removal, 72 hours after separator placement
Secondary outcomes (2)
Analgesic usage
Participants may take ibuprofen (400 mg) as needed for pain relief. Analgesic consumption will be recorded using a standardized patient worksheet, including the time of intake, dosage, and the arch side associated with the pain.
Measured: At 72 hours after separator placement.
Separator loss
Separator loss will be recorded clinically at the follow-up visit. A separator is considered lost if it was absent at the time of scheduled removal. Loss events are documented for each side separately.
Measured: At 72 hours after separator placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CrowdingStudies 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
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 3D-Aligners
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591454
- Sponsor's protocol ID
- UDDS-0012-2026PG/SRC1542
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because the dataset contains sensitive clinical and radiographic information, and participants did not provide consent for public sharing of individual-level data. De-identified aggregate results will be reported in the study publication.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between The Efficiency Of Elastomeric And Nickel-Titanium Separators In Tooth Separation, Pain Perception, And Gingival Inflammation - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07591454
- Acronym / sponsor ID
- UDDS-0012-2026PG/SRC1542
- Conditions
- Dental Crowding, Malocclusion, Angle Class I
- Keywords
- Orthodontic separators, Nickel-Titanium, Elastomeric, Tooth separation, Pain perception, VAS, Gingival inflammation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- 3D-AlignersIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 15 May 2026 (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.
Patients seeking fixed orthodontic treatment that requires band placement will be enrolled in this study. This trial aims to compare the efficiency of rectangular cross-section nickel-titanium separators with elastomeric separators in creating sufficient interdental space for orthodontic band placement. In addition, the impact of both separator types on pain perception and gingival health during a 3-day placement period will be evaluated. Participants will be allocated to two groups in a split-mouth design. On the experimental side, nickel-titanium separators will be used, while elastomeric separators will be used as the control on the other side. Outcomes will include separation efficacy, pain perception over time, gingival inflammation, analgesic consumption, and separator loss.
Detailed description
In fixed orthodontic therapy, placement of separators is usually the first clinical step to create interdental space between posterior teeth, particularly the first molars, in preparation for orthodontic band placement. Failure to adequately separate teeth prior to banding may result in enamel damage, distortion of the band material, soft tissue injury, and increased patient discomfort. Improper band placement without sufficient separation can also lead to excessive pressure on the periodontal ligament (PDL), a risk of alveolar bone contact, and the formation of hyalinized areas within the PDL, evoking a pain response from resident mechanoreceptors. Pain is one of the primary reasons for patient dissatisfaction and discontinuation of orthodontic treatment. Therefore, identifying an ideal orthodontic separator that can produce adequate tooth separation while minimizing pain, discomfort, and gingival inflammation is of considerable clinical importance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nickle-titanium group | Experimental | Other: Nickel-Titanium separators |
| elastomeric group | Active comparator | Other: Elastomeric separators |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Class I skeletal and dental malocclusion.
- No history of previous orthodontic treatment.
- All permanent teeth in both arches, except third molars.
- Good oral hygiene and periodontal health.
- Good interproximal tooth contacts at the site of separator placement as
Key exclusion criteria (5 listed)
- Patients presenting with restorations or carious lesions on the proximal surfaces of the first or second molars or the second premolars.
- Patients with uncontrolled gingival or periodontal inflammation.
- Patients with a history of previous orthodontic treatment.
- Patients are skeletally classified as Class II or Class III.
- Patients are currently using opioid analgesics or have chronic pain conditions requiring regular analgesic intake.
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 |
|---|---|---|
| Elastomeric separatorsapplication of the elastomeric separators before application of the orthodontic bands on the first molars | Other | elastomeric group |
| Nickel-Titanium separatorsapplication of the Nickel-Titanium separators before application of the orthodontic bands on the first molars | Other | Nickle-titanium group |
Primary outcome
Pain Perception
Time frame: At 4, 24, 48, and 72 hours after separator placement.
Pain perception will be assessed using a Visual Analogue Scale (VAS) and a standardized questionnaire. Patients will receive a pain perception worksheet containing a 100 mm horizontal VAS line for each side of the mouth. The scale will range from "no pain" to "worst pain imaginable" and will be completed during rest, biting, chewing, work/school activities, and sleep
Separation efficacy
Time frame: At 72 hours after separator placement, at the time of separator removal
Interdental separation will be measured at the time of separator removal using a feeler gauge. A separation greater than 0.16 mm will be considered sufficient for band placement, while a separation of less than 0.16 mm will be considered insufficient.
Gingival inflammation
Time frame: At baseline, before separator placement, and immediately before separator removal, 72 hours after separator placement
Gingival inflammation will be assessed using the Löe Gingival Index. Scores will range from Grade 0 (healthy gingiva) to Grade 3 (severe gingivitis with spontaneous bleeding and ulceration).
2 secondary outcomes
Analgesic usage
Time frame: At 72 hours after separator placement.
Separator loss
Time frame: At 72 hours after separator 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 15 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because the dataset contains sensitive clinical and radiographic information, and participants did not provide consent for public sharing of individual-level data. De-identified aggregate results will be reported in the study publication.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Elastomeric separators and Nickel-Titanium separators in people with Dental Crowding and Malocclusion, Angle Class I, run by 3D-Aligners.
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 7 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: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Aghiad Abdalrazzak (+963931647613, aghiad900@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Perception (time frame: At 4, 24, 48, and 72 hours after separator placement.). The study lists 3 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 15 May 2026.