An interventional study of Elastomeric separators and Nickel-Titanium separators in Dental Crowding and Malocclusion, Angle Class I, sponsored by 3D-Aligners. Not yet recruiting. Open to participants aged 16 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by 3D-Aligners · Not applicable, Interventional, and Treatment
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.
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.
88 studies on the registry are indexed under Crowding; 22 are open to participants now.
This study's planned enrollment of 30 is below the median of 36 across 74 interventional studies indexed under Crowding.
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Exclusion Criteria:
Other: Nickel-Titanium separators
Other: Elastomeric separators
application of the elastomeric separators before application of the orthodontic bands on the first molars
application of the Nickel-Titanium separators before application of the orthodontic bands on the first molars
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
Time frame: 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.
Time frame: 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).
Time frame: At baseline, before separator placement, and immediately before separator removal, 72 hours after separator placement
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.
Time frame: 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.
Time frame: At 72 hours after separator placement.
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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