Treatment Outcome of Elastomeric and Nickel-Titanium Separators in Tooth Separation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-25
Sponsor3D-Aligners
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Elastomeric separators
Other interventionapplication of the elastomeric separators before application of the orthodontic bands on the first molars
Nickel-Titanium separators
Other interventionapplication of the Nickel-Titanium separators before application of the orthodontic bands on the first molars
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Nickle-titanium groupExperimental treatment 1 intervention
Group B: elastomeric groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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 removal3
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 placementSecondary outcomes
1
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.2
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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