Dental Crowding, Malocclusion, Angle Class I
Conditions
Keywords
Orthodontic separators, Nickel-Titanium, Elastomeric, Tooth separation, Pain perception, VAS, Gingival inflammation
Brief 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. 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.
Interventions
OTHERElastomeric separators
application of the elastomeric separators before application of the orthodontic bands on the first molars
OTHERNickel-Titanium separators
application of the Nickel-Titanium separators before application of the orthodontic bands on the first molars
Sponsors
3D-Aligners
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Perception | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic usage | At 72 hours after separator placement. | 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. |
| Separator loss | At 72 hours after separator placement. | 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. |
Contacts
CONTACTAghiad Abdalrazzak
Outcome results
None listed