Treatment Outcome of Elastomeric and Nickel-Titanium Separators in Tooth Separation

NCT07591454 | Not Yet Recruiting

• 1 other identifier: UDDS-0012-2026PG/SRC1542
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Crowding; Malocclusion, Angle Class I

Keywords

Orthodontic separators; Nickel-Titanium; Elastomeric; Tooth separation; Pain perception; VAS; Gingival inflammation

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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).

  At baseline, before separator placement, and immediately before separator removal, 72 hours after separator placement

Secondary Outcomes (2)

• Analgesic usage

  At 72 hours after separator placement.

• Separator loss

  At 72 hours after separator placement.

Study Arms (2)

Nickle-titanium group

EXPERIMENTAL

Other: Nickel-Titanium separators

elastomeric group

ACTIVE COMPARATOR

Other: Elastomeric separators

Interventions

Elastomeric separators OTHER

application of the elastomeric separators before application of the orthodontic bands on the first molars

elastomeric group

Nickel-Titanium separators OTHER

application of the Nickel-Titanium separators before application of the orthodontic bands on the first molars

Nickle-titanium group

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 3D-Aligners: lead

MeSH Terms

Conditions

Crowding; Malocclusion, Angle Class I; Gingivitis

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior; Malocclusion; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Central Study Contacts

Aghiad Abdalrazzak

CONTACT

+963931647613; aghiad900@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share