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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malocclusion, Angle Class I; Dental Crowding
• Intervention / Treatment: Other: Nickel-Titanium separators; Other: Elastomeric separators

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aghiad Abdalrazzak; Phone Number: +963931647613; Email: aghiad900@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nickle-titanium group	Other: Nickel-Titanium separators; application of the Nickel-Titanium separators before application of the orthodontic bands on the first molars
Active Comparator: elastomeric group	Other: Elastomeric separators; application of the elastomeric separators before application of the orthodontic bands on the first molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At 72 hours after separator placement.

Collaborators and Investigators

• Sponsor: 3D-Aligners

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: VAS; Pain perception; Gingival inflammation; Elastomeric; Orthodontic separators; Tooth separation; Nickel-Titanium
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Infections; Gingival Diseases; Malocclusion; Behavior; Spatial Behavior; Malocclusion, Angle Class I; Gingivitis; Crowding
• Other Study ID Numbers: UDDS-0012-2026PG/SRC1542

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No