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
Qualifiers
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
Treatments tested in this trial
- Elastomeric separators
- Nickel-Titanium separators
Treatment groups
30 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov