NCT07119814

Comparison of Outcome of Safe T Separators and Conventional Elastomeric Separators

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Khyber College of dentistry · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

All participants in this study will be provided with information concerning the study's objectives, and benefits associated with participation. Participants will be informed that their involvement in this study presents no potential risks associated with their participation. Written consent will be obtained with appropriate information provided. Demographic data like age, BMI, gender, residence, socio economic status, occupation status, and literacy status will be documented. Patients undergoing fixed orthodontic treatment will be allocated in two groups equally by using the blocked randomization technique. Patients in Group A will undergo safe-T separators i.e initial thickness of Safe-T separators will be 1mm, Patients in Group B will undergo conventional elastomeric separators i.e thickness of elastomeric separators will be 1.2 mm. Separators will be positioned on either side of lower arch, each type of separator will be in sites, resulting in a sites within the lower arch. A separator placement tool will be utilised to position the separators. The comprehensive assessment will be carried out under the supervision of a consultant possessing at least five years of post-fellowship experience. Patient data will be recorded using a predefined structured proforma.

Conditions

• Malocclusion

Interventions

Type	Name	Description
DEVICE	Conventional Separators placement	Safe T separators and conventional elastomeric separators will be placed in patients of fixed orthodontic treatment.
DEVICE	Safe T separator	Safe T separators will be placed in patients of fixed orthodontic treatment

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-03-31
• Completion: 2026-04-15
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: Pakistan