Comparison of Outcome of Safe T Separators and Conventional Elastomeric Separators

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.

NCT Number	NCT07119814
Lead Sponsor	Khyber College of dentistry
Conditions	Malocclusion
Enrollment	66 participants
Start Date	2025-12-01
Primary Completion	2026-03-31 (estimated)
Study Completion	2026-04-15 (estimated)
Updated on ClinicalTrials.gov	2025-08-13