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NOT YET RECRUITING
NCT07119814
NA

Comparison of Outcome of Safe T Separators and Conventional Elastomeric Separators

Sponsor: Khyber College of dentistry

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2025-12-01

Completion Date

2026-04-15

Last Updated

2025-08-13

Healthy Volunteers

Yes

Conditions

Interventions

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

Locations (1)

Khyber college of dentistry peshawar

Peshawar, KPK, Pakistan