Comparison of Outcome of Safe T Separators and Conventional Elastomeric Separators

Khyber College of dentistry

Status: Not yet enrolling

Conditions: Malocclusion

Treatments: Device: Safe T separator; Device: Conventional Separators placement

Study type: Interventional

Funder types: Other

Identifiers

NCT07119814

59/RRB/KCD

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age range (18-40) Years Male/Female Patients undergoing fixed orthodontic treatment as mentioned in operational

Exclusion criteria

• Patients with poor oral hygiene Patients with periodontal conditions Patients failed to provide consent form

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

group A was assigned to Conventional elastomeric separators and group B to safe T separator group

Other group

Description:

Placement of conventional elastomeric separators and safe T separators intraorally in patients coming for fixed orthodontic treatment.

Treatment:

Device: Conventional Separators placement

Device: Safe T separator