Comparison of Outcome of Safe T Separators and Conventional Elastomeric Separators

NCT ID: NCT07119814

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-04-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: OTHER

Conventional Separators placement

Intervention Type: DEVICE

Safe T separators and conventional elastomeric separators will be placed in patients of fixed orthodontic treatment.

Safe T separator

Intervention Type: DEVICE

Safe T separators will be placed in patients of fixed orthodontic treatment

Interventions

Conventional Separators placement

Safe T separators and conventional elastomeric separators will be placed in patients of fixed orthodontic treatment.

Intervention Type: DEVICE

Safe T separator

Safe T separators will be placed in patients of fixed orthodontic treatment

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Khyber College of dentistry

OTHER

Sponsor Role: lead

Responsible Party

Haris Mustafa

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Khyber college of dentistry peshawar

Peshawar, KPK, Pakistan

Countries

Pakistan

Facility Contacts

Haris Mustafa, Bachelor in dental surgery

Role: primary

muslim.khan@kcd.edu.pk

0919221391

Other Identifiers

59/RRB/KCD

Identifier Type: -

Identifier Source: org_study_id