Comparison of Outcome of Safe T Separators and Conventional Elastomeric Separators

NCT07119814 | Not Yet Recruiting

• 1 other identifier: 59/RRB/KCD
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Amount of Pain

  Measuring the amount of pain caused by the two modalities of treatment using visual analogue scale

  Pain will be measured over 3 days of stsrting treatment

Study Arms (1)

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

OTHER

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

Device: Conventional Separators placement; Device: Safe T separator

Interventions

Conventional Separators placement DEVICE

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

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

Safe T separator DEVICE

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

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Khyber College of dentistry: lead

Study Sites (1)

Khyber college of dentistry peshawar

Peshawar, KPK, 25000, Pakistan

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: December 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 15, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)