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NCT Number: NCT07119814

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khyber college of dentistry peshawar

Peshawar, KPK, 25000, Pakistan

Location contact

Haris Mustafa, Bachelor in dental surgery

CONTACT

[email protected]

0919221391

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Separators placement

Device

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

Safe T separator

Device

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

Primary outcomes

  1. Amount of Pain

    Time frame: Pain will be measured over 3 days of stsrting treatment

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

Sponsors and collaborators

Lead sponsor

Khyber College of dentistry

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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