Comparison of Outcome of Safe T Separators and Conventional Elastomeric Separators

ConditionMalocclusion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorKhyber College of dentistry

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

66 Participants
are divided into 1 treatment group
Group A: group A was assigned to Conventional elastomeric separators and group B to safe T separator groupOther 2 interventions

Trial outcomes

Primary outcomes

1

Amount of Pain

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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