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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Separators placement | Device | Safe T separators and conventional elastomeric separators will be placed in patients of fixed orthodontic treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Khyber college of dentistry peshawar | Peshawar | KPK | 25000 | Pakistan |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Safe T separator | Device | Safe T separators will be placed in patients of fixed orthodontic treatment |
|