Comparison of Outcome of Safe T Separators and Conventional Elastomeric Separators
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional Separators placement, Safe T separator.
- Who it may be relevant to
- Registry conditions: Malocclusion. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Conventional Separators placement
Safe T separators and conventional elastomeric separators will be placed in patients of fixed orthodontic treatment. - Device Safe T separator
Safe T separators will be placed in patients of fixed orthodontic treatment
Primary outcome measures
- Amount of Pain [Time frame: Pain will be measured over 3 days of stsrting treatment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Khyber college of dentistry peshawar — Peshawar
Identifiers
NCT: NCT07119814 · 59/RRB/KCD