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Comparison of Outcome of Safe T Separators and Conventional Elastomeric Separators

Comparison of Outcome of Safe T Separators and Conventional Elastomeric Separators

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07119814
Enrollment
66
Registered
2025-08-13
Start date
2025-12-01
Completion date
2026-04-15
Last updated
2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion

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.

Interventions

DEVICEConventional Separators placement

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

DEVICESafe T separator

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

Sponsors

Khyber College of dentistry
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Amount of PainPain will be measured over 3 days of stsrting treatmentMeasuring the amount of pain caused by the two modalities of treatment using visual analogue scale

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026