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Not yet recruitingNCT07119814Updated Aug 13, 2025

Comparison of Outcome of Safe T Separators and Conventional Elastomeric Separators

An interventional study of Conventional Separators placement and Safe T separator in Malocclusion, sponsored by Khyber College of dentistry. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-13.

Sponsored by Khyber College of dentistry · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.

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Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Malocclusion

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03

In context

Malocclusion

323 studies on the registry are indexed under Malocclusion; 84 are open to participants now.

This study's planned enrollment of 66 is above the median of 37 across 242 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Khyber College of dentistry is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with poor oral hygiene Patients with periodontal conditions Patients failed to provide consent form
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Other
    group A was assigned to Conventional elastomeric separators and group B to safe T separator group

    Placement of conventional elastomeric separators and safe T separators intraorally in patients coming for fixed orthodontic treatment.

    Device: Conventional Separators placement · Device: Safe T separator

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

06

What researchers measure

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2025; primary completion for Mar 2026, 3 months later.

Of 153 non-industry interventional studies with no phase under Malocclusion, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's planned 3 months is below that.

Counting every sponsor, half of 163 studies reached it within 19 months; a quarter within 10 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2025
First posted
Aug 13, 2025
StartEst.
Dec 1, 2025
Primary completionEst.
Mar 31, 2026
CompletionEst.
Apr 15, 2026
Last update
Aug 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07119814
Lead sponsor
Khyber College of dentistry
Responsible party
Haris Mustafa (Dr., Khyber College of dentistry) — Principal investigator
First posted
Aug 13, 2025
Start date
Dec 1, 2025 (estimated)
Primary completion
Mar 31, 2026 (estimated)
Completion
Apr 15, 2026 (estimated)
Last update
Aug 13, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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