MalocclusionNCT07119814
Comparison of Outcome of Safe T Separators and Conventional Elastomeric Separators
A study testing Conventional Separators placement and Safe T separator in people with Malocclusion, run by Khyber College of dentistry at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Conventional Separators placement and Safe T separator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range (18-40) Years Male/Female Patients undergoing fixed orthodontic treatment as mentioned in operational
Who cannot join
- Patients with poor oral hygiene Patients with periodontal conditions Patients failed to provide consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Khyber college of dentistry peshawar
Peshawar, KPK, 25000
Haris Mustafa, Bachelor in dental surgery, 0919221391, muslim.khan@kcd.edu.pk
About this study
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.
- Conditions
- Malocclusion
- Being tested
- Conventional Separators placement, Safe T separator
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Separators placementDevice
Safe T separators and conventional elastomeric separators will be placed in patients of fixed orthodontic treatment.
Safe T separatorDevice
Safe T separators will be placed in patients of fixed orthodontic treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Conventional Separators placement; Device: Safe T separator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Pain
Measuring the amount of pain caused by the two modalities of treatment using visual analogue scale
Measured: Pain will be measured over 3 days of stsrting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber College of dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haris Mustafa, Khyber College of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119814
- Sponsor's protocol ID
- 59/RRB/KCD
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome of Safe T Separators and Conventional Elastomeric Separators
- ClinicalTrials.gov ID
- NCT07119814
- Acronym / sponsor ID
- 59/RRB/KCD
- Conditions
- Malocclusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Khyber College of dentistryUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group A was assigned to Conventional elastomeric separators and group B to safe T separator group | Other | Device: Conventional Separators placement, Device: Safe T separatorPlacement of conventional elastomeric separators and safe T separators intraorally in patients coming for fixed orthodontic treatment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age range (18-40) Years Male/Female Patients undergoing fixed orthodontic treatment as mentioned in operational
Key exclusion criteria (1 listed)
- Patients with poor oral hygiene Patients with periodontal conditions Patients failed to provide consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Separators placementSafe T separators and conventional elastomeric separators will be placed in patients of fixed orthodontic treatment. | Device | group A was assigned to Conventional elastomeric separators and group B to safe T separator group |
| Safe T separatorSafe T separators will be placed in patients of fixed orthodontic treatment | Device | group A was assigned to Conventional elastomeric separators and group B to safe T separator group |
Primary outcome
Amount of Pain
Time frame: Pain will be measured over 3 days of stsrting treatment
Measuring the amount of pain caused by the two modalities of treatment using visual analogue scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Separators placement and Safe T separator in people with Malocclusion, run by Khyber College of dentistry at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Pain (time frame: Pain will be measured over 3 days of stsrting treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.