Malocclusion of Anterior TeethNCT07014332
Comparison of Alignment Efficiency of Steel Vs Elastomeric Ligatures In Lower Anterior Teeth
A study testing Steel ligature and Elastomeric ligature in people with Malocclusion of Anterior Teeth, run by Khyber College of dentistry at 1 site in Pakistan.
Trial summary
To compare the treatment time required by elastomeric ligatures and steel ligatures, in days, to achieve complete alignment of the lower anterior teeth. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Malocclusion of Anterior Teeth
- What is being tested?
- Steel ligature and Elastomeric ligature
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 sitePakistan
- Study dates
- 19 Sep 2024to 10 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients coming for fixed orthodontic treatment requiring premolar extraction in mandibular arch.
- Age 12-18 years.
- No adjunct therapeutic intervention involving functional or orthopaedic appliances.
- Little's Irregularity index score of 7-9mm.
Who cannot join
- Patients with systemic conditions and taking medications affecting tooth movement.
- Lower anterior teeth that are missing, impacted or unerupted, or have fractured crown, restorations, Enamel Defects, Caries.
- Poor periodontal health
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Khyber College of Dentistry
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
Official title: Comparison of Alignment Efficiency of Steel Vs Elastomeric Ligatures In Lower Anterior Teeth: A Randomized Clinical Trial
To compare the treatment time required by elastomeric ligatures and steel ligatures, in days, to achieve complete alignment of the lower anterior teeth.
Read the detailed description
Treatment time required to achieve alignment by two ligation methods will help us in future to choose a better method. The two methods study are elastomeric ligature and steel ligature.
- Conditions
- Malocclusion of Anterior Teeth
- Being tested
- Steel ligature, Elastomeric ligature
- Keywords
- Orthodontic treatment, Ligature type, Steel ligature, Elastomeric ligature, Alignment time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steel ligatureDevice
Steel ligatures that are used to ligate wire with bracket
Elastomeric ligatureDevice
Elastomeric ligature that is used to ligate wire to bracket
| Study group | Role | What they receive |
|---|---|---|
| Group A received steel ligature and group B elastomeric ligature | Other | Not described Receives: Device: Steel ligature; Device: Elastomeric ligature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alignment time to reach little irregularity index of zero
Measured: From recruitment to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start19 Sep 2024
- Primary completion10 May 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion of Anterior TeethStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber College of dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aatikah Javaid, Khyber College of dentistry
- Investigators
- Ahsan Mehmood Shah, Fellowship, Study director, Khyber College of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014332
- Sponsor's protocol ID
- 45/ADR/KCD
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Alignment Efficiency of Steel Vs Elastomeric Ligatures In Lower Anterior Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07014332
- Acronym / sponsor ID
- 45/ADR/KCD
- Conditions
- Malocclusion of Anterior Teeth
- Keywords
- Orthodontic treatment, Ligature type, Steel ligature, Elastomeric ligature, Alignment time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Khyber College of dentistryUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 11 Jun 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.
To compare the treatment time required by elastomeric ligatures and steel ligatures, in days, to achieve complete alignment of the lower anterior teeth.
Detailed description
Treatment time required to achieve alignment by two ligation methods will help us in future to choose a better method. The two methods study are elastomeric ligature and steel ligature.
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 received steel ligature and group B elastomeric ligature | Other | Device: Steel ligature, Device: Elastomeric ligature |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients coming for fixed orthodontic treatment requiring premolar extraction in mandibular arch.
- Age 12-18 years.
- No adjunct therapeutic intervention involving functional or orthopaedic appliances.
- Little's Irregularity index score of 7-9mm.
Key exclusion criteria (3 listed)
- Patients with systemic conditions and taking medications affecting tooth movement.
- Lower anterior teeth that are missing, impacted or unerupted, or have fractured crown, restorations, Enamel Defects, Caries.
- Poor periodontal health
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 |
|---|---|---|
| Steel ligatureSteel ligatures that are used to ligate wire with bracket | Device | Group A received steel ligature and group B elastomeric ligature |
| Elastomeric ligatureElastomeric ligature that is used to ligate wire to bracket | Device | Group A received steel ligature and group B elastomeric ligature |
Primary outcome
Alignment time to reach little irregularity index of zero
Time frame: From recruitment to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Malocclusion of Anterior Teeth
Not yet recruiting
Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth
Enamel Hypomineralization, Dental
Not yet recruiting
Impact of Various Acceleration Techniques on En-masse Retraction of Maxillary Anterior Teeth
Accelerate Tooth Movement
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
Fluoride Varnishes, Molar Incisor Hypomineralisation
Recruiting
Clinical Evaluation of Bioflx Crowns in Restoring Primary Anterior Teeth
Clinical, Primary Teeth
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. This study is not recruiting at the moment.
Ahsan Mehmood Shah, Fellowship study director
Khyber College of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steel ligature and Elastomeric ligature in people with Malocclusion of Anterior Teeth, 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 11 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alignment time to reach little irregularity index of zero (time frame: From recruitment to 8 months). 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 11 Jun 2025.