PainNCT06895083
Comparison of Self-ligating and Conventional MBT Brackets Regarding Alignment Efficiency and Pain Perception
A study testing self ligating brackets in people with Pain, run by Shoaib Rahim at 1 site in Pakistan.
Trial summary
The rate of Orthodontic tooth movement affects the efficacy and time duration of the treatment. One of the key factors, during the initial alignment phase, is the amount of the force that the arch-wire applies to the dentition. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- self ligating brackets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Sep 2023to 10 Mar 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with Non extraction orthodontic treatment plan
- Crowding of 3 to 6 mm according to Little's irregularity index
- Both male and female patients
- 14-20 years of age.
- All permanent teeth present up to first permanent molar
Who cannot join
- Poor oral hygiene
- Systemic disease
- Patients with periodontally compromised teeth
- Patient requiring Orthognathic surgery to correct skeletal discrepancies
- Patients taking medications, like NSAIDs or other anti-inflammatory drugs
- Cleft lip or palate
- Hypodontia, or Hyperdontia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Self-ligating and Conventional MBT Brackets Regarding Alignment Efficiency and Pain Perception: A Randomized Clinical Trial
The rate of Orthodontic tooth movement affects the efficacy and time duration of the treatment. One of the key factors, during the initial alignment phase, is the amount of the force that the arch-wire applies to the dentition. The amount of the applied force and the rate of tooth movement are directly proportional to the frictional resistance between the arch wire and bracket. The quality and degree of resistance is related to the physical characteristics of the arch wire, bracket material, arch wire dimensions, and the type of arch wire ligation. The estimated rate of tooth movement is about 0.35 to 2.04 mm per month, which is influenced by various factors and variables including the biological response of the individual to orthodontic forces, the complexity of the case, treatment mechanics and patient compliance throughout the course of treatment .
Read the detailed description
To compare the alignment efficiency and pain experience of Mico-one self-ligating and conventional ligating MBT pre-adjusted brackets in the initial alignment stage of patients undergoing orthodontic treatment.CONVENTIONAL MBT BRACKETS: In conventional brackets elastic ligatures or metal ties are used to ligate the wire in the bracket slot. 2. SELF-LIGATING BRACKETS: Self-ligating brackets like conventional braces are placed relatively the same way.
The exception is that self-ligating braces don't use elastics, or metal ties. Instead it has special clips or brackets with a spring-loaded door. The brackets while maintaing pressure on the archwire, help move the teeth along it at a steady pace .[9] 3 .ALIGNMENT EFFICIENCY Movement of the teeth measured at four months interval. Scoring method involves measuring the linear distance between anatomical contact points between maxillary and mandibular incisors from adjacent tooth anatomical points. (Little's irregularity index)
4.PAIN Unpleasant sensory and emotional experience associated with tooth movement will be measured as a mean using the VAS at 4 hours, 24 hours, day 3, day 7, 1 st Month, 2 nd Month, 3 rd Month and 4 th Month.
- Conditions
- Pain
- Being tested
- self ligating brackets
- Keywords
- alignment efficiency, pain perception
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self ligating bracketsOther
selfligating are new brackets
| Study group | Role | What they receive |
|---|---|---|
| conventional | No intervention | Participants in this arm will conventional brackets |
| Experimental | Experimental | Participants in this arm will self ligating brackets Receives: Other: self ligating brackets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alignment efficiency
amount of tooth movement in millimeters
Measured: 4 months
Secondary outcomes (1)
Pain with tooth movement
pain perception using visual analogue scale with Zero equivalent to no pain and 10 indicates the worst possible pain
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start30 Sep 2023
- Primary completion10 Feb 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-blind, randomized parallel-arm study with two arms. Participants will be randomly assigned to either receive self ligating brackets or conventional brackets regarding Alignment efficiency and pain experience.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shoaib Rahim
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation University Islamabad
- Responsible party
- Sponsor-investigator, Shoaib Rahim, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895083
- Sponsor's protocol ID
- FF/FUMC/215-329Phy/23
- Status last verified
- Jun 2026
- First submitted
- 19 Mar 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To compare the alignment efficiency and pain experience of Mico-one self-ligating and conventional ligating MBT pre-adjusted brackets in the initial alignment stage of patients undergoing orthodontic treatment.
Publications
1. Wagner D, Lévy-Benichou H, Lefebvre F, Bolender Y. [Are self-ligating brackets more efficient than conventional brackets ? A meta-analysis of randomized controlled and split-mouth trials]. L' Orthodontie Francaise. 2020 Dec;91(4):303-321 2. Tantidhnazet S, Leehathorn P, Rattanasumawong S, Santiwong P. Comparison of self-ligating bracket and conventional bracket in orthodontic treatment: A systematic review. M Dent J 2018; 38: 213-228 3. Dehbi H, Azaroual MF, Zaoui F, Halimi A, Benyahia H. Therapeutic efficacy of self-ligating brackets: A systematic review. Int Orthod. 2017 Sep;15(3):297-311. 4. Jahanbin A, Hasanzadeh N, Khaki S, Shafaee H. Comparison of self-ligating Damon3 and conventional MBT brackets regarding alignment efficiency and pain experience: A randomized clinical trial. J Dent Res Dent Clin Dent Prospects. 2019 Fall;13(4):281-288. 5. Galvão MCS, Sato JR, Coelho EC. Dahlberg formula - a novel approach for its evaluation. Dental Press J Orthod. 2012;17(1):115-24.)
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Self-ligating and Conventional MBT Brackets Regarding Alignment Efficiency and Pain Perception: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06895083
- Acronym / sponsor ID
- FF/FUMC/215-329Phy/23
- Conditions
- Pain
- Keywords
- alignment efficiency, pain perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shoaib RahimUniversity, hospital or other
- Collaborators
- Foundation University Islamabad
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 26 Mar 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.
The rate of Orthodontic tooth movement affects the efficacy and time duration of the treatment. One of the key factors, during the initial alignment phase, is the amount of the force that the arch-wire applies to the dentition. The amount of the applied force and the rate of tooth movement are directly proportional to the frictional resistance between the arch wire and bracket. The quality and degree of resistance is related to the physical characteristics of the arch wire, bracket material, arch wire dimensions, and the type of arch wire ligation. The estimated rate of tooth movement is about 0.35 to 2.04 mm per month, which is influenced by various factors and variables including the biological response of the individual to orthodontic forces, the complexity of the case, treatment mechanics and patient compliance throughout the course of treatment .
Detailed description
To compare the alignment efficiency and pain experience of Mico-one self-ligating and conventional ligating MBT pre-adjusted brackets in the initial alignment stage of patients undergoing orthodontic treatment.CONVENTIONAL MBT BRACKETS: In conventional brackets elastic ligatures or metal ties are used to ligate the wire in the bracket slot. 2. SELF-LIGATING BRACKETS: Self-ligating brackets like conventional braces are placed relatively the same way.
The exception is that self-ligating braces don't use elastics, or metal ties. Instead it has special clips or brackets with a spring-loaded door. The brackets while maintaing pressure on the archwire, help move the teeth along it at a steady pace .[9] 3 .ALIGNMENT EFFICIENCY Movement of the teeth measured at four months interval. Scoring method involves measuring the linear distance between anatomical contact points between maxillary and mandibular incisors from adjacent tooth anatomical points. (Little's irregularity index)
4.PAIN Unpleasant sensory and emotional experience associated with tooth movement will be measured as a mean using the VAS at 4 hours, 24 hours, day 3, day 7, 1 st Month, 2 nd Month, 3 rd Month and 4 th Month.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-blind, randomized parallel-arm study with two arms. Participants will be randomly assigned to either receive self ligating brackets or conventional brackets regarding Alignment efficiency and pain experience.
| Arm | Type | Receives |
|---|---|---|
| conventional | No intervention | –Participants in this arm will conventional brackets |
| Experimental | Experimental | Other: self ligating bracketsParticipants in this arm will self ligating brackets |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with Non extraction orthodontic treatment plan
- Crowding of 3 to 6 mm according to Little's irregularity index
- Both male and female patients
- 14-20 years of age.
- All permanent teeth present up to first permanent molar
Key exclusion criteria (7 listed)
- Poor oral hygiene
- Systemic disease
- Patients with periodontally compromised teeth
- Patient requiring Orthognathic surgery to correct skeletal discrepancies
- Patients taking medications, like NSAIDs or other anti-inflammatory drugs
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 |
|---|---|---|
| self ligating bracketsselfligating are new brackets | Other | Experimental |
Primary outcome
Alignment efficiency
Time frame: 4 months
amount of tooth movement in millimeters
1 secondary outcome
Pain with tooth movement
Time frame: Four 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 1 Jul 2026.
- Results publication1. Wagner D, Lévy-Benichou H, Lefebvre F, Bolender Y. [Are self-ligating brackets more efficient than conventional brackets ? A meta-analysis of randomized controlled and split-mouth trials]. L' Orthodontie Francaise. 2020 Dec;91(4):303-321 2. Tantidhnazet S, Leehathorn P, Rattanasumawong S, Santiwong P. Comparison of self-ligating bracket and conventional bracket in orthodontic treatment: A systematic review. M Dent J 2018; 38: 213-228 3. Dehbi H, Azaroual MF, Zaoui F, Halimi A, Benyahia H. Therapeutic efficacy of self-ligating brackets: A systematic review. Int Orthod. 2017 Sep;15(3):297-311. 4. Jahanbin A, Hasanzadeh N, Khaki S, Shafaee H. Comparison of self-ligating Damon3 and conventional MBT brackets regarding alignment efficiency and pain experience: A randomized clinical trial. J Dent Res Dent Clin Dent Prospects. 2019 Fall;13(4):281-288. 5. Galvão MCS, Sato JR, Coelho EC. Dahlberg formula - a novel approach for its evaluation. Dental Press J Orthod. 2012;17(1):115-24.)
- Individual participant dataSharing planned: No. To compare the alignment efficiency and pain experience of Mico-one self-ligating and conventional ligating MBT pre-adjusted brackets in the initial alignment stage of patients undergoing orthodontic treatment.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self ligating brackets in people with Pain, run by Shoaib Rahim 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 5 inclusion and 7 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 1 Jul 2026. 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 efficiency (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06895083, which also lists 1 linked publication.
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 1 Jul 2026.