Dental CrowdingNCT07712055
A Study to Evaluate the Relationship Between Two Bracket System and Their Contribution to Initial Alignment of Maxillary Anteriors - De Crowding, Smile Arc Protection.
A study testing Pitts 21 bracket system and MBT bracket system in people with Dental Crowding and Smile Arc Correction, run by Srinivas College of Dental Sciences at 1 site in India.
Trial summary
The goal of this clinical trial is to compare the two orthodontic bracket systems namely MBT and the Pitts21 for maxillary anterior decrowding, initial alignment as well as the smile arc correction in 6 month period. Read more about this study
- Who is it for?
- Ages 13 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Crowding, Smile Arc Correction, Maxillary Crowded Teeth
- What is being tested?
- Pitts 21 bracket system and MBT bracket system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 2 Mar 2024to 15 Jan 2026
- 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 13 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- mild to moderate maxillary anterior irregularity
- indication for non-extraction orthodontic treatment
- presence of all permanent teeth up to the first molars
- healthy periodontal status and good oral hygiene; and
- age between 13 and 40 year
Who cannot join
- craniofacial anomalies or cleft lip/palate
- hypodontia or hyperdontia
- systemic diseases or bone disorders affecting tooth movement;
- tooth size anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Efficacy of Self Ligating Pitts21® and Conventional Preadjusted Edge Wise Technique (Mclaughlin Bennett Trevisi) In Alignment and Smile Arc Correction: A Randomized Clinical Trial
The goal of this clinical trial is to compare the two orthodontic bracket systems namely MBT and the Pitts21 for maxillary anterior decrowding, initial alignment as well as the smile arc correction in 6 month period.
Read the detailed description
This randomized clinical trial is done among participants who reported with mild to moderate maxillary anterior crowding. The initial alignment of the dental arch and development of smile arc was evaluated.
- Being tested
- Pitts 21 bracket system, MBT bracket system
- Keywords
- dental crowding, Smile arc protection
- Medical subject headings
- Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitts 21 bracket systemDevice
This is a self ligating orthodontic bracket system
MBT bracket systemDevice
This is a conventional backet system in orthododntics
| Study group | Role | What they receive |
|---|---|---|
| PITTS 21 | Experimental | Pitts 21 is a self ligating bracket system Receives: Device: Pitts 21 bracket system; Device: MBT bracket system |
| MBT | Active comparator | MBT is a conventional bracket system Receives: Device: Pitts 21 bracket system; Device: MBT bracket system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial maxillary alignment and smile arc development
Measured: Baseline to 6 months
Dental alignment
It was assessed on maxillary alginate impression at baseline, 2 months, 4 months and 6 months. Casts were poured and a digital caliper was used to mmeasure
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start2 Mar 2024
- Primary completion20 Dec 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CrowdingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Srinivas College of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahen Naik, Srinivas College of Dental Sciences
- Investigators
- MAHEN NAIK, Post graduate, Principal investigator, Srinivas Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712055
- Sponsor's protocol ID
- SIDSEC/PG/05/2024
- Status last verified
- Jun 2026
- First submitted
- 12 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Efficacy of Self Ligating Pitts21® and Conventional Preadjusted Edge Wise Technique (Mclaughlin Bennett Trevisi) In Alignment and Smile Arc Correction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07712055
- Acronym / sponsor ID
- SIDSEC/PG/05/2024
- Keywords
- dental crowding, Smile arc protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Srinivas College of Dental SciencesUniversity, hospital or other
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 17 Jul 2026 (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 goal of this clinical trial is to compare the two orthodontic bracket systems namely MBT and the Pitts21 for maxillary anterior decrowding, initial alignment as well as the smile arc correction in 6 month period.
Detailed description
This randomized clinical trial is done among participants who reported with mild to moderate maxillary anterior crowding. The initial alignment of the dental arch and development of smile arc was evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PITTS 21 | Experimental | Device: Pitts 21 bracket system, Device: MBT bracket systemPitts 21 is a self ligating bracket system |
| MBT | Active comparator | Device: Pitts 21 bracket system, Device: MBT bracket systemMBT is a conventional bracket system |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- mild to moderate maxillary anterior irregularity
- indication for non-extraction orthodontic treatment
- presence of all permanent teeth up to the first molars
- healthy periodontal status and good oral hygiene; and
- age between 13 and 40 year
Key exclusion criteria (4 listed)
- craniofacial anomalies or cleft lip/palate
- hypodontia or hyperdontia
- systemic diseases or bone disorders affecting tooth movement;
- tooth size anomalies
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 |
|---|---|---|
| Pitts 21 bracket systemThis is a self ligating orthodontic bracket system | Device | MBT, PITTS 21 |
| MBT bracket systemThis is a conventional backet system in orthododntics | Device | MBT, PITTS 21 |
Primary outcome
Initial maxillary alignment and smile arc development
Time frame: Baseline to 6 months
Dental alignment
Time frame: Baseline to 6 months
It was assessed on maxillary alginate impression at baseline, 2 months, 4 months and 6 months. Casts were poured and a digital caliper was used to mmeasure
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 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Crowding
Not yet recruiting
Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Mild-to-Moderate Mandibular Anterior Crowding
Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth
RecruitingObservational study
Exploration of the Utility of Dental-dedicated MRI for Dentistry
Dental Crowding, Dental Occlusion, Traumatic
Enrolling by invitation
Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment
Crowding of Anterior Mandibular Teeth
Not yet recruiting
Effect of Different Adhesive Systems on White Spot Lesions During Fixed Orthodontic Treatment
Malaligned Teeth, Crowding of 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.
MAHEN NAIK, Post graduate principal investigator
Srinivas Institute of Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pitts 21 bracket system and MBT bracket system in people with Dental Crowding and Smile Arc Correction, run by Srinivas College of Dental Sciences at 1 site in India.
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 4 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 17 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 India. 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?
Initial maxillary alignment and smile arc development (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. 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 17 Jul 2026.