A Study to Evaluate the Relationship Between Two Bracket System and Their Contribution to Initial Alignment of Maxillary Anteriors - De Crowding, Smile Arc Protection.

July 15, 2026 updated by: Mahen Naik, Srinivas College of Dental Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Mangalore, Karnataka, India, 575001
        • Mangalore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • craniofacial anomalies or cleft lip/palate
  • hypodontia or hyperdontia
  • systemic diseases or bone disorders affecting tooth movement;
  • tooth size anomalies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PITTS 21
Pitts 21 is a self ligating bracket system
Device: Pitts 21 bracket system
This is a self ligating orthodontic bracket system
Device: MBT bracket system
This is a conventional backet system in orthododntics
Active Comparator: MBT
MBT is a conventional bracket system
Device: Pitts 21 bracket system
This is a self ligating orthodontic bracket system
Device: MBT bracket system
This is a conventional backet system in orthododntics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial maxillary alignment and smile arc development
Time Frame: Baseline to 6 months
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
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Srinivas College of Dental Sciences

Investigators

  • Principal Investigator: MAHEN NAIK, Post graduate, Srinivas Institute of Dental Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2024

Primary Completion (Actual)

December 20, 2025

Study Completion (Actual)

January 15, 2026

Study Registration Dates

First Submitted

July 12, 2026

First Submitted That Met QC Criteria

July 15, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIDSEC/PG/05/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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