NCT07712055

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
Last Updated

July 17, 2026

Status Verified

June 1, 2026

Enrollment Period

1.8 years

First QC Date

July 12, 2026

Last Update Submit

July 15, 2026

Conditions

Dental CrowdingSmile Arc CorrectionMaxillary Crowded Teeth

Keywords

dental crowdingSmile arc protection

Outcome Measures

Primary Outcomes (2)

  • Initial maxillary alignment and smile arc development

    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

    Baseline to 6 months

Study Arms (2)

PITTS 21

EXPERIMENTAL

Pitts 21 is a self ligating bracket system

Device: Pitts 21 bracket systemDevice: MBT bracket system

MBT

ACTIVE COMPARATOR

MBT is a conventional bracket system

Device: Pitts 21 bracket systemDevice: MBT bracket system

Interventions

MBT bracket systemDEVICE

This is a conventional backet system in orthododntics

MBTPITTS 21
Pitts 21 bracket systemDEVICE

This is a self ligating orthodontic bracket system

MBTPITTS 21

Eligibility Criteria

Age13 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mangalore

Mangalore, Karnataka, 575001, India

Location

MeSH Terms

Conditions

Crowding

Condition Hierarchy (Ancestors)

Spatial BehaviorBehavior

Study Officials

  • MAHEN NAIK, Post graduate

    Srinivas Institute of Dental Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mahen Naik

Study Record Dates

First Submitted

July 12, 2026

First Posted

July 17, 2026

Study Start

March 2, 2024

Primary Completion

December 20, 2025

Study Completion

January 15, 2026

Last Updated

July 17, 2026

Record last verified: 2026-06

Locations

IN(1)