NCT07752290

Brief Summary

Adhesive PreCoated (APC) flash-free brackets have been recently introduced, with no need of flash removal step. Evaluation of APC and conventional brackets and their effects on enamel demineralization and periodontal health.

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 Jul 2024

Shorter than P25 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

July 20, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

July 13, 2026

Last Update Submit

August 3, 2026

Conditions

Enamel Demineralization

Keywords

Periodontal IndexBleeding on probingLaser fluorescenceOral Hygiene

Outcome Measures

Primary Outcomes (1)

  • comparative assessment of Adhesive PreCoated (APC) flash-free and conventional brackets and their effects on enamel demineralization and periodontal health

    To evaluate the difference of APC and conventional brackets, and their effects on enamel demineralization and periodontal health using diagnodont pen using numerical value on a 0 to 99 scale. 0 - 12: Healthy tooth structure; no or minimal fluorescence.13 - 24: Enamel caries, 25 - 99: Dentin caries

    6 months

Study Arms (2)

APC brackets (3M Oral Care St.Paul, MN, USA)

EXPERIMENTAL

PreCoated brackets (APC)

Other: Group A

Conventional Brackets (UK Ltd)

ACTIVE COMPARATOR

Non-coated brackets

Other: Group B

Interventions

Group AOTHER

Adhesive PreCoated (APC) Flash-free brackets

APC brackets (3M Oral Care St.Paul, MN, USA)
Group BOTHER

Conventional brackets (Ortho Care UK Ltd)

Conventional Brackets (UK Ltd)

Eligibility Criteria

Age12 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Good periodontal health with no history of systemic problems
  • Mild to moderate crowding
  • Class I and Class II malocclusions
  • Non extraction treatment plan
  • Permanent dentition and no visible demineralization of buccal/labial surfaces of teeth
  • Absence of rotated teeth
  • No past history of orthodontic treatment

You may not qualify if:

  • Severe Class III/Class II malocclusions
  • Primary/mixed dentition
  • Patients not willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FUI

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Study Officials

  • Shoaib Rahim, FCPS

    FUCD & H

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 13, 2026

First Posted

August 7, 2026

Study Start

July 20, 2024

Primary Completion

November 10, 2024

Study Completion

December 10, 2024

Last Updated

August 7, 2026

Record last verified: 2026-08

Locations

PA(1)