NCT05277506

Brief Summary

The study will be performed on human subjects undergoing orthodontic treatment to correct mild crowding with both techniques enhancing the final smile characteristics of the patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 10, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 18, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

February 18, 2022

Last Update Submit

March 3, 2022

Conditions

Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (1)

  • smile arc assessment by orthodontists

    subjective assessment of the beauty of the smile using close up photographs and questionnaires filled by orthodontists and graded scale from 0-10

    6 months follow up

Secondary Outcomes (1)

  • smile arc analysis using frontal extraoral photographs of the posed smile

    6 months follow up

Study Arms (2)

smile arc protection bonding strategy group

EXPERIMENTAL

female patients with mild crowding will recieve orthodontic brackets bonding using smile arc protection bonding strategy

Device: 18 inch slot MBT orthodontic brackets bonded using smile arc protection bonding strategy

MBT placement guide group

ACTIVE COMPARATOR

female patients with mild crowding will recieve orthodontic brackets bonding using MBT placement guide

Device: 18 inch slot MBT orthodontic brackets boned using MBT placement guide

Interventions

18 inch slot MBT orthodontic brackets bonded using smile arc protection bonding strategyDEVICE

female patients with mild crowding will recieve orthodontic brackets bonding using smile arc protection bonding strategy

smile arc protection bonding strategy group
18 inch slot MBT orthodontic brackets boned using MBT placement guideDEVICE

female patients with mild crowding will recieve orthodontic brackets bonding using MBT placement guide bonding strategy

MBT placement guide group

Eligibility Criteria

Age16 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale patients 16-30 years
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • female patients
  • no/mild/moderate crowding or spacing
  • non-extraction treatment decision with non-extraction profile
  • adults age 16-30 years
  • full permanent dentition including fully erupted 7s not necessarily 8s
  • good oral hygiene.

You may not qualify if:

  • severe crowding
  • cleft lip and palate/syndromic patients
  • bad oral hygiene
  • unerupted or partially erupted 7s
  • extracted or missing teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University, Faculty of Dentistry.

Cairo, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dentist

Study Record Dates

First Submitted

February 18, 2022

First Posted

March 14, 2022

Study Start

January 10, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

March 14, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)