Smile Arc Assessment in Orthodontic Patients Following Smile Arc Protection VS MBT Placement Guide Bonding Strategies

March 3, 2022 updated by: Noura Mohamed Hamza Hassan Saleh, Cairo University

Smile Arc Assessment in Orthodontic Patients Following Smile Arc Protection Versus MBT Placement Guide Bonding Strategies: A Randomized Clinical Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study concisits of two groups, the intervention group entails performing bonding of orthodontic brackets following smile arc protection bonding strategy while the control group entails performing bonding using the MBT placement guide and comparing the final smile outcomes after reaching steel archwires for both groups using customized questionnaires for orthodontists and laypersons.

Study Type

Interventional

Enrollment (Anticipated)

22

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

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

16 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: smile arc protection bonding strategy group
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
female patients with mild crowding will recieve orthodontic brackets bonding using smile arc protection bonding strategy
Active Comparator: MBT placement guide group
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
female patients with mild crowding will recieve orthodontic brackets bonding using MBT placement guide bonding strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
smile arc assessment by orthodontists
Time Frame: 6 months follow up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
smile arc analysis using frontal extraoral photographs of the posed smile
Time Frame: 6 months follow up
analysis in millimeters for anthropometric measurements
6 months follow up

Collaborators and Investigators

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

Sponsor

Cairo University

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)

January 10, 2022

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

March 3, 2022

First Posted (Actual)

March 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ORTH 3-3-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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