Oral Health-Related Quality of Life Between Two Different Types of Orthodontic Appliances

May 2, 2024 updated by: Damascus University

The Impact of A Modified Aligner Appliance With NiTi Springs and Conventional Fixed Appliances on Oral Health-related Quality of Life in Patients With Mild Crowding

Patients who have mild crowding from the Orthodontic Department at University of Damascus Dental School will be treated in this trial. The effects of modified aligner appliance with NiTi springs on oral health-related quality of life (OHRQoL) compared with conventional fixed appliances using the OHIP-14 questionnaire during orthodontic treatment. So, this study aims to compare the changes in OHRQoL between patients receiving modified aligner appliances or conventional fixed appliances during orthodontic treatment.

There are two groups:

  1. Experimental group: the patients in this group will be treated using a modified aligner appliance.
  2. Control group: the patients in this group will be treated using conventional fixed appliances

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Most adult patients do not choose traditional fixed appliances due to concerns about appearance, lengthy treatment time, and challenges with oral hygiene. This study aimed to assess the impact on psychological well-being, aesthetics, and functionality of a novel single aligner appliance.

Study Type

Interventional

Enrollment (Actual)

36

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

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic
        • Department of Orthodontics, University of Damascus Dental School

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged between (18 - 25) years.
  2. Mild crowding < 4 mm in the lower dental arch with class I malocclusion
  3. No congenitally missing or extracted teeth (except for third molars)
  4. Patients with good oral hygiene.

Exclusion Criteria:

  1. Bimaxillary dentoalveolar protrusion.
  2. Previous orthodontic treatment.
  3. Severe skeletal discrepancy.

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: Modified aligner appliance with NiTi springs
The patients in this group will be treated using a Modified aligner appliance with NiTi springs.
Device: A modified aligner appliance with NiTi springs
The modified aligner appliance will be used until the final position is achieved.
Active Comparator: Conventional fixed appliances
The patients in this group will be treated using conventional fixed appliances.
Device: Conventional fixed appliances
The traditional fixed appliances with a standard prescription will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in oral health related quality of life
Time Frame: T0: immediately before the start of orthodontic treatment; T1: after two weeks; T2: after one months; T3: after two months; T4: post-treatment
Patients in both groups will receive a survey called the Oral-Health-Impact-Profile with 14 items (OHIP-14) to complete at every adjustment visit. The OHIP-14 questionnaire assesses various aspects of the individual's oral health, functional well-being, emotional well-being, expectations, and satisfaction with care, and sense of self through subjective evaluation. The total score can range from 0 to 56, with higher scores indicating poorer OHRQoL. Each domain within the OHIP-14 score is also rated on a scale of 0 to 8, with individual items contributing a score of 0 to 4.
T0: immediately before the start of orthodontic treatment; T1: after two weeks; T2: after one months; T3: after two months; T4: post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with the progress of the treatment
Time Frame: At the end of treatment which is expected to occur within 4 to 6 months
Patients in both groups will be asked one question about their satisfaction with the treatment's progress. This question records satisfaction using a 100 mm visual analog scale (VAS). The left end of the line refers to no satisfaction (VAS=0), whereas the right end refers to maximum satisfaction (VAS=100).
At the end of treatment which is expected to occur within 4 to 6 months
Patient satisfaction with the appearance of the orthodontic appliance
Time Frame: At the end of treatment which is expected to occur within 4 to 6 months
Patients in both groups will be asked one question about satisfaction with the appearance of the orthodontic appliance. This question records satisfaction using a 100 mm visual analog scale (VAS). The left end of the line refers to no satisfaction (VAS=0), whereas the right end refers to maximum satisfaction (VAS=100).
At the end of treatment which is expected to occur within 4 to 6 months
Patient satisfaction with the results of the treatment
Time Frame: At the end of treatment which is expected to occur within 4 to 6 months
Patients in both groups will be asked one question about their satisfaction with the treatment's results. This question records satisfaction using a 100 mm visual analog scale (VAS). The left end of the line refers to no satisfaction (VAS=0), whereas the right end refers to maximum satisfaction (VAS=100).
At the end of treatment which is expected to occur within 4 to 6 months

Collaborators and Investigators

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

Sponsor

Damascus University

Investigators

  • Principal Investigator: Ziad Mohamad Alhafi, DDS MSc, Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
  • Study Director: Nada Rajeh, DDS MSc PhD, Department of Orthodontics, Faculty of Dentistry, Damascus University
  • Study Chair: Mohammad Younis Hajeer, DDS MSc PhD, Department of Orthodontics, Faculty of Dentistry, Damascus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 2, 2022

Primary Completion (Actual)

February 13, 2023

Study Completion (Actual)

November 3, 2023

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • UDDS-Ortho-2-2024

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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