Comparison Between Effectiveness of Different Esthetic Orthodontic Appliances

NCT06803433 | Completed DMC

• 1 other identifier: 3-3-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness of active fixed lingual wire, removable aligners, and lingual braces in managing crowding of the lower anterior teeth resulting from relapse. The study intends to evaluate these interventions concerning the degree of alignment achieved in the lower anterior teeth, treatment duration, patient discomfort, patient acceptance, gingival inflammation and the cost effectiveness.

Conditions

Relapse of the Lower Anterior Teeth

Outcome Measures

Primary Outcomes (1)

• Resolution of lower anterior teeth crowding

  This outcome was detected through measurement of the mean change in the little irregularity index which is defined as the sum of the linear distances between the anatomical contact points of the mandibular incisors. The little irregularity index will be measured using 3shape ortho analyzer software.

  6 months

Secondary Outcomes (4)

• Treatment Duration

  6 months

• Patient expectations

  6 months

• Pain reported on Visual analogue scale

  This outcome will be recorded at 8 time points which are: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 and Day 14.

• Gingival inflammation

  This outcome will be recorded at 4 timepoints, Pre treatment, 4 weeks after treatment, 12 weeks after treatment, Post treatment or after 6 months of treatment.

Study Arms (3)

Aligners

EXPERIMENTAL

The upper and lower arches will be intra orally scanned followed by fabrication of in office aligners for the lower arch using 3shape software.

Device: Aligners

Lingual braces

EXPERIMENTAL

2D lingual braces will be indirectly bonded to the lower anterior teeth from canine to canine.

Device: Lingual braces

Active fixed lingual wire

ACTIVE COMPARATOR

A customized 14 nickel-titanium archwire was placed on the lingual surfaces of the lower anterior teeth and secured through ligature wires passing through the contact points.

Device: Active fixed lingual wire

Interventions

Aligners DEVICE

Lower arch in office aligners.

Aligners

Lingual braces DEVICE

Lingual braces bonded to the lower anterior teeth

Lingual braces

Active fixed lingual wire DEVICE

A customized 14 Niti lingual wire customized to the lingual surface of the lower anterior teeth and secured with ligature wires.

Active fixed lingual wire

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate lower incisors crowding. (Little irregularity index of 3-6 mm)
• Relapse from previous non extraction orthodontic treatment that finished at least 1 year before the study.
• Patient refuses to go through full comprehensive orthodontic treatment.

You may not qualify if:

• Extracted or missing lower incisor or lower canine.
• Orthodontic patients who experienced relapse and were treated with extractions.
• Medically compromised patients.
• Hypersensitivity or allergy to any material involved in the study.
• Patients suffering from any congenital, hereditary or systemic disease.
• Root resorption in lower anterior teeth.
• Carious or fractured lower anterior teeth.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Univeristy

Giza, Giza Governorate, 12613, Egypt

Location

Related Publications (5)

• Franchi L, Giuntoli F, Fortini A, Chiodo BP, Baccetti T. A simplified lingual technique. J Clin Orthod. 2010 Mar;44(3):183-9. No abstract available.

  PMID: 20575320 BACKGROUND

• Yu Y, Sun J, Lai W, Wu T, Koshy S, Shi Z. Interventions for managing relapse of the lower front teeth after orthodontic treatment. Cochrane Database Syst Rev. 2013 Sep 6;2013(9):CD008734. doi: 10.1002/14651858.CD008734.pub2.

  PMID: 24014170 BACKGROUND

• Liou EJ, Chen LI, Huang CS. Nickel-titanium mandibular bonded lingual 3-3 retainer: for permanent retention and solving relapse of mandibular anterior crowding. Am J Orthod Dentofacial Orthop. 2001 Apr;119(4):443-9. doi: 10.1067/mod.2001.111397.

  PMID: 11298318 BACKGROUND

• Little RM, Riedel RA, Artun J. An evaluation of changes in mandibular anterior alignment from 10 to 20 years postretention. Am J Orthod Dentofacial Orthop. 1988 May;93(5):423-8. doi: 10.1016/0889-5406(88)90102-3.

  PMID: 3163221 BACKGROUND

• Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod. 1975 Nov;68(5):554-63. doi: 10.1016/0002-9416(75)90086-x.

  PMID: 1059332 BACKGROUND

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: Dr

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: January 31, 2025
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)