3-D Evaluation of Alveolar Bone Changes and Root Resorption After Traction of Buccally Displaced Maxillary Canines

NCT07399197 | Recruiting DMC

• 1 other identifier: OR:04/03/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study used CBCT images to investigate the alveolar bone changes and root resorption in unilateral buccally displaced maxillary canines and adjacent teeth before and after orthodontic traction of unilateral BDMCs. The CBCT images will also be used to compare these changes to the normal contralateral side. The study outcome is to compare the 3-D changes in the alveolar bone and dental roots between the 2 interventional techniques (segmentalT-loop and piggyback NiTi traction) methods.

Conditions

Malocclusion; Displaced Teeth

Keywords

Buccally Displaced Maxillary Canines; Alveolar Bone Changes; Root Resorption; Orthodontic Treatment

Outcome Measures

Primary Outcomes (2)

• Mean Change in the Alveolar Bone Thickness

  The mean change in the alveolar bone thickness will be measured in millimeters (mm) using CBCT scans.

  From baseline (before orthodontic traction) to the completion of orthodontic traction (an average of 8 months)

• Mean Change in the Alveolar Bone Height

  Alveolar bone height measured in millimeters (mm) using CBCT.

  Baseline and Month 8

Secondary Outcomes (2)

• Mean Change in Root Resorption

  Baseline and Month 8

• Difference Between Two groups in Alveolar Bone Dimension Changes

  Month 8 after the completion of canine traction.

Study Arms (2)

T-loop

ACTIVE COMPARATOR

In patients randomized to the frictionless group, T-loops were fabricated using 0.017 X 0.025-inch TMA wire. The posterior leg of the T-loops will be inserted in the auxiliary tube of the first molar, and the anterior leg engaged the canine bracket.

Device: T-loop

Piggyback double wire

ACTIVE COMPARATOR

In patients randomized to the piggyback double wire method, all teeth in both maxillary and mandibular arches will be bonded with preadjusted edgewise brackets from the 0.022- in-slot MBT system.

Device: Piggyback double wire

Interventions

T-loop DEVICE

Firstly, only the BDMC will be bonded with a preadjusted edgewise bracket from the 0.022-in-slot MBT system and cementing the trans palatal arch. Canine traction will be carried out by ligating the segmental T loop of 0.016×0.022 TMA wire on the BDMC and inserting the other end of the T loop in the maxillary first permanent molar tube. The segmented T loop will be activated by 2 mm per month and tightened posteriorly to the tube of the first permanent molar for approximately 3 months to move the canine. Once the BDMC is in the proper site in the maxillary arch, all teeth in both maxillary and mandibular arches will be bonded with preadjusted edgewise brackets from the 0.022-in-slot MBT system. Leveling and alignment will start with engaging 0.014-in NiTi arch wires in both arches.

T-loop

Piggyback double wire DEVICE

All teeth in both maxillary and mandibular arches will be bonded with preadjusted edgewise brackets from the 0.022- in-slot MBT system. Leveling and alignment will start with engaging 0.014-in NiTi arch wires in both arches, bypassing maxillary BDMC. The arch wire sequence will include 0.014-in NiTi, 0.016-inch NiTi, 0.016x0.022-inch NiTi. After the arches are properly aligned, the piggyback technique will be used on the maxillary arch, and the arch wire size will be increased to 0.016 x 0.016-inch stainless15 steel for the maxillary arch and ligating the accessory 0.012-inch NiTi round for BDMC traction.

Piggyback double wire

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Yemeni ethnic patients.
• Presence of unilateral BDMC.
• The presence of a properly positioned and normally erupted contralateral canine.
• Mild to moderate crowding.
• The need for fixed orthodontic treatment.
• No sagittal discrepancy

You may not qualify if:

• History of severe facial trauma.
• Previous orthodontic treatment.
• Presence of bilateral BDMC.
• Presence of developmental dental anomalies.
• Presence of facial syndromes and bone metabolism disease.

Sponsors & Collaborators

• Sana'a University: lead

Study Sites (1)

Sana'a University

Sanaa, Sana'a, 00967, Yemen

RECRUITING

MeSH Terms

Conditions

Malocclusion; Root Resorption

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Resorption

Study Officials

• Mohammed A Al-Hababy, MSc

  Sana'a University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed A Al-Hababy, MSc

CONTACT

00967- 777771166; mohammed.al-hababi@su.edu.ye

Fuad Luft Almutareb, Prf.

CONTACT

0967772275275; f.almotareb@su.edu.ye

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This clinical trial will use a randomized design with equal allocation in a 1:1 ratio, blinding, and paralleling two groups.Computer-generated random sequencing using Microsoft Office Excel will performed. Opaque sealed envelopes will be used for allocation concealment. Blinding of the participants and operator will not possible because of the nature of the study. Blinding of the result evaluation will be done through data concealment during assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Candidate in PhD of Orthodontics

Model Details: This clinical trial will use a randomized design with equal allocation in a 1:1 ratio, blinding, and paralleling two groups. The study will compare the treatment outcomes between the segmental T-loop and the piggyback double wire traction techniques. The study will use CBCT images to evaluate the 3-D changes in the alveolar bone and root length of the unilateral BDMCs and adjacent teeth before and after orthodontic traction and compare them with the normal contralateral canines and adjacent teeth.

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 10, 2026
• Study Start: March 2, 2026
• Primary Completion: August 2, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

YE (1)