NCT05654558

Brief Summary

The purpose of this study was to determine the effect of auxiliary intrusion cantilevers used with resilient archwires during the leveling and alignment phase in intruding lower incisors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
Last Updated

December 16, 2022

Status Verified

December 1, 2022

Enrollment Period

1.8 years

First QC Date

December 8, 2022

Last Update Submit

December 8, 2022

Conditions

Outcome Measures

Primary Outcomes (7)

  • Overbite

    Distance between incisal edges of upper and lower incisors measured on lateral cephalometric x-rays

    six months

  • True incisor intrusion

    Perpendicular distance between the center of resistance of mandibular central incisor and the mandibular plane measured on lateral cephalometric x-rays

    six months

  • Proclination of lower incisors

    Angle formed by the long axis of mandibular central incisor and mandibular plane measured on lateral cephalometric x-rays

    six months

  • Lower incisor intrusion and proclination

    Perpendicular distance between the incisal edge of the lower central incisor and mandibular plane measured on lateral cephalometric x-rays

    six months

  • Lower incisor intrusion

    Perpendicular distance between the apex of the lower central incisor and mandibular plane measured on lateral cephalometric x-rays

    six months

  • Extrusion of lower first molar

    Perpendicular distance between the mesio-buccal cusp tip of the lower first molar and mandibular plane measured on lateral cephalometric x-rays

    six months

  • Distal tip of lower first molar

    Angle formed between the long axis of lower 1st molar and mandibular plane measured on lateral cephalometric x-rays

    six months

Secondary Outcomes (4)

  • Depth of curve of Spee

    six months

  • Depth of gingival sulcus

    six months

  • Width of keratinized gingiva

    six months

  • Root resorption of lower incisors

    six months

Study Arms (2)

Auxiliary intrusion cantilevers

EXPERIMENTAL

Patients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription. Lower first molars received double tubed bands while 2nd molars received single bondable tubes. Leveling and alignment phase then started with 0.014 inch NiTi wires engaging all teeth and synched behind 2nd molars. Two 0.017" x 0.025" TMA (Ormco) sectional wires were attached to auxiliary tubes on 1st molars with tip back bends mesial to the molars and attached with hooks distal to lateral incisors on top of basal leveling arch wire. Amount of intrusive force was measured to range between 20 and 40 grams per side. Basal leveling arches were upgraded whenever needed. All patients were assessed after 6 months of treatment.

Device: Auxiliary cantilever intrusion arches on initial archwires

Routine leveling and alignment

ACTIVE COMPARATOR

Patients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription, 1st and 2nd molars received tubes or bands according to each patient's further needs Lower arch was leveled and aligned with sequential wires starting with 14 NiTi and upgraded when needed. All patients were assessed after 6 months of treatment.

Device: Routine leveling and alignment

Interventions

Patients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription. Lower first molars received double tubed bands while 2nd molars received single bondable tubes. Leveling and alignment phase then started with 0.014 inch NiTi wires engaging all teeth and synched behind 2nd molars. Two 0.017" x 0.025" TMA (Ormco) sectional wires were attached to auxiliary tubes on 1st molars with tip back bends mesial to the molars and attached with hooks distal to lateral incisors on top of basal leveling arch wire. Amount of intrusive force was measured to range between 20 and 40 grams per side. Basal leveling arches were upgraded whenever needed. All patients were assessed after 6 months of treatment.

Auxiliary intrusion cantilevers

Patients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription, 1st and 2nd molars received tubes or bands according to each patient's further needs Lower arch was leveled and aligned with sequential wires starting with 14 NiTi and upgraded when needed. All patients were assessed after 6 months of treatment.

Also known as: Relative Intrusion
Routine leveling and alignment

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Permanent dentition present except for third molars
  • No history of previous orthodontic treatment.
  • Class I or II malocclusion with minimal or no lower anterior crowding (\<3 mm)
  • Excessive overbite (\>3 mm).

You may not qualify if:

  • Syndromic patients as well as individuals with skeletal asymmetry
  • Endodontically treated or periodontally involved loweranterior teeth.
  • Need for tooth extraction in the lower arch.
  • Agenesis (except for third molars)
  • Any kind of tooth/root shape anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Location

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class IIMalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Mona Elmaghraby, BDS

    Faculty of Dentistry, Alexandria University, Egypt

    PRINCIPAL INVESTIGATOR
  • Hanan Ismail, PhD

    Faculty of Dentistry, Alexandria University, Egypt

    STUDY CHAIR
  • Hassan Kassem, PhD

    Faculty of Dentistry, Alexandria University, Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc candidate, Orthodontics Department, Faculty of Dentistry, Alexandria University

Study Record Dates

First Submitted

December 8, 2022

First Posted

December 16, 2022

Study Start

September 12, 2020

Primary Completion

June 15, 2022

Study Completion

June 30, 2022

Last Updated

December 16, 2022

Record last verified: 2022-12

Locations