Deep Bite Correction Using Auxiliary Intrusion Cantilevers With Initial Archwires in Adolescents
1 other identifier
interventional
27
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Typical duration for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedFirst Submitted
Initial submission to the registry
December 8, 2022
CompletedFirst Posted
Study publicly available on registry
December 16, 2022
CompletedDecember 16, 2022
December 1, 2022
1.8 years
December 8, 2022
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
EXPERIMENTALPatients 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.
Routine leveling and alignment
ACTIVE COMPARATORPatients 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.
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.
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mona Elmaghraby, BDS
Faculty of Dentistry, Alexandria University, Egypt
- STUDY CHAIR
Hanan Ismail, PhD
Faculty of Dentistry, Alexandria University, Egypt
- STUDY DIRECTOR
Hassan Kassem, PhD
Faculty of Dentistry, Alexandria University, Egypt
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