Deep Bite Correction Using Auxiliary Intrusion Cantilevers With Initial Archwires in Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Deep Overbite
• Intervention / Treatment: Device: Auxiliary cantilever intrusion arches on initial archwires; Device: Routine leveling and alignment

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21527
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auxiliary intrusion cantilevers; 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; 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.
Active Comparator: Routine leveling and alignment; 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; 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.; Other Names: Relative Intrusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depth of curve of Spee	Measured on dental casts by summing the right and left side maximum depths from a flat plane formed by the tips of the mandibular incisors anteriorly and the distal cusp tips of the second molars posteriorly	six months
Depth of gingival sulcus	The sulcus depth was measured using Michigan O periodontal probe.	six months
Width of keratinized gingiva	Measured with the aid of periodontal probe from the free gingival margin to the mucogingival junction.	six months
Root resorption of lower incisors	Length of lower incisor roots was compared in before- and after-periapical radiographs taken with a paralleling technique.	six months

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): September 12, 2020
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: 0049-08/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No