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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Auxiliary cantilever intrusion arches on initial archwires

Routine leveling and alignment

About this trial

This is an interventional treatment trial for Deep Overbite

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Auxiliary intrusion cantilevers

Routine leveling and alignment

Arm Description

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.

Outcomes

Primary Outcome Measures

Overbite

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

True incisor intrusion

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

Proclination of lower incisors

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

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

Lower incisor intrusion

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

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

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

Secondary Outcome Measures

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

Depth of gingival sulcus

The sulcus depth was measured using Michigan O periodontal probe.

Width of keratinized gingiva

Measured with the aid of periodontal probe from the free gingival margin to the mucogingival junction.

Root resorption of lower incisors

Length of lower incisor roots was compared in before- and after-periapical radiographs taken with a paralleling technique.

Full Information

NCT ID

NCT05654558

First Posted

December 8, 2022

Last Updated

December 8, 2022

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT05654558

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

September 12, 2020 (Actual)

Primary Completion Date

June 15, 2022 (Actual)

Study Completion Date

June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deep Overbite

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Auxiliary intrusion cantilevers

Arm Type

Experimental

Arm Description

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.

Arm Title

Routine leveling and alignment

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Auxiliary cantilever intrusion arches on initial archwires

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Routine leveling and alignment

Other Intervention Name(s)

Relative Intrusion

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overbite

Description

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

Time Frame

six months

Title

True incisor intrusion

Description

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

Time Frame

six months

Title

Proclination of lower incisors

Description

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

Time Frame

six months

Title

Lower incisor intrusion and proclination

Description

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

Time Frame

six months

Title

Lower incisor intrusion

Description

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

Time Frame

six months

Title

Extrusion of lower first molar

Description

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

Time Frame

six months

Title

Distal tip of lower first molar

Description

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

Time Frame

six months

Secondary Outcome Measure Information:

Title

Depth of curve of Spee

Description

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

Time Frame

six months

Title

Depth of gingival sulcus

Description

The sulcus depth was measured using Michigan O periodontal probe.

Time Frame

six months

Title

Width of keratinized gingiva

Description

Measured with the aid of periodontal probe from the free gingival margin to the mucogingival junction.

Time Frame

six months

Title

Root resorption of lower incisors

Description

Length of lower incisor roots was compared in before- and after-periapical radiographs taken with a paralleling technique.

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mona Elmaghraby, BDS

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hanan Ismail, PhD

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Hassan Kassem, PhD

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Dentistry, Alexandria University

City

Alexandria

ZIP/Postal Code

21527

Country

Egypt

Deep Overbite

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial