Evaluation of Segmented Versus Full Arch Three Dimensionally Printed Transfer Tray for Orthodontic Indirect Bonding

NCT ID: NCT03564717

Last Updated: 2018-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2018-12-30

Brief Summary

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This study is conducted to overcome the problems of conventional indirect bonding technique, through investigating accuracy of two novel three dimensionally digitally printed indirect bonding transfer trays (full arch \& segmented) in terms of accuracy of transferring brackets, rate of immediate bond failure and chair side time.

Detailed Description

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Fourteen patients (7 in each group) with mild to moderate crowding, requiring orthodontic treatment with full set of permanent teeth including second molars, will be selected for this study. A total of 196 brackets will be used (98 Full Arch Tray and 98 Segment Arch Tray). The same bracket type and bonding material will used in both groups. The accuracy of bracket transfer will be measured by 3 Shape Ortho planner software (Bracket Placement Module), rate of bond failure by counting number of debonded brackets upon tray removal \& chair side time by using digital watch.

Conditions

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Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding Tray Accuracy of Bracket Transfer and Bond Failure Rate of Full Arch and Segmented Digitally Printed Trays

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Segmented Three dimensionally printed transfer tray

Group Type EXPERIMENTAL

Segmented three dimensionally printed transfer tray

Intervention Type OTHER

Segmented indirect bonding transfer tray

Full arch three dimensionally printed transfer tray

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Segmented three dimensionally printed transfer tray

Segmented indirect bonding transfer tray

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients seeking fixed orthodontic treatment with full set of permanent teeth including second molars.
2. No sex predilection.
3. Mild to moderate crowding cases (4-6 mm).

Exclusion Criteria

1. Severely rotated teeth
2. Enamel hypoplasia or hypocalcification.
3. Systemic disease that contraindicates orthodontic treatment.
4. Presence of deep carious lesions or large restorations.
5. No or poor patient's compliance \& bad oral hygiene.
6. Psychological problems.
Minimum Eligible Age

16 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mariam Alaa

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CEBD-CU-2018-04-17

Identifier Type: -

Identifier Source: org_study_id

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