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

Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding Tray Clinical Trial

Official title:

Evaluation of Segmented Versus Full Arch Three Dimensionally Printed Transfer Tray for Orthodontic Indirect Bonding: Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03564717
• Other study ID #: CEBD-CU-2018-04-17
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: June 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: December 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Segmented three dimensionally printed transfer tray
Segmented indirect bonding transfer tray

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of 3D printed full arch &segmented transfer tray.	Using Digital Measurements on 3shape software in mm- degrees	immediate
Secondary	Chairside Time	Digital stopwatch in seconds	immediate
Secondary	Immediate Bond Failure	Counting number of brackets or tubes failed immediately after bonding	immediate