Chairside Time and Bond Failure of Non Custom Versus Custom Base Orthodontic Attachments During Indirect Bonding

Chairside Time and Bond Failure of Non Custom Versus Custom Base Orthodontic Attachments During Indirect Bonding: A Randomized Clinical Trial

compare the chair side time, clinical orthodontic attachment bond failure and accuracy of transfer between non custom attachment base and custom attachment base indirect techniques.

Study Overview

• Status: Unknown
• Conditions: Orthodontic Appliance Complication
• Intervention / Treatment: Device: non custom base attachment; Device: custom base attachment

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Patients should have

1. Maxillary sound teeth and undergoing fixed orthodontic treatment.
2. Space problems ranging from spacing to mild crowding.
3. Good oral hygiene.

Exclusion Criteria:

1. Patients with partially erupted teeth in the maxillary arch .
2. Signs of caries, large restorations fluorosis, hypoplasia or abnormalities of crown morphology.
3. The need of banding.
4. Bad oral hygiene measures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: non custom base attachment	Device: non custom base attachment; non custom base attachment
Active Comparator: custom base attachment	Device: custom base attachment; custom base attachment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chair side time	using stopwatch	an average of 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
immediate bond failure	number of debonded attachments using hand instrument pressure	immediately after bonding

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy of orthodontic attachments transfer	linear (mm) scale using geomagic software	one day after bonding
accuracy of orthodontic attachments transfer	angular (degrees) scale using geomagic software	one day after bonding

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: November 25, 2017
• First Submitted That Met QC Criteria: December 2, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 2, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CEBC-CU-2017-11-13

Drug and device information, study documents

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