Evaluation of Fixed Mandibular Retainer Using 3D Printed Positioning Tray Versus Direct Bonding Technique

NCT03572179 | Completed

• 1 other identifier: CEBD-CU-2018-04-28
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Although there are many studies in the literature concerning methods of bonding of mandibular retainers whether directly or indirectly, there is a very limited evidence regarding their chair side time and bond failure. Also there are scarce data on fixed mandibular retainers bonded using 3D printed positioning tray.Thus, conducting a well-designed randomized clinical trial evaluating the chair side time and bond failure of 3d printed positioning tray and direct bonding method of fixed mandibular retainer.Null hypothesis is thatThe time needed for direct indirect bonding using 3D digital positioning tray of a mandibular fixed retainer is shorter than the time needed for direct bonding, and there is no difference in failures between the 2 bonding methods

Conditions

Orthodontic Appliance Complication

Keywords

3d printed positioning tray

Outcome Measures

Primary Outcomes (1)

• chairside time

  chairside time for bonding fixed lingual mandibular retainer using stopwatch in measured seconds

  follow up up to 6 month

Secondary Outcomes (1)

• bond failure

  6 month follow up

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

After finishing orthodontic treatment, all patient will receive a modified indirect technique for bonding fixed mandibular retainer and the key of modification is the fabrication of 3D printed digital positioning tray for placement of retainer with holes for composite pads for its direct application using 3 shape Ortho analyser Software ® instead of conventional indirect retainer fabrication method

Device: 3d printed positioning tray

Control Group

NO INTERVENTION

All patients of this group will follow conventional steps of direct bonding procedure of fixed mandibular retainer

Interventions

3d printed positioning tray DEVICE

3d printed positioning tray for lingual fixed retainer placement in treatment group

Treatment Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with properly finished orthodontic treatment according to ABO standards.
• the presence of the 4 mandibular incisors and the 2 mandibular canines,
• No active caries, restorations, fractures, or periodontal disease of these teeth
• Patient with Good oral hygiene

You may not qualify if:

• Patients with no need of fixed bonded mandibular retainer
• No or poor patient's co operation
• Abnormal morphology of anterior teeth
• Bad oral hygiene

Sponsors & Collaborators

• Raghda Alaa: lead

Study Sites (1)

Cairo University Faculty of Oral and Dental Medicine

Cairo, 0202, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants Patients can detect the transfer tray so blinding is not possible Operator The main operator is responsible for the bonding so the blinding is not possible Assessor The assessor (different from main operator will carry out the measurement blindly
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: all patient will receive a modified indirect technique for bonding fixed mandibular retainer and the key of modification is the fabrication of 3D printed digital positioning tray for placement of retainer with holes for composite pads for its direct application using 3 shape Ortho analyser Software ® instead of conventional indirect retainer fabrication method

Study Record Dates

• First Submitted: June 9, 2018
• First Posted: June 28, 2018
• Study Start: March 1, 2019
• Primary Completion: March 1, 2019
• Study Completion: March 28, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)