Evaluation of the Rate of Maxillary En-masse Retraction Using 0.018-inch Versus 0.022-inch Slot Brackets in Adults

Evaluation of the Rate of Maxillary En-masse Retraction Using 0.018-inch Versus 0.022-inch Slot Brackets in Adult Patients With Maxillary Dentoalveolar Protrusion: A Randomized Clinical Trial

The study compares the rate of en-masse retraction using 0.018-inch versus 0.022-inch slot orthodontic bracket systems in adult patients with maxillary dentoalveolar protrusion.

Study Overview

• Status: Unknown
• Conditions: Orthodontic Tooth Movement
• Intervention / Treatment: Procedure: Bonding; Procedure: Leveling and alignment; Procedure: Extraction; Procedure: Retraction; Procedure: Digital models; Procedure: measurement

Detailed Description

• Proper examination of the oral structures is needed to identify caries, fracture or missing teeth.
• Full set of records ( study models, lateral cephalometric radiographs, photos) will be taken for every patient as part of the routine procedure for treatment of patients in the outpatient clinic of the Orthodontic Department, Cairo University.
• In intervention group: Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018-inch (American Orthodontics).
• In comparator group: Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.022-inch (American Orthodontics).
• Levelling and alignment in both groups with wire sequence: Ni-Ti (0.014,0.016, 0.016×0.022)
• Steel ligation of maxillary (2nd premolar, 1st molar and 2nd molar) for anchorage.
• Extraction of maxillary 1st premolars.
• Impression will be taken, poured in plaster from which digital models will be fabricated before beginning of en-masse retraction (the baseline model).
• Lateral cephalometric and periapical radiographs will be taken before starting retraction.
• En-masse retraction will be done using 0.017x0.025 TMA T-Loop10 in both groups, the loops will be reactivated monthly.
• Alginate impressions will be taken every month, that will be scanned to obtain digital models to assess the rate of retraction for 6 months.
• After 6 months, last obtained digital model will be evaluated for assessment of anchorage loss, and Lateral cephalometric and periapical radiographs will be taken to assess changes in the anterior teeth inclinations and apical root resorption respectively.
• The patients' treatment will be completed as indicated for them.

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Maxillary dentoalveolar protrusion cases that require upper first premolars extraction.
• Full permanent dentition (not necessitating third molars).
• Good oral hygiene.

Exclusion Criteria:

• Patients having systemic diseases or on medications that would affect tooth movement.
• Active periodontal disease or obvious bone loss in maxillary arch.
• Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
• Previous orthodontic treatment.
• Missing teeth.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 0.018-inch slot orthodontic bracket system; En-masse retraction using frictionless mechanics with 0.018-inch slot orthodontic bracket system.	Procedure: Bonding; Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018 inch; Procedure: Leveling and alignment; Leveling and alignment till 0.016 x0.022 Ni Ti; Procedure: Extraction; Extraction of maxillary 1st premolars; Procedure: Retraction; En-masse retraction using 0.017x0.025 TMA T loop; Procedure: Digital models; impression taking and digital scanning; Procedure: measurement; Assessment the rate of retraction for 6 months
ACTIVE_COMPARATOR: 0.022-inch slot orthodontic bracket system; En-masse retraction using frictionless mechanics with 0.022-inch slot orthodontic bracket system.	Procedure: Bonding; Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018 inch; Procedure: Leveling and alignment; Leveling and alignment till 0.016 x0.022 Ni Ti; Procedure: Extraction; Extraction of maxillary 1st premolars; Procedure: Retraction; En-masse retraction using 0.017x0.025 TMA T loop; Procedure: Digital models; impression taking and digital scanning; Procedure: measurement; Assessment the rate of retraction for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retraction Rate	The rate of en-masse retraction of the anterior teeth	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 28, 2020
• Primary Completion (ANTICIPATED): September 28, 2021
• Study Completion (ANTICIPATED): March 28, 2022

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (ACTUAL): July 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 10, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CEBC-CU-2020-07-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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