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

NCT ID: NCT04468295

Last Updated: 2020-07-14

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-28

Study Completion Date

2022-03-28

Brief Summary

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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.

Detailed Description

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* 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.

Conditions

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Orthodontic Tooth Movement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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0.018-inch slot orthodontic bracket system

En-masse retraction using frictionless mechanics with 0.018-inch slot orthodontic bracket system.

Group Type EXPERIMENTAL

Bonding

Intervention Type PROCEDURE

Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018 inch

Leveling and alignment

Intervention Type PROCEDURE

Leveling and alignment till 0.016 x0.022 Ni Ti

Extraction

Intervention Type PROCEDURE

Extraction of maxillary 1st premolars

Retraction

Intervention Type PROCEDURE

En-masse retraction using 0.017x0.025 TMA T loop

Digital models

Intervention Type PROCEDURE

impression taking and digital scanning

measurement

Intervention Type PROCEDURE

Assessment the rate of retraction for 6 months

0.022-inch slot orthodontic bracket system

En-masse retraction using frictionless mechanics with 0.022-inch slot orthodontic bracket system.

Group Type ACTIVE_COMPARATOR

Bonding

Intervention Type PROCEDURE

Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018 inch

Leveling and alignment

Intervention Type PROCEDURE

Leveling and alignment till 0.016 x0.022 Ni Ti

Extraction

Intervention Type PROCEDURE

Extraction of maxillary 1st premolars

Retraction

Intervention Type PROCEDURE

En-masse retraction using 0.017x0.025 TMA T loop

Digital models

Intervention Type PROCEDURE

impression taking and digital scanning

measurement

Intervention Type PROCEDURE

Assessment the rate of retraction for 6 months

Interventions

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Bonding

Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018 inch

Intervention Type PROCEDURE

Leveling and alignment

Leveling and alignment till 0.016 x0.022 Ni Ti

Intervention Type PROCEDURE

Extraction

Extraction of maxillary 1st premolars

Intervention Type PROCEDURE

Retraction

En-masse retraction using 0.017x0.025 TMA T loop

Intervention Type PROCEDURE

Digital models

impression taking and digital scanning

Intervention Type PROCEDURE

measurement

Assessment the rate of retraction for 6 months

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Omar Abdelaziz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CEBC-CU-2020-07-09

Identifier Type: -

Identifier Source: org_study_id

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