Clinical Effectiveness of Damon Ultima Vs Conventional Brackets Trial)

NCT ID: NCT05978817

Last Updated: 2024-01-12

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

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-05-01

Brief Summary

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Compare the clinical performance, root resorption and pain perception between passive self-ligating Damon Ultema vs conventional brackets.

Detailed Description

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Damon Ultima System was introduced and claimed to be the first true full expression orthodontic system designed for faster and more precise finishing. The brackets were completely reengineered to virtually eliminate play for precise control of rotation, angulation and torque. Moreover, the system used specially designed archwires regarding wire dimensions and shape to fulfill the manufacturers claim.

Conditions

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Skeletal and Dental CL I Malocclusion Moderate Crowding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Double (open label)

Study Groups

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Damon Ultima brackets

Damon Ultima brackets

Group Type EXPERIMENTAL

Damon Ultima bracket

Intervention Type DEVICE

It is metal twin bracket with their recommended arch wire

conventional Roth appliance

conventional Roth appliance

Group Type EXPERIMENTAL

Damon Ultima bracket

Intervention Type DEVICE

It is metal twin bracket with their recommended arch wire

Interventions

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Damon Ultima bracket

It is metal twin bracket with their recommended arch wire

Intervention Type DEVICE

Other Intervention Names

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conventional Roth appliance

Eligibility Criteria

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Inclusion Criteria

* 15-35 years of age patients who are healthy and without medications such as non-steroidal anti-inflammatory analgesics.
* Patients with Class I normal occlusion with moderate dental irregularity (with 4-6 irregularity index) requiring non-extraction treatment.
* Presence of all the permanent teeth apart from the third molars.
* Patients with good oral hygiene and periodontal health.
* Without previous orthodontic treatment/ functional appliances

Exclusion Criteria

Patients will be excluded from recruitment if he had sever skeletal discrepancy that requires orthognathic surgery.

• Patients who have cleft lip or palate, hypodontia, or hyperdontia
Minimum Eligible Age

15 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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Nawar Ahmed Abed

Dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dheaa H Al-Groosh, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Baghdad

Locations

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Nawar A jebory

Baghdad, , Iraq

Site Status RECRUITING

Countries

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Iraq

Central Contacts

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Nawar A jebory, PHD student

Role: CONTACT

07809752102 ext. Iraq/ Baghdad

Dheaa H Al-Groosh, PHD

Role: CONTACT

07737776503 ext. Iraq /Baghdad

Facility Contacts

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Nawar A jebory

Role: primary

07809752102

Dheaa H Al-Groosh

Role: backup

+9647737776503

Other Identifiers

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Damon Ultima brack treatment

Identifier Type: -

Identifier Source: org_study_id

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