The Effect of a Newly Designed Presurgical Orthopedic Appliance

NCT ID: NCT05535530

Last Updated: 2022-09-21

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-09-01

Brief Summary

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A randomized clinical trial to compare the effectiveness of newly designed active type of presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.

Detailed Description

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It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: a passive orthopedic appliance will be used, and group two a new designed active orthopedic appliance will be used. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.

Conditions

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Cleft Lip and Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

Passive PSIO will be used

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental

Active PSIO will be used

Group Type EXPERIMENTAL

Active PSIO

Intervention Type DEVICE

new designed active orthopedic appliance will be used. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.

Interventions

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Active PSIO

new designed active orthopedic appliance will be used. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 1\. Healthy new born infants with complete bilateral cleft lip, alveolus and palate.

2\. Non-syndromic. 3. Non-operated cases.

Exclusion Criteria

* 1\. Infants with systemic syndromes. 2.Facial deformities.
Minimum Eligible Age

5 Days

Maximum Eligible Age

2 Months

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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Mushriq F. Abid

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mushreq Abed

Baghdad, Al-Rusafa, Iraq

Site Status

Countries

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Iraq

Other Identifiers

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262421

Identifier Type: -

Identifier Source: org_study_id

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