Two Methods of Lip Taping as a Presurgical Orthopedic Appliance

NCT ID: NCT05796336

Last Updated: 2024-04-08

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2024-05-01

Brief Summary

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A randomized clinical trial to compare the effectiveness of two methods of lip taping as a 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 with conventional steri strip, and group two will receive a passive orthopedic appliance with a custom-made tape consist of steri strip and orthodontic elastic. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two methods of taping 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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Passive lip taping

Will receive passive baby feeding plate and conventional steri strip

Group Type EXPERIMENTAL

Lip taping

Intervention Type DEVICE

Steri strip tape and passive baby feeding plate Two methods of lip taping will be used with passive baby feeding plate. 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.

Custom-made tape

will receive passive baby feeding plate and custom-made tape (Steri Srip and orthodontic elastics)

Group Type EXPERIMENTAL

Lip taping

Intervention Type DEVICE

Steri strip tape and passive baby feeding plate Two methods of lip taping will be used with passive baby feeding plate. 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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Lip taping

Steri strip tape and passive baby feeding plate Two methods of lip taping will be used with passive baby feeding plate. 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. Non-Syndromic infants with complete bilateral cleft lip and palate.
2. Both sexes.
3. Age range from 1-30 day

Exclusion Criteria

1. Infants with systemic syndromes.
2. infants with unilateral cleft
3. infants whom parents refuse to consent.
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Month

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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College of Dentistry

Baghdad, Al-Rusaffa, Iraq

Site Status RECRUITING

Countries

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Iraq

Central Contacts

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Mushriq Abid, PhD

Role: CONTACT

7718800706 ext. 00964

Facility Contacts

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Mushriq Abid, PhD

Role: primary

07718800706 ext. 00964

Other Identifiers

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765423

Identifier Type: -

Identifier Source: org_study_id

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