NCT05405738

Brief Summary

comparison of the maxillary growth between cleft palate patients that underwent to repair by 2 flap palatoplasty versus Furlow with buccinator technique

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

May 22, 2022

Last Update Submit

September 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • maxillar growth

    evaluation of the maxillary growth through Inter-canine width (ICW) measurement by mm

    through study completion, an average one week

Study Arms (3)

normal group

Other: normal group

2flap palatoplasty group

Procedure: 2 flap palatoplasty technique

Furlow with buccinator group

Procedure: Furlow with buccinator technique

Interventions

cleft palate repair by 2 flap palatoplasty technique

2flap palatoplasty group

control normal group

normal group

cleft palate repair by Furlow with buccinator technique

Furlow with buccinator group

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

5-6ys old child with treated cleft palate

You may qualify if:

  • years old childreen with previous treated complete cleft lip and palate, nonsyndromic.
  • lip and palate repair performed by one craniofacial surgeon

You may not qualify if:

  • Patients with syndromic cleft lip.
  • Redu cases
  • Bilateral cleft lip
  • Patient older 6years or younger 5 years.
  • Associated Cardiac anomalies.
  • Any systemic condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

Location

Related Publications (1)

  • Aboulhassan MA, Refahee SM, Sabry S, Abd-El-Ghafour M. Effects of two flap palatoplasty versus furlow palatoplasty with buccal myomucosal flap on maxillary arch dimensions in patients with cleft palate at the primary dentition stage: a cohort study. Clin Oral Investig. 2023 Sep;27(9):5605-5613. doi: 10.1007/s00784-023-05182-0. Epub 2023 Aug 2.

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMouth AbnormalitiesMouth DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 22, 2022

First Posted

June 6, 2022

Study Start

May 6, 2022

Primary Completion

February 28, 2023

Study Completion

March 1, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations