NCT05286398

Brief Summary

This study aimed to evaluate clinically the "Alveolar extension" technique for palatoplasty in cases of primary closure of cleft palate regarding its effect on:

  1. 1.Eruption of Primary dentition.
  2. 2.Maxillary primary teeth undergoing eruption.
  3. 3.The maxillary arch growth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
Last Updated

March 23, 2022

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

March 7, 2022

Last Update Submit

March 22, 2022

Conditions

Cleft Palate

Keywords

Alveolar extension palatoplastyBardachCleft palate

Outcome Measures

Primary Outcomes (1)

  • eruption of primary molars

    eruption of primay canine and primary first molar

    6 month

Secondary Outcomes (1)

  • Growth

    6 monrth

Study Arms (3)

Control group

PLACEBO COMPARATOR
Diagnostic Test: Addition silicone impression

Bradach group

EXPERIMENTAL
Procedure: PalatoplastyDiagnostic Test: Addition silicone impression

AEP group

EXPERIMENTAL
Procedure: PalatoplastyDiagnostic Test: Addition silicone impression

Interventions

PalatoplastyPROCEDURE

Surgical closure of palatal defect

AEP groupBradach group
Addition silicone impressionDIAGNOSTIC_TEST

diagnostic impression for maxillary arch

AEP groupBradach groupControl group

Eligibility Criteria

Age9 Months - 14 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Both sexes.
  • The age range from 9-12 month.
  • Has a complete cleft palate.
  • Medically fit for general anesthesia.
  • Patients who haven't received any previous palatal repair.

You may not qualify if:

  • Syndromic patients.
  • Medically compromised patients contradicting operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakahliya, 35511, Egypt

Location

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
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 18, 2022

Study Start

December 22, 2019

Primary Completion

January 1, 2021

Study Completion

January 16, 2022

Last Updated

March 23, 2022

Record last verified: 2019-09

Locations

EG(1)