NCT02881606

Brief Summary

Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1 presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM (CAD/NAM). The aim of the study is to compare between short term clinical effects of both interventions as regards alveolar alignment, nasal esthetics and interlabial gap.

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 not_applicable

Timeline
Completed

Started Dec 2016

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

First Submitted

Initial submission to the registry

August 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

December 3, 2019

Status Verified

December 1, 2019

Enrollment Period

2.2 years

First QC Date

August 24, 2016

Last Update Submit

December 1, 2019

Conditions

Cleft Lip and Palate

Outcome Measures

Primary Outcomes (1)

  • Alveolar alignment

    Reference points,lines and planes on digital models recording the symmetry and alignment of maxillary arch segments

    5-6 months

Secondary Outcomes (1)

  • Nasal and labial esthetics

    5-6 months

Study Arms (2)

Naso-alveolar molding (NAM)

ACTIVE COMPARATOR

Active plates and nasal stents (Grayson method)

Device: Naso-alveolar molding (NAM)

Computer aided design NAM (CAD/NAM)

ACTIVE COMPARATOR

Computer aided design active plates and nasal stents

Device: Computer aided design NAM (CAD/NAM)

Interventions

Naso-alveolar molding (NAM)DEVICE
Naso-alveolar molding (NAM)
Computer aided design NAM (CAD/NAM)DEVICE
Computer aided design NAM (CAD/NAM)

Eligibility Criteria

Age7 Days - 60 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Bilateral cleft lip and palate

You may not qualify if:

  • Patients without cleft palate Unilateral cleft lip Patients having systemic medical problems that contraindicate NAM treatment Patients with history of previous presurgical infant orthopedics Patients with history of any surgical procedures (ex: lip adhesion)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medicine, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Blinding was done for the plastic surgeon (care provider) during lip repair and for the outcome assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer at orthodontic department

Study Record Dates

First Submitted

August 24, 2016

First Posted

August 29, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2019

Study Completion

May 1, 2019

Last Updated

December 3, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

EG(1)