Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Grayson Acrylic Formed Nasoalveolar Molding Appliances.

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04966572

Collaborator

(none)

Enrollment

Location

Arms

12.9

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either presurgical vacuum-formed nasoalveolar molding aligners VF (NAM) or conventional Grayson acrylic formed nasoalveolar molding appliances in order to evaluate their effect on the maxillary arch.

Condition or Disease	Intervention/Treatment	Phase
Cleft Lip and Palate Bilateral Cleft Lip/Palate	Device: Presurgical vacuum formed nasoalveolar molding aligners Device: Conventional Grayson acrylic formed nasoalveolar molding appliances	N/A

Detailed Description

The aim of this trial is to evaluate and compare the short-term effect of VF (NAM) aligners with conventional Grayson appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards maxillary arch changes.

Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive presurgical vacuum-formed nasoalveolar molding aligners while the second group will receive conventional Grayson acrylic formed nasoalveolar molding appliances. The follow-up period will be 4-6 months till surgical lip closure. The changes in the maxillary arch will be assessed by digital maxillary models.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

single blinded

Primary Purpose:

Treatment

Official Title:

Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Conventional Grayson Acrylic Formed Nasoalveolar Molding Appliances: A Randomized Clinical Trial

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Mar 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Presurgical vacuum formed nasoalveolar molding aligners group In this group, all patients will receive 1-2 VF-NAM aligners incorporated with palatal screw in addition to taping from day 1 for 4-6 Months with follow-up every 3 weeks	Device: Presurgical vacuum formed nasoalveolar molding aligners at first visit, the infants will receive this appliance which is a maxillary vacuum plate incorporated with palatal screw, the infant's parents will be instructed to activate the screw and apply horizontal tap which will be placed at the base of nose in order to approximate lip segments and to change tape daily. After that, The infants will be recalled one week after the first visit to add the nasal stents into the appliance.
Experimental: conventional Grayson acrylic formed nasoalveolar molding appliances group This group will receive conventional Grayson acrylic formed nasoalveolar molding appliances without taping except some cases, with follow up every week for activation.	Device: Conventional Grayson acrylic formed nasoalveolar molding appliances at first visit, the infants will receive this appliance which is a maxillary acrylic plate without adding taping, the infants will be recalled bi weekly for activating the appliance. When the cleft alveolar gap is reduced to 6mm or less, a pair of nasal stents will be added to mold the nasal cartilage. the infants will be followed up for 4-6 months.

Arm

Intervention/Treatment

Experimental: Presurgical vacuum formed nasoalveolar molding aligners group

In this group, all patients will receive 1-2 VF-NAM aligners incorporated with palatal screw in addition to taping from day 1 for 4-6 Months with follow-up every 3 weeks

Device: Presurgical vacuum formed nasoalveolar molding aligners

at first visit, the infants will receive this appliance which is a maxillary vacuum plate incorporated with palatal screw, the infant's parents will be instructed to activate the screw and apply horizontal tap which will be placed at the base of nose in order to approximate lip segments and to change tape daily. After that, The infants will be recalled one week after the first visit to add the nasal stents into the appliance.

Experimental: conventional Grayson acrylic formed nasoalveolar molding appliances group

This group will receive conventional Grayson acrylic formed nasoalveolar molding appliances without taping except some cases, with follow up every week for activation.

Device: Conventional Grayson acrylic formed nasoalveolar molding appliances

at first visit, the infants will receive this appliance which is a maxillary acrylic plate without adding taping, the infants will be recalled bi weekly for activating the appliance. When the cleft alveolar gap is reduced to 6mm or less, a pair of nasal stents will be added to mold the nasal cartilage. the infants will be followed up for 4-6 months.

Outcome Measures

Primary Outcome Measures

Changes in the maxillary arch [T1 and T2 (4- 6 months)]
they will be measured in mm by digital models

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 1 Month

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Non-syndromic Infants with complete BCLP infants
Infants less than 1 month of age
Males and females.
Infants with displaced premaxilla
Patients whose parents provided written consent for the study.

Exclusion Criteria:

Patients above 1 month of age
Syndromic and systemically ill infants.
Patients with unilateral cleft lip and palate.
Incomplete Cleft lip.
Medically compromised patients
Patient's/guardians who will be unwilling to go through the PNAM therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Study Director: Fatma Abdu Abdelsayed, Professor, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Khadega Ali Al Khateeb, Phd student, faculty of Dentistry, Cairo university, Cairo University

ClinicalTrials.gov Identifier:

NCT04966572

Other Study ID Numbers:

BCLP_ Grayson_ vacuum

First Posted:

Jul 19, 2021

Last Update Posted:

Jul 22, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Cleft Lip

Study Results

No Results Posted as of Jul 22, 2021