Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201801002981142 Date of Approval: 17/01/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Conventional Fixed Tongue Crib versus Mini-screw Supported Tongue Crib in the Treatment of Patients in mixed dentition
Official scientific title Treatment effects of Conventional Fixed Tongue Crib versus Mini-screw Supported Tongue Crib in the Treatment of Patients in mixed dentition stage with Anterior Open Bite: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial The use of a conventional fixed tongue crib can successfully correct AOB, however, there is contradictory data as to whether it causes mesial movement of the upper maxillary first molar leading to a class II relationship and thus worsening the malocclusion. Meanwhile no study has tested the effectiveness of the mini-screw supported tongue crib in a large sample of patients. There is a gap in knowledge regarding the effectiveness of mini-screw supported tongue crib in closure of AOB, in addition to whether a conventional fixed tongue crib produces a class II malocclusion or not. Hence this study aims to test the effectiveness of both appliances as well as their anchorage load.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health,Tongue Crib
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/03/2018
Actual trial start date 03/09/2018
Anticipated date of last follow up 30/09/2019
Actual Last follow-up date 30/06/2021
Anticipated target sample size (number of participants) 26
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
nil known Orthodontic Department, Faculty of Dental Medicine, Cairo University
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using Excel software and Kutools Sealed opaque envelopes. Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Conventional Fixed Tongue Crib 9 months Conventional Fixed Tongue Crib soldered to the upper first molars 13
Experimental Group Mini-screw Supported Tongue Crib 9 months tongue crib on two mini-screws inserted paramedian 13
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Class I skeletal and dental Dental anterior open bite Maxillary and mandibular central incisor and lower first molars erupted Tongue thrust habit Good oral hygiene Systemic disease Severe crowding Missing teeth Previous orthodontic treatment Presence of posterior crossbites Child: 6 Year-12 Year 8 Year(s) 11 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/07/2018 Research Ethics Committee of the Faculty of Dentistry Cairo University
Ethics Committee Address
Street address City Postal code Country
11 EL-Saraya St. Manial Cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Parents¿ satisfaction at the end of treatment
Secondary Outcome Open-bite correction at the end of treatment
Secondary Outcome Amount of permanent maxillary first molar antero-posterior movement and tipping at the end of treatment
Secondary Outcome Soft tissue changes at the end of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Orthodontic Department, Faculty of Dental Medicine, Cairo University 11 El-Saraya St. - Manial Cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded 11 EL-Saraya St. Manial Cairo 11553 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of dentistry, Cairo University 11 EL-Saraya St. Manial Cairo 115533 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sherif Elkordy 11 EL-Saraya St. Manial Cairo 11553 Egypt
Mai Hamdy 11 EL-Saraya St. Manial Cairo 11553 Egypt
Khaled Hazem 11 EL-Saraya St. Manial Cairo 11553 Egypt
Amr Mohamed 11 EL-Saraya St. Manial Cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Fouda ahmed.fouda@dentistry.cu.edu.eg +201226226626 11 EL-Saraya St. Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Lecturer assisstant
Role Name Email Phone Street address
Public Enquiries Ahmed Fouda ahmed.fouda@dentistry.cu.edu.eg +201226226626 11 EL-Saraya St. Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Lecturer assistant
Role Name Email Phone Street address
Scientific Enquiries Ahmed Fouda ahmed.fouda@dentistry.cu.edu.eg +201226226626 11 EL-Saraya St. Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Lecturer assistant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information