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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609690479216 Date of Registration: 10/09/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Magnetic Habit Reminder in Cessation of Thumb Sucking Habit
Official scientific title Effectiveness of Magnetic Habit Reminder in Cessation of Thumb Sucking Habit
Brief summary describing the background and objectives of the trial Oral habits, such as finger sucking, can lead to significant changes in dental alignment. This habit can cause retroclination of the lower incisors and proclination of the upper incisors, resulting in an increased over jet and the development of a unilateral cross bite as the mandible shifts. Additionally, the habit can alter the ratio between the upper and lower anterior facial heights, leading to a forward positioning of the upper teeth compared to the lower teeth, which may contribute to an anterior open bite. Anterior open bite is a tricky problem for pediatric dentists as it causes aesthetic, speech, feeding, and psychological problems; this accentuates the early diagnosis and interception to eliminate this malocclusion. The study aims to evaluate the effectiveness of magnetic habit reminder versus blue grass in cessation of the thumb sucking habit.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/02/2024
Actual trial start date
Anticipated date of last follow up 15/07/2026
Actual Last follow-up date 15/07/2026
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL N/A
Secondary Ids Issuing authority/Trial register
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 Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Magnetic habit reminder N/A 6 months Primary impression to the upper arch Impression to the thumb that the child use in the habit Elastic separator Try in band Over impression Insertion of appliance 30
Control Group Bluegrass N/A 6 months Primary impression to the upper arch Elastic separator Try in band Over impression Insertion of appliance 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Normal class I molar relationship. - History of continuous thumb sucking associated with slight or moderate open bite from the habit . - Patient and parent cooperation. - No systemic diseases. - Lateral Cephalometric before insertion and after six months. . - Preoperative photography,1,3,6 months to evaluate open bite - Cast models before and after six months - Increased over jet with sever anterior open bite. - Extracted or missed upper 1st permanent molar and upper primary 2nd molar in one side. - Clift lip or palate. - History of previous orthodontic treatment. - Large skeletal deformity from the habit. - Severe open bite Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 5 Year(s) 7 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 01/01/2024 Research Ethics Committee Faculty of Dentistry Tanta University
Ethics Committee Address
Street address City Postal code Country
El Gash street Medical Campus Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Complete stoppage of thumb sucking habit. Within 6 months of beginning of treatment
Secondary Outcome Minimize the anterior open bite Within 6 months of beginning of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic of the Department of Pediatric Dentistry Faculty of Dentistry Tanta University El Gash street Medical Campus Tanta 31773 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mona Mostafa Mohamed Hasabo El-gemiza Elsanta 31631 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric Dentistry Department Faculty of Dentistry Tanta University. El Gash street Medical Campus Tanta 31773 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amina Mohamed Elnabawy Elhosary Elbahr street, Tanta university, Pediatric Dentistry Department Tanta 31773 Egypt
Shimaa Mostafa Hadwa Elbahr street, Tanta university, Pediatric Dentistry Department Tanta 31773 Egypt
Neveen Mohamed Fakhry Elbahr street, Tanta university, Pediatric Dentistry Department Tanta 31773 Egypt
Mona Mostafa Mohamed Hasabo El-gemiza Elsanta 31631 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amina Elhosary Amina.elhosary@den.tanta.edu.eg 00201006816569 Elbahr street, Tanta University, Pediatric Dentistry Department
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Professor of Pediatric Dentistry Faculty of Dentistry Tanta University
Role Name Email Phone Street address
Scientific Enquiries Shimaa Hadwa Shimaa.hadwa@dent.tanta.edu.eg 00201115535527 Elbahr street, Tanta University, Pediatric Dentistry Department
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Assistant Professor of Pediatric Dentistry Faculty of Dentistry Tanta University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: Immediately following publication with no end date. For anyone who wishes to access the data For any type (purpose) of analyses Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
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