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.: PACTR202403582913859 Date of Approval: 14/03/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of bonded lingual spurs with low trans palatal arch on developing anterior open bite
Official scientific title Effect of bonded lingual spurs with low trans palatal arch on developing anterior open bite: A randomized controlled trial
Brief summary describing the background and objectives of the trial Anterior open bite is a common malocclusion in growing patients: treatment of developing anterior open bite is considered one of the most challenging situations in daily clinical practice .one of the approaches used to address it, is the use of anterior tongue spurs. The cause of open bite is thought to be multifactorial involving altered function and vertical growth pattern ,anterior tongue rest posture is an etiological factor that has largely been overlooked in both conventional and surgical orthodontic treatment ,due to the long duration of this pressure even if it is very light pressure could affect tooth position both vertically and horizontally Some clinicians are worried of using a banded type of spur appliance due to anticipated negative patient reaction due to pain and serious injury have been inflicted on children because of this ,the hope is to achieve increases in overbite similar to those achieved with the banded appliances using bondable lingual tongue spurs. Traditional TPA is thought to have an effect on the vertical control of the molars or cause even intrusion by the deglutition mechanism which begins by increasing the palatal contact of the tongue from front to back . The basis of the tongue is moved forcibly upward and backward toward the hard palate ,sweeping the fluid backward down the pharynx ,this kind of tongue movement creates a considerable force on the hard palate and the alveolar ridge and any dental appliance positioned in its way during smiling. Because of this ,the hope is to achieve increase n the overbite similar to those achieved by banded appliance using bondable lingual tongue spurs and low trans palatal arch. The aim of this study is to evaluate the treatment effect of bonded fixed lingual spurs with low trans palatal arch with modified tongue pad on reducing the developing anterior open bite in mixed dentition stage and molar intrusion and counter clock wise rotation of the mandible, and to asses the
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 01/02/2022
Actual trial start date 01/02/2022
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Low transpalatal arch with lingual tongue spurs N/A 6 months Low transpalatal arch with lingual tongue spurs will be applied for 6 months 12
Control Group Tongue spurs only N/A 6 months Tongue spurs will be applied for 6 months 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Anterior open bite equal to or greater than 1 mm (1-5),limited to the anterior segment within the area of incisors and canines - Fully erupted maxillary and mandibular incisors as well as first molar . - Congenital missing teeth - Dental anomalies - Presence of any systemic diseases Child: 6 Year-12 Year 7 Year(s) 12 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 17/01/2021 Institutional Review Boards IRB at the faculty of dentistry Alexandria University IRB NO 031312021 IORG 0008839
Ethics Committee Address
Street address City Postal code Country
Champollion St., Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Open bite correction Pre treatment and 6 months after treatment
Primary Outcome Amount of permanent maxillary molar intrusion Pre treatment and 6 months after treatment
Secondary Outcome Parents satisfactions 6 months after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic in Orthodontic Department in Faculty of Dentistry Alexandria university Champollion Street Alexandria University Faculty of Dentistry Azaritya Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Moataz Nasser Elshayeb Champollion Street Alexandria University Faculty of Dentistry Azaritya Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Orthodontics Department Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandri a 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hanan Ismail Champollion Street Alexandria University Faculty of Dentistry Azaritya Alexandria 21521 Egypt
Tarek Nasreldin yousry Champollion Street Alexandria University Faculty of Dentistry Azaritya Alexandria 21521 Egypt
Moataz Nasser Elshayeb Champollion Street Alexandria University Faculty of Dentistry Azaritya Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hanan Ismail Hanan.ismail@dent.alex.edu.eg 00201223525181 Champollion Street Alexandria University Faculty of Dentistry Azaritya
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Orthodontics Faculty of Dentistry Alexandria University Egypt
Role Name Email Phone Street address
Scientific Enquiries Tarek Nasreldin tarek.nasreldin@alexu.edu.eg 00201001373737 Champollion Street Alexandria University Faculty of Dentistry Azaritya
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Assistant Professor of Orthodontics Faculty of Dentistry Alexandria University Egypt
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