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.: PACTR202309912835123 Date of Approval: 28/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparing the effects of Nickel Titanium (NiTi) coil springs and elastics on the dental skeletal and soft tissues in patients on braces.
Official scientific title Comparison of dentofacial and skeletal effects of intermaxillary NiTi coil springs and intermaxillary elastics in the treatment of Class II malocclusion among adolescents.
Brief summary describing the background and objectives of the trial Background: Diverse studies have been conducted on methods to correct class II malocclusion which include use of fixed functional appliances such as AdvanSync and forsus, fixed appliances therapy (either involving selective extractions of the bicuspids or non-extraction protocol) with inter-maxillary elastics; which is the most common of all treatment protocols, as well as Orthognathic surgery in severe cases. Subsequently, inter-maxillary elastics have been compared with other appliances in the literature based on the dentoskeletal effects, force degradation and patients’ compliance; which has majorly been the drawback of elastics. NiTi coil springs have been reported to be effective in the treatment of non-compliant Class II malocclusion patients. However, there is paucity of studies that compared the dentoskeletal effects against other Class II corrective devices. Therefore, this study aims to compare the dentofacial and skeletal effects of inter-maxillary Niti coil spring (CS™5) versus inter-maxillary elastics in the correction of class II malocclusion in patients undergoing non-extraction fixed appliance therapy. Objective: To determine and compare the dentofacial and skeletal changes obtained with the use of inter-maxillary elastics and NiTi coil spring (CS™5) in the correction of class II malocclusion in patients with non-extraction fixed appliance therapy.
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 02/08/2021
Actual trial start date 08/12/2021
Anticipated date of last follow up 01/08/2022
Actual Last follow-up date 28/04/2023
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 48
Recruitment status Completed
Publication URL
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Class II elastics Class II elastics will be worn Continuously 24 weeks Class II intermaxillary elastics will be worn by the patient continuously for 24 weeks and will only be removed during periods of toothbrushing. these elastics will be replaced every day by a new elastics 24 Active-Treatment of Control Group
Experimental Group Class II NiTi coil springs. CS™5 Class II NiTi coil springs attached continously for 24 hours 24 weeks CS™5 Class II NiTi coil springs will be fixed by the examiner on the archwire. this will be evauate at 8 weeks, 16 weeks and 24 weeks 24
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Class II Molar and/or canine relationship with at least half unit cusp disto-occlusion on one or both sides of the jaw. 2. Subjects aged 10-19years old 3. Presence of all permanent teeth up to first molar 4. Minimum overjet of 5mm 5. Subjects with complete pre-treatment records which are lateral cephalometric radiograph, study models and clinical photographs. 6. Subjects who have completed the levelling and alignment phase of non-extraction fixed orthodontic therapy with Roth 0.022 prescription and are on upper and lower 0.019x0.025-inch Stainless steel wires. 7. Subjects between 10-15years must give assent (Appendix 2) and subject’s parent must give consent. While subjects between 16-19years must give consent. 1. Subjects with syndromic or craniofacial abnormalities such as cleft lip and palate. 2. Subjects with missing permanent tooth not including second and third molars. 3. Subjects with missing or incomplete records. 4. Subjects with springs that showed permanent deformation at any of the recall visits. 5. Subjects allergic to latex and nickel titanium. 6. Subjects on routine medications such as contraceptives, bisphosphonates or non-steroidal anti-inflammatory drugs (NSAIDs). 7. Subjects not willing to participate in the study. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 10 Year(s) 19 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 19/11/2020 LASUTH health research ethics committee
Ethics Committee Address
Street address City Postal code Country
1-5, Oba Akinjobi road, Ikeja, Lagos state Ikeja 234 Nigeria
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 19/11/2020 LASUTH HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
1-5, Oba Adejobi Road, Ikeja, Lagos State Ikeja 234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Changes in skeletal, Dental, and soft tissues in Class II malocclusion baseline, 8weeks, 16weeks, 24 weeks
Secondary Outcome OHRQoL between both groups using OHIP-14 Baseline, 8weeks, 16weeks, 24 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos State University Teaching Hospital 1-5, Oba Akinjobi road, Ikeja Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
DR ESAN TOLULOPE BOLANLE Department of child Dental Health, LASUTH, 1-5, Oba Adejobi Road Ikeja Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Esan Tolulope Bolanle Department of child Dental Health, LASUTH, 1-5, Oba Adejobi Road Ikeja Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tolulope Esan tolulope_esan@yahoo.com 08090365545 Department of child Dental Health, LASUTH, 1-5, Oba Adejobi Road
City Postal code Country Position/Affiliation
Ikeja Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Tolulope Esan tolulope_esan@yahoo.com 08090365545 Department of child Dental Health, LASUTH, 1-5, Oba Adejobi Road
City Postal code Country Position/Affiliation
Ikeja Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Tolulope Esan tolulope_esan@yahoo.com 08090365545 Department of child Dental Health, LASUTH, 1-5, Oba Adejobi Road
City Postal code Country Position/Affiliation
Ikeja Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participants data will be shared excluding personal identification information Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years after completion of the study Controlled access, all data analysis allowed, official request to the principal investigator, access will be granted to participants within the field of orthodontics and other related fields
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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