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.: PACTR202307594421954 Date of Registration: 19/07/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical Comparison of Super Elastic Niti (SENT) And Heat-Activated Niti (HANT) in Tooth Alignment and Orthodontically Induced Root Resorption
Official scientific title Clinical Comparison of Super Elastic Niti (SENT) And Heat-Activated Niti (HANT) in Tooth Alignment and Orthodontically Induced Root Resorption
Brief summary describing the background and objectives of the trial Dental crowding is one of the most common forms of malocclusion. It's management involves the use of orthodontic appliances. A number of factors influence the ability of orthodontic appliances to resolve dental crowding, one of which is the type of archwires used. The aim of this study is to compare the clinical efficiency of super elastic Niti archwire and Heat activated Niti archwire in resolving anterior segment crowding, as well as assess the amount of root resorption seen in each case.
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 Diagnosis / Prognosis
Anticipated trial start date 01/10/2022
Actual trial start date 01/11/2022
Anticipated date of last follow up 31/05/2023
Actual Last follow-up date 30/06/2023
Anticipated target sample size (number of participants) 38
Actual target sample size (number of participants) 38
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group super elastic Nitinol archwire SENT At the start of orthodontic intervention; 0.014" SENT is used. The dimension of the archwire increases from 0.014'' at the start of the study, to 0.016'' and finally 0.018'' at the end of the study. in total 12 weeks. Each dimension of archwire is replaced with the next one at 4-week interval. 0.014" - 0 to 4 weeks 0.016" - 5 to 8 weeks 0.018" - 9 to 12 weeks SENT is a type of orthodontic archwire. Orthodontic archwires in conjunction with orthodontic brackets are used to manage various types of malocclusion in orthodontics, one of which is dental crowding. This study is assessing the alignment efficiency of Super elastic NiTi (SENT) and Heat activated NiTi (HANT) over a period of 12 weeks. SENT archwires will used in patients who have dental crowding and its alignment efficiency will be assessed. 19 Active-Treatment of Control Group
Experimental Group Heat activated NiTi HANT At the start of orthodontic intervention; 0.014" HANT is used. The dimension of the archwire increases from 0.014'' at the start of the study, to 0.016'' and finally 0.018'' at the end of the study. In total 12 weeks. Each dimension of archwire is replaced with the next one at 4-week interval. 0.014" - 0 to 4 weeks 0.016" - 5 to 8 weeks 0.018" - 9 to 12 weeks HANT is a type of orthodontic archwire. Orthodontic archwires in conjunction with orthodontic brackets are used to manage various types of malocclusion in orthodontics, one of which is dental crowding. This study is assessing the alignment efficiency of Heat activated NiTi (HANT) over a period of 12 weeks. HANT archwires will used in patients who have dental crowding and its alignment efficiency will be assessed. 19
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. The presence of Little’s Irregularity Index (LII) of 3.1 to 6.9mm (mild-moderate crowding) 2. Patients between the ages of 10 and 25 years 3. Presence of all anterior permanent teeth fully erupted in the arches 4. Patients who gave assent for the study 5. Patients who gave consent for the study 6. Cases that did not require extraction of teeth 1. Less than 3.0 mm and greater than 6.9mm of lower incisor crowding (LII) or with spaced incisors. 2. Patients with cranio-facial deformities, such as cleft lip and palate 3. Presence of an impacted teeth which may require exposure. 4. The presence of a lingually/palatally displaced tooth that cannot not be bonded on the initial bonding visit. 5. Patients on medications which are known to affect tooth movement e.g., bisphosphonates, NSAIDS 6. Patients who did not give assent/consent for the study. 7. Patients who had undergone previous orthodontic treatment 8. Patients with poor oral hygiene 9. Cases that required extraction of teeth 10. Patients with periodontally compromised teeth Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Child: 6 Year-12 Year 10 Year(s) 25 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 07/06/2022 LAGOS UNIVERSITY TEACHING HOSPITAL. HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
idi-araba surulere 101283 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess alignment efficiency of Super-elastic NiTi (SENT) and Heat-activated NiTi (HANT) arch wires in orthodontic patients, with mild to moderate incisor crowding, who are undergoing orthodontic therapy with fixed orthodontic appliances 4 weeks, 8 weeks and 12 weeks.
Secondary Outcome To assess biologic safety of Super-elastic NiTi (SENT) and Heat-activated NiTi (HANT) arch wires, by assessing the amount of root resorption in orthodontic patients, with mild to moderate incisor crowding, who are undergoing orthodontic therapy with fixed orthodontic appliances 12 weeks, at the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Orthodontic Unit. Department of Child dental Health. Lagos University Teaching Hospital Idi-araba Surulere 101283 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
DR BEN OKOYE ADAKU Department of Child Dental Health. Lagos University Teaching Hospital surulere 101283 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr BEN OKOYE ADAKU Department of Child dental Health. Lagos University Teaching Hospital sururlere 101283 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ADAKU BEN OKOYE adadirim@gmail.com +2348034188109 Department of Child Dental Health. Lagos University Teaching Hospital
City Postal code Country Position/Affiliation
surulere 101283 Nigeria Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries ADAKU BEN OKOYE adadirim@gmail.com +2348034188109 Department of Child dental Health. Lagos University Teaching Hospital
City Postal code Country Position/Affiliation
Surulere 101283 Nigeria resident doctor
Role Name Email Phone Street address
Public Enquiries IFEOMA UTOMI ifeomautomi@yahoo.com +2348022241783 Department of Child Dental Health. Lagos University Teaching Hospital
City Postal code Country Position/Affiliation
Surulere 101283 Nigeria Professor of Orthodontics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available. Study protocol, Statistical Analysis Plan, will also be available beginning 12 months and ending 36 months following article publication. These will be available to Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose Proposal should be directed to adadirim@gmail.com. To gain access, data requestors will need to sign a data access agreement Statistical Analysis Plan,Study Protocol Study protocol, Statistical Analysis Plan, will also be available beginning 12 months and ending 36 months following article publication. Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose
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