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.: PACTR202201662414178 Date of Approval: 24/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Canine retraction rate using Micro Osteoperforation
Official scientific title Evaluation of canine retraction rate in adult orthodontic patients using miniscrew-facilitated micro osteoperforation: a split-mouth randomized clinical study
Brief summary describing the background and objectives of the trial BACKGROUND Despite the ever growing number of adult patients interested in orthodontic care, the long duration of fixed orthodontic cares continues to be a source of concern to these patients. Also of concern to the Orthodontist are complications like gingival recession, enamel decalcification, root resorption and even dental caries which may be associated with prolong treatment. Several adjunctive modalities or treatment procedures which could be surgical or non-surgical have been suggested to help reduce appreciably this treatment duration. Some of these modalities especially the non-surgical ones did not reduce the treatment time at all or significantly while the surgical options where too invasive and therefore, had poor patients acceptance added to the comorbidity associated with them. Therefore, micro osteoperforation (MOP) which is an easy, efficient and flapless minimal invasive chair side procedure involves the puncturing of alveolar cortical plate of bone to encourage faster modeling and remodeling is gaining wide acceptance as an efficient and effective adjunctive procedure to shorten orthodontic treatment time. This study will therefore help to verify if adjunctive use of miniscrew facilitated MOP can help increase canine retraction rate among Nigerian adult orthodontic patients. OBJECTIVES The aim of this study is to determine if adjunctive use of miniscrew facilitated MOP performed in adult patients undergoing fixed orthodontic appliance with bilateral first premolar extractions in one or both arches had a significant impact in increasing their canine retraction rate.
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: Surgery
Anticipated trial start date 01/06/2020
Actual trial start date 01/06/2020
Anticipated date of last follow up 02/08/2021
Actual Last follow-up date 15/12/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 58
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Microosteoperforation with NiTi closed coil springs 12 weeks Participants had Micro-osteoperforation with NiTi close coil spring at the start of the intervention 14
Experimental Group Microosteoperforation with NiTi closed coiled spring 12 weeks participants had NiTi close coil spring with two microosteoperation at the start of intervention and 8 weeks during intervention 14
Control Group NiTi Closed coil spring 12 weeks participants had NiTi closed coil spring at the start of intervention 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients aged 18years and above who were undergoing fixed orthodontic treatment at the University of Benin Teaching Hospital Benin City, Edo State 2. Patients who underwent bilateral extraction of the first premolars in either one or both arches. 3. Patients who had not previously undergone fixed orthodontic treatment 4. Patients with no systemic disease 5. Patients with no known bone pathology 6. Patients with no active periodontal disease 7. Patients who do not use tobacco 1. patients who had history of prolong use of antibiotics, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blocker 2. Patients who had poor oral hygiene even after motivation to maintain a good oral hygiene. 3. Patients who had evidence of significant bone loss around the canines radiographically 4. Patients who had positive history of past and or present periodontal disease, 5. Patients who had transalveolar extraction of their first premolars were excluded from the study 6. Patients who had evidence of active dental caries Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 33 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 09/01/2020 Health Research Ethics Committee University of Benin Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Ugbowo Benin City 1111 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Canine retraction rate 8 weeks, 12 weeks
Secondary Outcome Pain following Microosteoperforation 24hours, 3 days, 7 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Orthodontic clinic University of Benin Teaching Hospital Ugbowo Benin Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ojebor Hillary Smith Department of preventive dentistry, university of Benin Teaching Hospital, Ugbowo Benin Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ojebor Hillary Smith Department of Preventive dentistry, University of Benin Teaching hospital, Ugbowo Benin City Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hillary Ojebor ojhillsmithn@yahoo.com +2348060352699 Department of preventive dentistry, University of Benin Teaching Hospital, Ugbowo
City Postal code Country Position/Affiliation
Benin City Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Hillary Ojebor ojhillsmithn@yahoo.com +2348060352699 Department of preventive dentistry, University of Benin Teaching Hospital, Ugbowo
City Postal code Country Position/Affiliation
Benin city Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Hillary Ojebor ojhillsmithn@yahoo.com +2348060352699 Department of preventive dentistry, University of Benin Teaching Hospital, Ugbowo
City Postal code Country Position/Affiliation
Benin City Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data excluding the personal identification information, and results of investigation will be shared, Clinical Study Report,Informed Consent Form,Study Protocol it will be available within 1 year of completion of study access is controlled, permission will be granted by the principal investigator to researchers in the field of orthodontics
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