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.: PACTR202208919526312 Date of Registration: 30/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A COMPARATIVE EVALUATION OF THE EFFECTS OF MOLAR BANDS VERSUS BONDED TUBES ON PERIODONTAL STATUS AND ATTACHMENT FAILURES IN AN ORTHODONTIC POPULATION
Official scientific title A COMPARATIVE EVALUATION OF THE EFFECTS OF MOLAR BANDS VERSUS BONDED TUBES ON PERIODONTAL STATUS AND ATTACHMENT FAILURES IN AN ORTHODONTIC POPULATION
Brief summary describing the background and objectives of the trial The aim of the study is to compare the effects of molar bands and bonded buccal tubes on the periodontal status and attachment failure in adolescent and adult orthodontic patients, undergoing fixed appliance treatment over a 6 months period in Lagos University Teaching Hospital, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Periodontal disease
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/08/2022
Actual trial start date 30/07/2022
Anticipated date of last follow up 01/12/2022
Actual Last follow-up date 20/12/2022
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 52
Recruitment status Recruiting
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Buccal tube in fixed orthodontics appliance once six(6) months Molar bangs are used for conventional treatment of fixed orthodontics appliance however Buccal tubes is anticipated to be an alternative, hence this study 52
Control Group Molar bands once six months Molar bands are stainless steel bands used as abortment in fixed orthodontic appliances. 52 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients who were about to undergo fixed appliance orthodontic therapy (Pre-adjusted Edgewise) in both arches. • Patients: adolescents aged 10-17 years and adult patients aged 18-35 years. • Motivated and well informed patients. Information about the study were adequately communicated to patients and parents (with regard to adolescent patients). An informed consent form were obtained from these selected patients (Appendix 1) while Assent for under-aged patients.(Appendix 2) • Patients with no pre-existing periodontal disease. • Patients below 10 years or above 35 years. • Patients with history of Diabetes mellitus, blood dyscrasias or periodontitis. • Patients with other systemic diseases including cardiovascular diseases receiving anti-hypertensive medication among others. • Patients on antibiotics 3 months prior to treatment. • Patients requiring arch expansion (Occlusion that requires extra-oral and intra-oral anchorage reinforcement devices e.g., Nance, Transpalatal arch, Lingual holding arch). • Patients requiring distalization of the molars with other appliances. These were excluded to avoid other interferences of the oral flora during the course of this study so as not to affect the result obtained. • Patients with missing first permanent molars. • Patients with hypoplastic or demineralized molars. • Molars with heavy restorations or crowns. • Non-consenting patients. • Pregnant women. • Females on oral contraceptives. • Patients with para functional oral habits like bruxism • Patients with special needs. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 10 Year(s) 35 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 09/06/2022 Lagos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Idi-araba, Lagos Lagos 100001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Plaque accumulation, Gingival inflammation. Start, six weeks, twelve weeks, eighteen weeks, and twenty four weeks
Secondary Outcome Detachment from the teeth. Start, six weeks, twelve weeks, eighteen weeks and twenty four weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Orthodontics unit Lagos university teaching hospital Idi-araba, Lagos Lagos 100001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Chegwe Orthodontics unit Lagos university teaching hospital Lagos 100001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Chegwe Orthodontics unit Lagos university teaching hospital Lagos 100001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sylvester Chegwe schegwe@gmail.com +2347031095888 Orthodontics unit Lagos university teaching hospital
City Postal code Country Position/Affiliation
Lagos 100001 Nigeria National Post Graduate College of Nigeria
Role Name Email Phone Street address
Public Enquiries Gerald Isiekwe iisiekwe@unilag.edu.ng +2348052930439 Lagos university teaching hospital idi-araba, lagos nigeria
City Postal code Country Position/Affiliation
Lagos 100001 Nigeria supervisor
Role Name Email Phone Street address
Scientific Enquiries Oluranti Dacosta rantidacosta@gmail.com +2348023221208 Lagos university teaching hospital idi-araba, lagos nigeria
City Postal code Country Position/Affiliation
Lagos 100001 Nigeria supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Is participants willing for their data to be published? Yes Which data can be shared? Data that has been blinded to both operator and the participants What other documents will be available? Detailed statistical analysis When will data be available (start and end dates)? Data will be available six months post completion of study. With whom? Researchers who provide a methodologically sound proposal Any purpose? To achieve the objectives of the proposal in the approved proposal IPD sharing statement Informed Consent Form six months not applicable
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