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.: PACTR202009612740603 Date of Approval: 16/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of a supervised oral hygiene program on the oral hygiene status of special needs children in Lagos State.
Official scientific title Impact of a supervised oral hygiene regimen on the oral hygiene status of special needs children in Lagos State.
Brief summary describing the background and objectives of the trial Children with special needs are an important underserved population and are at risk for oral diseases.Plaque control is critical to maintaining good oral health and is best achieved through toothbrushing.However many children lack the ability to carry oral hygiene maintenance for themselves and rely on caregivers who themselves may also be deficient in knowledge and skills to carry out oral hygiene. Objective: To determine the impact of a supervised oral hygiene program on the oral hygiene status of special needs children.
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 Education /Training
Anticipated trial start date 02/03/2019
Actual trial start date 09/03/2019
Anticipated date of last follow up 09/11/2019
Actual Last follow-up date 23/11/2019
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants) 106
Recruitment status Completed
Publication URL Unpublished
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Oral health education Oral health education was given once to caregivers and children at beginning of the study. Onve, Day 1. The children had an oral hygiene and gingival status examination done. A didactic oral health education was given to caregivers and children and oral hygiene prophylaxis performed for the children and caregivers. Appropriate toothbushes and fluoride containing toothpaste given and oral hygiene and gingival status measured at day 1, one month, three months and six months. 54 Active-Treatment of Control Group
Experimental Group Oral health education and supervised toothbrushing. Oral health education given once at beginning of study, day 1. Supervision of toothbrushing by caregivers for their children once weekly for three months Oral health education was given to caregivers and children once at beginning of study just as done for control.Supervision of caregivers toothbrushing for their children done once weekly for three months. Oral hygiene and gingival status examination was done at beginning of study. Then oral health education given once and oral prophylaxis carried outi for children and caregivers.Appropriate toothbrushes and fluoridated toothpaste was given. Supervision of caregivers toothbrushing for their children was conducted once weekly for three months. Assessment of children's oral hygiene and gingival status was done at day before and after prophylaxis, one month, three months and at six months. 54
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting caregivers of functionally dependent children with special needs. Functionally dependent children according to WHO criteration. Children with parental consent. Children with no known acute or compromising medical condition. Non consenting caregivers Non assenting children. Critically or acutely ill children Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 6 Year(s) 18 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 12/12/2018 Lagos University Teaching Hospital health research ethicshows committee
Ethics Committee Address
Street address City Postal code Country
Ishaga road Surulere 101283 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improvement in oral hygiene status of children One month, three and six months respectively.
Secondary Outcome Improvement in oral hygiene knowledge and practice of caregivers for their children One month, three and six months respectively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Heart of gold hospices. Alhaji Masha street Surulere 101283 Nigeria
Lady Atinuke Oyindamola Memorial home. 4 David Akere let Street, Badagry. 103101 Nigeria
Ketu Special Children Center Barrel. Yaba. 101212 Nigeria
Modupe Cole memorial childcare and treatment home. 1 st Finnart college road Akoka 101212 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ekowmenhenhen Uyi Idah Preventive Dentistry Department, Luth. Idiaraba 101283 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ekowmenhenhen Uyi Idah 97 RMO4, Luth. Surulere 101328 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Daramola Opeyemi Preventive dentistry department, Luth/cmul. Surulere 101283 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Uyi Ekowmenhenhen Chiefidahu@gmail.com 2347037662079 RMO4, Luth.
City Postal code Country Position/Affiliation
Surulere 101283 Nigeria Senior registrar
Role Name Email Phone Street address
Public Enquiries Aisha Tayo Adewale aishaelabor@yahoo.com 2348023337347 Preventive Dentistry dept, Luth/cmul.
City Postal code Country Position/Affiliation
Surulere 101283 Nigeria Fellow
Role Name Email Phone Street address
Scientific Enquiries Opeyemi Daramola Opeyemidaramola1985@gmail.com 08029335798 Preventive Dentistry dept, Luth.
City Postal code Country Position/Affiliation
Surulere 101283 Nigeria Senior registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I am willing to provide all individual participant data collected during the trial, after deindentification. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available 9 months after publication and end 36 months after publication. Investigators whose proposed use of data has been approved by an independent review committee identified for such purpose shall be granted access.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Proposal may be directed to: Chiefidahu@gmail.com Yes 02/09/2020
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