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.: PACTR201604001377321 Date of Registration: 04/12/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Modifying the BPOC for Nigeria by adding Scaling and Polishing
Official scientific title MODIFYING THE BASIC PACKAGE OF ORAL CARE FOR NIGERIA: ADDITION OF SCALING AND POLISHING AS A COMPONENT
Brief summary describing the background and objectives of the trial Background: The Basic Package of Oral Care (BPOC) was developed by the WHO in Netherlands to adapt conventional dentistry to the philosophy of Primary Health Care (PHC). The BPOC, while meeting its objectives, neglects tooth loss due to periodontal disease, presumably based on the assumption that periodontal diseases are not a major cause of tooth loss. Therefore, removing calculus from tooth surfaces is not considered a priority. While this may be true in developed countries where oral health awareness is rife, it does not hold true for most developing countries, including Nigeria. This study aims to determine the impact of the addition of S&P as a component to the BPOC on the periodontal health status, and the oral health attitudes and practices of rural dwellers at a rural PHC center in Kano state; and if the effects are large enough to warrant a formal modification of the BPOC for Nigeria. The study can provide a reference point for further modifications to suit other regions, or other distinct population subgroups, and may provide evidence for modification of the BPOC in Nigeria, as the country begins implementation of the National Oral Health Policy with integration of oral healthcare into the existing primary healthcare system. AIM: To determine the feasibility and effects of adding S&P to the BPOC in PHC settings, using a PHC in Kano, Nigeria as an illustration. MAJOR OBJECTIVE To compare the effects of modification of the BPOC by addition of S&P (with that of coventional BPOC) on the periodontal health status of a group of study subjects in Kano, Nigeria using the Oral Hygiene Index and Community Periodontal Index. MINOR OBJECTIVES To compare the effects on oral health attitudes of addition of S&P to the existing BPOC among a rural population in Nigeria. To compare the effects on oral health practices of addition of S&P to the existing BPOC among a rural population in Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MOBS
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 06/02/2017
Actual trial start date
Anticipated date of last follow up 30/06/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 78
Actual target sample size (number of participants)
Recruitment status Not yet 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
Parallel: different groups receive different interventions at same time during study Randomised Dynamic (adaptive) randomization by minimization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Basic Package of Oral Care Involves Oral Urgent Therapy, Atraumatic Restorative Therapy, Affordable Fluoride Therapy 39 Active-Treatment of Control Group
Experimental Group Modified Basic Package of Oral Care Involves Oral Urgent Therapy, Atraumatic Restorative Therapy, Affordable Fluoride Therapy AND Scaling and Polishing 118
Control Group Basic Package of Oral Care Involves Oral Urgent Therapy, Atraumatic Restorative Therapy, Affordable Fluoride Therapy 39 Historical
Experimental Group Modified Basic Package of Oral Care Involves Oral Urgent Therapy, Atraumatic Restorative Therapy, Affordable Fluoride Therapy AND Scaling and Polishing 39 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ All children or adults who present to the two community dental centers within the study period; ¿ All who accede and consent to the study. ¿ All who require referral for specialist or advanced dental care at a tertiary healthcare center; ¿ All who refuse to give consent. 15 Year(s) 150 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 07/05/2015 Aminu Kano Teaching Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
No 2, Zaria Rd., Kano Kano 700233 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improvement in Periodontal health status as measured by Oral Hygiene Index and Gingival Bleeding aspect of Community Periodontal Index After 1 month and 3 months
Primary Outcome Improvement in Periodontal health status as measured by Clinical Attachment Loss and Probing Depth aspect of Community Periodontal Index After 3 months
Secondary Outcome Improvement in Oral Health Attitudes and Practices After 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kumbotso Clinic, AKTH Kumbotso PHC Kumbotso, Kano 23400 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self No 2 Zaria Rd Kano 23400 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Aminu Kano Teaching Hospital Dental & Maxillofacial Unit No 2, Zaria Rd. Kano 700233 Nigeria Hospital
Primary Sponsor Self No 2 Zaria Rd Kano 23400 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Aderafel Adebola No 2 Zaria Rd Kano 23400 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joshua Adeoye joshuadeoye@gmail.com +2349099980889 15 Gyadi-Gyadi C
City Postal code Country Position/Affiliation
Kano 23400 Nigeria Senior Resident Doctor/Aminu Kano Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Joshua Adeoye joshuadeoye@gmail.com +2349099980889 15 Gyadi Gyadi C
City Postal code Country Position/Affiliation
Kano 23400 Nigeria Senior Resident Doctor/Aminu Kano Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Joshua Adeoye joshuadeoye@gmail.com +2349099980889 15 Gyadi Gyadi C
City Postal code Country Position/Affiliation
Kano 2 Nigeria Senior Resident Doctor/Aminu Kano Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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