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.: PACTR202305892616028 Date of Approval: 23/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of periodontal health and oral health status in adult individuals using charcoal infused toothbrush and regular nylon bristle toothbrush in a Nigerian tertiary hospital.
Official scientific title Comparison of periodontal health and oral health status in adult individuals using charcoal infused toothbrush and regular nylon bristle toothbrush in a Nigerian tertiary hospital.
Brief summary describing the background and objectives of the trial Background: Charcoal infused and regular nylon bristles toothbrushes are different options for plaque removal. Bacterial plaque is the primary aetiologic factor for periodontal diseases. Plaque control measures are essential to maintain periodontal health by preventing the accumulation of dental plaque. Aim: To compare the periodontal health and oral hygiene status of individuals using charcoal infused toothbrush and regular nylon bristle toothbrush.
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 Prevention
Anticipated trial start date 31/05/2021
Actual trial start date 31/05/2021
Anticipated date of last follow up 30/05/2022
Actual Last follow-up date 30/05/2022
Anticipated target sample size (number of participants) 25
Actual target sample size (number of participants) 22
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
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 Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group charcoal toothbrush twice daily for three weeks three weeks Charcoal infused bristle toothbrushes will be used by the participants in the experimental group for three weeks. This will be used for their regular toothbrushing and oral hygiene practice twice daily (morning and evening) for three weeks. the modified Bass technique was used by all the participants for three to four minutes at each use. After the three week duration, the periodontal and oral hygiene indices will be recorded. 11
Control Group Nylon bristle toothbrush twice daily three weeks Nylon bristle toothbrushes will be used by the participants in the control group for three weeks. This will be used for their regular toothbrushing and oral hygiene practice twice daily (morning and evening) for three weeks. the modified Bass technique was used by all the participants for three to four minutes at each use. After the three week duration, the periodontal and oral hygiene indices will be recorded. 11 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adults 18years and above. 2. Each subject having a minimum of 20 teeth with intact periodontium excluding third molars 3. Patients who are willing to participate in the study and give informed consent to do so. 1. Subjects without co morbidities. (Hypertension, Diabetes) 2. Subjects with habits and conditions that cause reduced saliva. 3. Subjects wearing orthodontic or prosthetic appliances. 4. Subjects with crowding. 5. Subjects currently on antimicrobials or analgesics. 6. Subjects who reported tobacco use in any form. 7. Subjects with mouth breathing and occlusal parafunction. 8. Subjects who are unwilling to participate in the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 31/05/2021 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Benin teaching Hospital, Ugbowo, Benin City Benin City PMB 1111 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare the periodontal health and oral hygiene status of individuals using charcoal infused tooth brush and regular nylon bristle toothbrush. after three weeks and after 6 months wash out period and three weeks from wash out period
Secondary Outcome To determine the effect of the use of charcoal infused toothbrush and regular nylon bristle toothbrush on the level of plaque control/ oral hygiene status and periodontal health in Nigerian adults. 2. To compare the level of plaque in Nigerian adults using charcoal infused toothbrush and those using regular nylon bristle toothbrush. 3. To compare the oral hygiene status of Nigerian adults using charcoal infused toothbrush and those using regular nylon bristle toothbrush 4. To compare the periodontal status of Nigerian adults using charcoal infused toothbrush and those using regular nylon bristle toothbrush After three weeks and after 6 months washout period and three weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin teaching hospital UGBOWO BENIN 300001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Veronica Obianuju Amuh Department of family Dentistry, University of Benin Teaching Hospital Benin City Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Veronica Obianuju Amuh Department of Family Dentistry, University of Benin Teaching Hospital, Benin City Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Veronica Amuh uju.momah@yahoo.com +2348033803287 Department of Family Dentistry, University of Benin Teaching Hospital
City Postal code Country Position/Affiliation
Benin City Nigeria Senior Resident
Role Name Email Phone Street address
Public Enquiries Veronica Amuh uju.momah@yahoo.com +2348033803287 Department of Family Dentistry, University of Benin Teaching Hospital
City Postal code Country Position/Affiliation
Benin City Nigeria Senior Residents
Role Name Email Phone Street address
Scientific Enquiries Veronica Amuh uju.momah@yahoo.com +2348033803287 Department of Family Dentistry, University of Benin Teaching Hospital
City Postal code Country Position/Affiliation
Benin Nigeria Senior Resident
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individua Participant Data Individual participant will be shared excluding their personal identification information Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within 24 months of completion of study controlled access, all data analysis are permitted, request will be granted to enquires from Oral health specialist and related fields.
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