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.: PACTR202309483223413 Date of Approval: 15/09/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of the Use of Chewing Stick (Massularia acuminata) and Toothbrushing on Bad Breath
Official scientific title Effects of the Use of Chewing Stick (Massularia acuminata) and Toothbrushing on Volatile Sulfur Compounds Concentration and Tongue pH: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Volatile sulphur compounds are common causes of halitosis. Halitosis is a common cause of psychological distress for patients. Relieving patients’ psychological trauma experience helps to improve the quality of life of such individuals. It is also important that medical interventions are available, accessible, and affordable for clients. Mouthwashes are effective ways of reducing halitosis. They however, come at a significant cost for many Nigerians who expend huge out-of-pocket expense to access health care. Chewing sticks as an oral hygiene tool is not only cheap but also accessible, affordable, and culturally appropriate for use. If Massularia Acuminata is found to be effective in reducing the concentration of oral sulphur compounds, it can be advocated as a cost-effective and sustainable oral hygiene tool for the control of halitosis. It may also be processed for commercial use as a mouthwash. Aim: To determine the effect of Massularia Acuminata chewing stick on intra-oral VSCs concentration, tongue pH, and other clinical parameters with routine toothbrushing with fluoridated toothpaste. Primary Objectives: 1. To determine the differences in the baseline and post-intervention intra-oral VSC concentration among study participants who use toothbrush and fluoridated toothpaste in addition to Massularia Acuminata for 3 weeks. 2. To compare the baseline and post-intervention intra-oral VSC concentration in study participants who use only toothbrush and fluoridated toothpaste, and those who use toothbrush and fluoridated toothpaste in addition to Massularia Acuminata after 3 weeks. 3. To determine the differences in the baseline and post-intervention intra-oral tongue pH among study participants who use toothbrush and fluoridated toothpaste in addition to Massularia Acuminata for 3 weeks. 4. To compare the baseline and post-intervention intra-oral tongue pH in study participants who use only toothbrush and fluoridated toothpaste, and those who use toothbrush and fluoridated toothpaste in addition to Massularia Acuminata after 3 weeks.
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 Supportive care
Anticipated trial start date 08/09/2023
Actual trial start date 08/09/2023
Anticipated date of last follow up 02/02/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 86
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
5656 LAGOS UNIVERSITY TEACHING HOSPITAL HEALTH RESEARCH ETHICS COMMITTEE
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 Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Toothbrush and Toothpaste Only Pea sized toothpaste and medium textured toothbrush after breakfast in the morning, and before going to bed each for 3 minutes. Three weeks Study participants in group A will be provided with a new medium-textured manual toothbrush and a fluoridated toothpaste (TB) by the senior dental nursing officer. They will each be taught the use of the modified BASS technique for tooth brushing, including the frequency and duration of daily tooth brushing twice daily (after breakfast (TB) and before going to bed (TB) each for 3 minutes) [80]. Instructions will also be given on the quantity of toothpaste to be applied when brushing daily. 43 Active-Treatment of Control Group
Experimental Group Chewing stick Pea sized toothpaste and medium textured toothbrush after breakfast in the morning, and chewing stick before going to bed each for 3 minutes. Three weeks Study participants in group B will be given fresh Massularia acuminata as chewing sticks, a new medium-textured manual toothbrush, and a fluoridated toothpaste (CS+TB). Each study participant will also be tutored on how to brush their teeth appropriately using the modified BASS technique, the frequency and duration of daily tooth brushing (after breakfast (TB) and before going to bed (CS) each for 3 minutes). In addition, they will be taught how to prepare the working end of the chewing sticks. The sticks will be supplied weekly. Study participant will be advised to stored the chewing sticks in a fridge or in ziplock bag to preserve their freshness. 43
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants with mild to moderate gingivitis. Participants aged 18 to 29 years old. Presence of periodontitis and necrotizing oral lesions. Presence of systemic diseases such as respiratory illnesses, kidney diseases and diabetes. Pregnancy. Use of antibiotics within six weeks of study participants recruitment. Impaired manual dexterity. Use of dental prostheses such as orthodontic appliances, dentures. Tobacco smoking and use of e-cigarettes. Less than 20 teeth in the upper and lower arch. Adult: 19 Year-44 Year 18 Year(s) 29 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 26/07/2023 Lagos University Teaching Hospital Health Research Committee
Ethics Committee Address
Street address City Postal code Country
Road 1, Lagos University Teaching Hospital Lagos 100254 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Volatile sulphur compounds level Baseline, Days 7, 14 and 21
Secondary Outcome Tongue pH, Oral hygiene status, gingival health status, bleeding on probing sites, oral hygiene practices, and self-perception of halitosis. Baseline and Day 21 for Oral hygiene status, gingival health status, bleeding on probing sites, oral hygiene practices, and self-perception of halitosis. Baseline, Days 7,14 and 21 for Tongue pH
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Road 8, Lagos University Teaching Hospital Lagos 100254 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
International Association for Dental Research 1619 Duke Street, Alexandria Virginia United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Association for Dental Research 1619 Duke Street, Alexandria Virginia United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Kehinde Umeizudike Road 8, Lagos University Teaching Hospital Lagos 100254 Nigeria
Morenike Folayan Department of Paediatric Dentistry, Obafemi Awolowo University Ile Ife 220005 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adetomiwa Adedire adetomiwaadedire@gmail.com +2348165877522 Road 8, Lagos University Teaching Hospital LUTH
City Postal code Country Position/Affiliation
Ile Ife 100254 Nigeria Dentist LUTH
Role Name Email Phone Street address
Public Enquiries Dahunsi Adungbe 0olu.nonso@gmail.com +2347083423650 Road 8, LUTH
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Dentist LUTH
Role Name Email Phone Street address
Scientific Enquiries Kehinde Umeizudike kumeiz09@gmail.com +2348055451018 Road 8, LUTH
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Professor of Preventive Dentistry LUTH
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Study Protocol Beginning 3 months and ending 5 years following article publication Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose.
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