Anti-Plaque and Anti-Gingivitis Effectiveness of the Newly Invented Salvadora Persica Toothbrush Compared to Salvadora Persica Chewing Stick: A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 105
- Locations
- 2
- Primary Endpoint
- Probing attachment level
Study Overview
Brief Summary
Dental plaque is a main etiologic agent in periodontal disease. Global of Burden Disease Study 2016 ranked periodontal disease as the 11th most prevalent disease affecting 10.5% population worldwide. Tooth brushing is a reliable mechanical means to control dental plaque accumulation in order to maintain oral health. For decades, studies have demonstrated the efficiency of unprocessed Salvadora persica (miswak) chewing stick practice as an alternative to a standard toothbrush. Recently, a local Malaysian company has invented and successfully mass manufactured a world-first Salvadora persica toothbrush where its nylon bristles are primarily mixed with miswak powder and natural silica. With the benefits of Salvadora persica properties intact, it is also claimed to be effective without the application of toothpaste. However, the claim remains to be fully elucidated. There is also no randomized controlled trial available evaluating the efficacy of Salvadora persica toothbrush to date. Therefore, the aim of this study is to evaluate the effectiveness of the newly invented Salvadora persica toothbrush on oral health, particularly on anti-plaque and anti-gingivitis effects. The patient related-outcomes of Salvadora persica on a short-term use will also be assessed. The hypotheses of this study are that Salvadora persica toothbrush does not contribute to the significant effects on oral health and there is no difference in the use of Salvadora persica chewing stick, Salvadora persica toothbrush as well as the standard toothbrush on anti-plaque and anti-gingivitis in a standardized manner. Additionally, a hypothesis that there is no patient-related outcome of Salvadora persica on a short-term use has also been devised. A randomized, single blind, and parallel clinical study will be conducted over a five-week period involving the healthy non-dental students of the National University of Malaysia. This study consists of three groups of different oral hygiene tools: (i) Salvadora persica toothbrush; (ii) Salvadora persica chewing stick; and (iii) Standard toothbrush and toothpaste as control. The primary outcomes of this study are the clinical parameters that will be recorded at four different appointments. Salvadora persica toothbrush is expected to show positive effects to that of standard toothbrush with respect to plaque and gingivitis control. This study is thus designed to provide an insight on Salvadora persica toothbrush as a good preventive home care therapy.
Detailed Description
The specific objectives of this clinical trial are to evaluate and compare the oral health status on gingivitis and plaque control in a standardised manner between Salvadora persica toothbrush and Salvadora persica chewing stick usage, to investigate the clinical efficiency of Salvadora persica toothbrush and Salvadora persica chewing stick on plaque removal in comparison with standard toothbrush, and to assess the patient-related outcome of Salvadora persica on a short-term use. A 20% drop out rate is to be expected.
Convenience sampling will be used in this study involving non-dental students of the National University of Malaysia Kuala Lumpur Campus. They are within the radius of the study site therefore are easy to obtain. Their manual dexterity and attitude towards oral health are the critical basis needed to maintain proper oral cleanliness, hence justified this non-probability sampling method selected.
The sample size calculation formula will be devised from a pilot study, which will primarily be conducted first involving five participants on each arm who are selected by a convenience sampling. The mean and standard deviation of two clinical parameters; Gingival Index and Plaque Index of the three groups assigned will be calculated. A confidence level of 95% with margin of error of 0.5 will be set to calculate the appropriate sample size for this study. The calculated sample size will be raised to the nearest 5 e.g. 23 will be increased to 25, to improve the validity of the study.
Prior to the participants' recruitment, the information sheet and the consent forms will be distributed. Enough time will be given for them to read and understand the study protocol before they agree to participate in this study. Those who give a consent to involve in the study will be enrolled as the participants. The principal investigator must ensure the participants understand the benefits and risks of the study. This information will be conveyed in an objective manner and any queries from the participants will be answered truthfully. The participants will have the right to refuse in participating in this study.
In this study, one principal examiner will be involved for the clinical evaluations. Prior to the initiation of the study, the examiner will be calibrated to measure the clinical parameters of periodontal attachment level, Plaque Index, and Gingival Index against another researcher who will act as a benchmark. For the assessment of intra-examiner reliability, these three clinical parameters will be recorded on five non-dental students who are not participating in this study, under the same circumstances with similar patient positioning, light positioning, and instruments. A weighted kappa score will be used to calculate the strength of agreement for both inter-examiner and intra-examiner reliability. An agreement is achieved when the values are >0.8.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
A research assistant will be responsible for randomisation and grouping hence the outcome assessor will not be aware of which group the participant belonged to. One outcome assessor will be responsible for the clinical evaluations, who will be masked to the intervention groups throughout the study. Individual participants will not be informed about the study hypothesis and will strictly be asked not to disclose to the outcome assessor which oral hygiene tool they are using. This is to ensure the outcome assossor is fully blinded in this study.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Individuals who are systemically healthy
- •Individuals who have ≥ 24 teeth
- •Individuals who have Basic Periodontal Examination score 0, 1 and 2 only with no periodontal deep pocket more than 5.5mm (gum disease)
- •Individuals who have never smoke cigarettes or other tobacco products
Exclusion Criteria
- •Individuals who are the habitual users of miswak chewing sticks, or have experienced in using them
- •Individuals who wear orthodontic appliances (braces)
- •Individuals who have grossly decayed teeth, gross overhanging restorations, severe malpositioned teeth (crowded teeth) and/or gingival recession (receding gum), have crowns placed, and wear partial dentures
- •Individuals who have current or previous history of periodontal treatment (gum treatment) including root surface debridement/periodontal surgery
- •Individuals who are poor in manual dexterity
- •Individuals who are pregnant or lactating mothers
- •Individuals who have taken antibiotics in the previous 3 months
Outcomes
Primary Outcomes
Probing attachment level
Time Frame: 5 weeks
Firstly, the periodontal pocket depth (PPD) will be assessed at six points per tooth. The measurement will be performed using a University of North Carolina probe (PCP-UNC 15) probe, which has a clear black coding of every millimetre demarcation that is up to 15 mm length. Then, probing attachment level will be assessed to the nearest millimetre by the same probe and expressed as the distance in millimetres from the cemento-enamel junction (CEJ) to the base of the pocket. This clinical assessment requires the measurement of the distance from the CEJ to the free gingival margin (FGM) for all six points. Periodontal attachment level is calculated by subtracting the distance of the CEJ to the FGM from the PPD. However, because gingival recession is an exclusion criterion in this study, gingival margin might be located at the CEJ at baseline, hence periodontal attachment level might be of similar value with to PPD.
Plaque Index
Time Frame: 5 weeks
Before the presence of dental plaque level is examined, the disclosing solution will be applied on the small cotton swab and then gently dabbed on the tooth surface. The participants will be instructed not to rinse their mouth with water until the examination is completed. Scores of 0, 1, 2 and 3 will be given. The explanation of the scores are as follows: 0 = Absence of plaque 1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface, not visible by the naked eye 2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be by the naked eye 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface
Gingival Index
Time Frame: 5 weeks
This implies the gingival status by the examination of the severity of gingival inflammation. In addition, the initiation of bleeding will be noted by gently stroking the entrance to the gingival sulcus with a blunt periodontal probe. Scores of 0, 1, 2 and 3 will be given. The explanation of the scores are as follows: 0 = Absence of plaque 1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface, not visible by the naked eye 2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface
Secondary Outcomes
- S-OHIP(M) scores(3 weeks)
- Prevalence of subjective and objective evaluation of adverse events on oral hygiene tool use(3 weeks)
Investigators
:Nurulhuda Mohd
Principal investigator; Lecturer and Clinical Consultant (Periodontist)
National University of Malaysia