About this trial
The currently used chemical mouth rinse, chlorhexidine, was prescribed widely among dental practitioners for its ability to kill bacteria. However, chlorhexidine prolonged use is limited due to its adverse events such as extrinsic tooth staining, taste disturbance, effects on the oral mucosa such as soreness, irritation, mild desquamation, mucosal ulceration, general burning sensation and calculus formation. Thus, an alternative natural active agent is needed to produce mouth rinse with less side effect but offer similar disease prevention effect. This comprehensive four-phase research initiative aims to advance the development and evaluation of a stingless bee honey mouth rinse, particularly focusing on improved formulation and tested in vitro and clinically. In Phase I and II, the mouth rinse development involve the improved formulation by xylitol addition in the formulation with physicochemical assessment such as shelf-life followed by antimicrobial activities against Staphylococcus aureus and cytotoxicity evaluation against oral keratinocytes. Phase III focuses on clinical trial in a pilot study that will be performed on twenty volunteers divided to two groups; control and test group who will be using mouth rinse as adjunctive periodontal therapy agent (TRL 5). Comparative analyses will assess the adjunctive effect of this stingless bee honey mouth rinse in periodontal therapy. A commercially packaged mouth rinse will be designed and produced in collaboration with Bayu Gagah Marketing and will be given to the public as free samples to obtain feedback and validate its further use in the health industry.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 to 60 years old patients
BPE code 2 and/or below
Presence of at least 20 natural teeth
Disqualifiers
Diabetes mellitus
Smoking
Mucosal lesion
Allergic to honey
Trial design
Parallel
Treatments tested in this trial
mouth rinse
Drugthis is a mouth rinse with anti-inflammatory effect but also is used for cosmetic purposes to relieve bad mouth odour.
scaling
Procedure/Surgeryscaling is performed to remove calculus
oral hygiene education and instruction
Behavioralinstruction is given on performing plaque control
Treatment groups
Trial outcomes
Primary outcomes
plaque score
Plaque score percentage will be calculated using dicotomous scale (Ainamo and Bay 1975). Presence of plaque will be assessed using periodontal probe and marked '1' while absence of plaque will be marked '0'. The total number of plaque present will be divided by the total number of sites measured and multiply with 100 to get a percentage.
bleeding score
Bleeding score will be measured using dichotomous scale (Ainamo \& Bay 1975). A periodontal probe will be used to detect bleeding on probing and '1' will be marked for its presence and '0' will be marked for its absence. The total number of bleeding present will be divided by the total number of sites assessed and multiply with 100 to get a percentage.
Secondary outcomes
patient acceptance
Patient acceptance on the mouth rinse including taste, halitosis and burning sensation will be assessed using visual analogue scale whereby the scale ranges between '0' to '10'. '0' represents the worst experience while '10' represents best experience.
Locations
Sponsors and contacts
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Ministry of Higher Education, Malaysia
Lead sponsor
Universiti Sains Islam Malaysia
Collaborator
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