Stingless Bee Honey Mouth Rinse on Gingivitis

ConditionGingivitis
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMinistry of Higher Education, Malaysia

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • mouth rinse

    Drug

    this is a mouth rinse with anti-inflammatory effect but also is used for cosmetic purposes to relieve bad mouth odour.

  • scaling

    Procedure/Surgery

    scaling is performed to remove calculus

  • oral hygiene education and instruction

    Behavioral

    instruction is given on performing plaque control

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Stingless bee honey mouth rinseExperimental treatment 3 interventions
Group B: chorhexidine mouth rinseActive comparator 3 interventions
Group C: normal salinePlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
one month
2

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.

Time frame
one month

Secondary outcomes

1

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.

Time frame
one month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Ministry of Higher Education, Malaysia

Lead sponsor

Universiti Sains Islam Malaysia

Collaborator

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