Stingless Bee Honey Mouth Rinse on Gingivitis
The Development of Anti-Inflammatory and Natural-based Mouth Rinse From Stingless Bee Honey
2 other identifiers
interventional
60
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jul 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2026
CompletedFirst Posted
Study publicly available on registry
March 10, 2026
CompletedStudy Start
First participant enrolled
July 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2027
March 10, 2026
March 1, 2026
1.1 years
February 26, 2026
March 4, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
one month
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.
one month
Secondary Outcomes (1)
patient acceptance
one month
Study Arms (3)
Stingless bee honey mouth rinse
EXPERIMENTALStingless Bee Honey mouth rinse formulation that was developed for this study.
chorhexidine mouth rinse
ACTIVE COMPARATOR0.12% Chlorhexidine mouth rinse as gold standard comparison.
normal saline
PLACEBO COMPARATOR0.9% Normal saline as control.
Interventions
this is a mouth rinse with anti-inflammatory effect but also is used for cosmetic purposes to relieve bad mouth odour.
scaling is performed to remove calculus
instruction is given on performing plaque control
Eligibility Criteria
You may qualify if:
- to 60 years old patients
- BPE code 2 and/or below
- Presence of at least 20 natural teeth
You may not qualify if:
- Diabetes mellitus
- Smoking
- Mucosal lesion
- Allergic to honey
- Physical or mental disabilities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Sharma, S., Sogi, G. M., Saini, V., Chakraborty, T., & Sudan, J. (2022). Effect of liquorice (root extract) mouth rinse on dental plaque and gingivitis - A randomized controlled clinical trial. Journal of Indian Society of Periodontology, 26(1), 51-57. https://doi.org/10.4103/jisp.jisp_517_20
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Mouth rinse will be given in a sealed and coded bottle. The assignment for type of mouth rinse will be peeformed by a research assistant who does not perform the treatment and is not responsible in assessing the outcome.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2026
First Posted
March 10, 2026
Study Start
July 6, 2026
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
November 30, 2027
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share