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NOT YET RECRUITING
NCT07461155
EARLY_PHASE1

Stingless Bee Honey Mouth Rinse on Gingivitis

Sponsor: Ministry of Higher Education, Malaysia

View on ClinicalTrials.gov

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.

Official title: The Development of Anti-Inflammatory and Natural-based Mouth Rinse From Stingless Bee Honey

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-07-06

Completion Date

2027-11-30

Last Updated

2026-03-10

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

mouth rinse

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

PROCEDURE

scaling

scaling is performed to remove calculus

BEHAVIORAL

oral hygiene education and instruction

instruction is given on performing plaque control