The Effect of Stingless Bee Honey Mouthrinse on Dental Plaque Accumulation
Condition: Plaque Accumulation; Patient Acceptance
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      Mouthrinses are recommended as a complement to mechanical methods in oral hygiene procedures
      to prevent and control periodontal diseases. Chlorhexidine mouthrinse has been used as a
      chemical plaque control agent for many years. However, in spite of its potent antimicrobial
      and antiplaque properties, there have been various reports of the undesirable adverse effects
      of chlorhexidine mouthrinse. This creates the need to look for an alternative mouthrinse that
      can also help in controlling plaque.

      Stingless bee honey is an alternative agent which is increasingly known for its better
      properties and easily available compared to other types of honey. It has been reported to
      have many benefits for the oral cavity such as antibacterial, anti-inflammatory, and healing
      properties which makes it a potential therapeutic agent in periodontal therapy. However,
      there is a lack of clinical studies showing its efficacy in plaque control as a mouthrinse.

      Hence, this study aims to investigate the ability of stingless bee honey mouthrinse to reduce
      plaque accumulation. This will be done through a randomised clinical trial whereby subjects
      will be prescribed with a mouthrinse formulation and instructed to refrain from any tooth
      cleaning procedure. The patient's plaque score will be recorded before and after the
      intervention to measure the effectiveness of the mouthrinse.
    

Detailed description: 
      Objectives:

      i. To investigate the patients' plaque level after use of stingless bee honey mouthrinse in a
      clinical trial. ii. To investigate patients' acceptance to stingless bee honey mouthrinse.
      iii. To compare plaque level after use of stingless bee honey mouthrinse to chlorhexidine
      mouthrinse.

      This is a randomised, double-blinded, placebo-controlled clinical study that will be
      conducted at the Faculty of Dentistry, Universiti Sains Islam Malaysia (USIM). Application of
      ethical approval will be made to USIM's medical ethical committee of the Faculty of Medicine
      and Health Science.

      Patients who seek scaling and polishing treatment at Faculty of Dentistry, USIM were invited
      to participate in study. Written and informed consent were obtained from the participants. As
      this is a pilot study, sample size calculation was not performed. A total of ten participants
      per group were recruited for the study.

      Pre-intervention, plaque score and BPE were taken at baseline by a single clinician (NAH), a
      periodontist. This was to reduce any variation in plaque score recording between different
      clinicians. Both the patients and the clinician were blinded to the intervention given to
      reduce bias. After recording the plaque score, scaling and prophylaxis were performed by
      periodontists (NAH, NHMB & MAS). This was to ensure that all participants start at an equal
      oral hygiene level and that the score taken after three days will be purely from plaque
      formation and not from the negligence of oral hygiene.

      Three different mouthrinse formulations were prepared for this study: (1) stingless bee
      honey-based mouthrinse (Bayu kelulut ®) containing honey diluted with distilled water to a
      concentration of 1:1, (2) 0.12% chlorhexidine (Oradex Antibacterial Mouthwash, Malaysia. Reg
      no: MAL06011901XCZ), and (3) placebo (negative control) containing saline solution. The
      Malaysian stingless bee honey, Bayu Kelulut ® is a product certified by Malaysian Good
      Manufacturing Practices and Malaysian Agricultural Research and Development Institute
      (MARDI), and chlorhexidine is registered under the National Pharmaceutical Regulatory Agency,
      Ministry of Health. These mouthrinse preparations were packed, sealed and coded in identical
      bottles before starting the study.

      60ml of mouthrinse in a sealed bottle were prescribed by two dental students at random. These
      formulations were mixed in Laboratory level 18, Faculty of Dentistry, Universiti Sains Islam
      Malaysia and kept in the refrigerator between 2-8°C. Patients were instructed to refrain from
      all forms of tooth cleaning and rinse 10ml of mouthrinse twice daily for two minutes. This
      was done in three days.

      After three days, the same clinician (NAH) measured the plaque score and BPE again.
      Prophylaxis were given.
    

Intervention name(s): Stingless bee honey mouthrinse; normal saline mouthrinse; chlorhexidine mouthrinse
Intervention type(s): Other; Other; Other
Intervention description(s): Three bottles of 90ml of stingless bee honey of 20% concentration was given to each subject. This mouthrinse preparation was instructed for subjects to be taken 30ml each, thrice daily for three days.; Subjects were instructed to rinse with 30ml of normal saline (0.9% concentration) thrice daily for three days.; Subjects were instructed to rinse with 30ml of chlorhexidine mouthrinse thrice daily for three days.
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomised clinical trial, blinded and performed in 3 parallel groups.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention