Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06223243 |
| Other study ID # |
SBH Mouthrinse |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2023 |
| Est. completion date |
January 1, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Universiti Sains Islam Malaysia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
