Plaque AccumulationNCT06223243
The Effect of Stingless Bee Honey Mouthrinse on Dental Plaque Accumulation
A study testing Stingless bee honey mouthrinse, normal saline mouthrinse and chlorhexidine mouthrinse in people with Plaque Accumulation and Patient Acceptance, run by Universiti Sains Islam Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Accumulation, Patient Acceptance
- What is being tested?
- Stingless bee honey mouthrinse, normal saline mouthrinse and chlorhexidine mouthrinse
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically healthy participants aged between 18-40
- Healthy gingiva or localised gingivitis with the highest Basic Periodontal Examination (BPE) score of 2
- Presence of at least 20 natural teeth
Who cannot join
- Diabetes
- Physical and/or mental disabilities that may interfere with receiving mouthrinse instructions
- Orthodontic or prosthodontic appliances
- Undergoing antibiotic/antimicrobial therapy
- Current smoker
- Abnormal saliva secretion rate
- Pregnancy
- Allergy to honey or bee stings
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Students Dental Clinic, Faculty of Dentistry, University Sains Islam Malaysia.
Kuala Lumpur, Pandan Indah, 55100
About this study
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.
Read the detailed description
Objectives:
- 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.
- Conditions
- Plaque Accumulation, Patient Acceptance
- Being tested
- Stingless bee honey mouthrinse, normal saline mouthrinse, chlorhexidine mouthrinse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stingless bee honey mouthrinseOther
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.
normal saline mouthrinseOther
Subjects were instructed to rinse with 30ml of normal saline (0.9% concentration) thrice daily for three days.
chlorhexidine mouthrinseOther
Subjects were instructed to rinse with 30ml of chlorhexidine mouthrinse thrice daily for three days.
| Study group | Role | What they receive |
|---|---|---|
| stingless bee honey | Experimental | stingless bee honey mouthrinse was prescribed to participants assigned to this group. Receives: Other: Stingless bee honey mouthrinse |
| chlorhexidine | Active comparator | chlorhexidine mouthrinse was prescribed to participants assigned to this group. Receives: Other: chlorhexidine mouthrinse |
| normal saline | Placebo comparator | Normal saline mouthrinse was prescribed to participants assigned to this group. Receives: Other: normal saline mouthrinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
plaque score
plaque accumulation level will be measured using dichotomous scoring system ( 1- presence of plaque and 0- absence of plaque) for each 4 sites in each tooth. The scoring will be added and divided by total number of sites, and results in a percentage (plaque score).
Measured: three days
Secondary outcomes (1)
patients' acceptance
patients' acceptance on mouthrinse in terms of halitosis, taste, odour and burning sensation were recorded using visual analogue scale whereby 1 indicates worst experience while 10 indicates best experience.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Mar 2023
- Primary completion1 Sep 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque AccumulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised clinical trial, blinded and performed in 3 parallel groups.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Islam Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NUR AYMAN ABDUL HAYEI, Universiti Sains Islam Malaysia
- Investigators
- NUR AYMAN ABDUL HAYEI, Principal investigator, FACULTY OF DENTISTRY, UNIVERSITI SAINS ISLAM MALAYSIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223243
- Sponsor's protocol ID
- SBH Mouthrinse
- Status last verified
- Jan 2024
- First submitted
- 16 Feb 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD might be shared if it would expand the results of the study.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stingless Bee Honey Mouthrinse on Dental Plaque Accumulation
- ClinicalTrials.gov ID
- NCT06223243
- Acronym / sponsor ID
- SBH Mouthrinse
- Conditions
- Plaque Accumulation, Patient Acceptance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universiti Sains Islam MalaysiaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomised clinical trial, blinded and performed in 3 parallel groups.
| Arm | Type | Receives |
|---|---|---|
| stingless bee honey | Experimental | Other: Stingless bee honey mouthrinsestingless bee honey mouthrinse was prescribed to participants assigned to this group. |
| chlorhexidine | Active comparator | Other: chlorhexidine mouthrinsechlorhexidine mouthrinse was prescribed to participants assigned to this group. |
| normal saline | Placebo comparator | Other: normal saline mouthrinseNormal saline mouthrinse was prescribed to participants assigned to this group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Medically healthy participants aged between 18-40
- Healthy gingiva or localised gingivitis with the highest Basic Periodontal Examination (BPE) score of 2
- Presence of at least 20 natural teeth
Key exclusion criteria (8 listed)
- Diabetes
- Physical and/or mental disabilities that may interfere with receiving mouthrinse instructions
- Orthodontic or prosthodontic appliances
- Undergoing antibiotic/antimicrobial therapy
- Current smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stingless bee honey mouthrinseThree 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. | Other | stingless bee honey |
| normal saline mouthrinseSubjects were instructed to rinse with 30ml of normal saline (0.9% concentration) thrice daily for three days. | Other | normal saline |
| chlorhexidine mouthrinseSubjects were instructed to rinse with 30ml of chlorhexidine mouthrinse thrice daily for three days. | Other | chlorhexidine |
Primary outcome
plaque score
Time frame: three days
plaque accumulation level will be measured using dichotomous scoring system ( 1- presence of plaque and 0- absence of plaque) for each 4 sites in each tooth. The scoring will be added and divided by total number of sites, and results in a percentage (plaque score).
1 secondary outcome
patients' acceptance
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: Yes. The IPD might be shared if it would expand the results of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NUR AYMAN ABDUL HAYEI principal investigator
FACULTY OF DENTISTRY, UNIVERSITI SAINS ISLAM MALAYSIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stingless bee honey mouthrinse, normal saline mouthrinse and chlorhexidine mouthrinse in people with Plaque Accumulation and Patient Acceptance, run by Universiti Sains Islam Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plaque score (time frame: three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.