The Effect of Stingless Bee Honey Mouthrinse on Dental Plaque Accumulation

NCT06223243 | Completed

• 1 other identifier: SBH Mouthrinse
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plaque Accumulation; Patient Acceptance

Outcome Measures

Primary Outcomes (1)

• 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).

  three days

Secondary Outcomes (1)

• patients' acceptance

  3 days

Study Arms (3)

stingless bee honey

EXPERIMENTAL

stingless bee honey mouthrinse was prescribed to participants assigned to this group.

Other: Stingless bee honey mouthrinse

chlorhexidine

ACTIVE COMPARATOR

chlorhexidine mouthrinse was prescribed to participants assigned to this group.

Other: chlorhexidine mouthrinse

normal saline

PLACEBO COMPARATOR

Normal saline mouthrinse was prescribed to participants assigned to this group.

Other: normal saline mouthrinse

Interventions

Stingless bee honey mouthrinse OTHER

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.

stingless bee honey

normal saline mouthrinse OTHER

Subjects were instructed to rinse with 30ml of normal saline (0.9% concentration) thrice daily for three days.

normal saline

chlorhexidine mouthrinse OTHER

Subjects were instructed to rinse with 30ml of chlorhexidine mouthrinse thrice daily for three days.

chlorhexidine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Islam Malaysia: lead

Study Sites (1)

Students Dental Clinic, Faculty of Dentistry, University Sains Islam Malaysia.

Kuala Lumpur, Pandan Indah, 55100, Malaysia

Location

Study Officials

• NUR AYMAN ABDUL HAYEI

  FACULTY OF DENTISTRY, UNIVERSITI SAINS ISLAM MALAYSIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Tthe assessor was not involved in the mouthrinse assignment. Besides, the bottles were covered to prevent from showing the color of mouthrinse.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer

Model Details: randomised clinical trial, blinded and performed in 3 parallel groups.

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: January 25, 2024
• Study Start: March 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: January 1, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Two years

Locations

MY (1)