Dental PlaquePhase 1NCT05258955
Title: Comparison of Anti-plaque Efficacy of Natural Honey With Chlorhexidine Mouthwash: A Randomized Controlled Trial
A Phase 1 study testing Natural honey and Chlorhexidine mouthwash in people with Dental Plaque, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
The rationale of our study is to compare the efficacy of natural honey base preparation with other commercially available mouthwashes i.e chlorhexidine base in prevention of dental plaque formation as honey is readily available and cost effective and organic in nature. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Natural honey and Chlorhexidine mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jun 2020to 21 Jan 2021
- Phase
- Phase 1
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individual aged between 18-25
- Retained 28 number of teeth excluding wisdom teeth
Who cannot join
- Individual with medical illness affecting oral cavity like diabetes, sjögren syndrome, crohn disease etc
- Multiple extraction , overhang restoration, wearing any appliance
- Periodontal problem with pocket depth more than 3mm
- Current or recent history of antibiotic consumption
- Noncompliance that is unable to maintain their hygiene.
- Pan, Betel quid and any other oral habit will not be included in study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Liaquat College of Medicine and Dentistry
Karachi, Sindh, 75800
About this study
Official title: Comparison of Anti-plaque Efficacy of Natural Honey With Chlorhexidine Mouthwash: A Randomized Controlled Trial
The rationale of our study is to compare the efficacy of natural honey base preparation with other commercially available mouthwashes i.e chlorhexidine base in prevention of dental plaque formation as honey is readily available and cost effective and organic in nature. This study will help to provide the data of our community and positive result may provide a new method of oral hygiene maintenance with fewer side effects. We will be able to deliver the best anti-plaque agent.
Read the detailed description
In this study, participants will assigned into 2 group those who will fulfilled the inclusion and exclusion criteria. After the informed consent, they were divided into 2 group. Group A will received Chlorhexidine mouthwash and Group B will provided with honey based mouthwash. The participant will blinded as solution will be provided in dark color bottle to mask the study. After which the baseline plaque index will be taken followed by recording plaque index on 7th, 14th, and 21st day. The statistical analysis will be done to compare the mean difference between these 2 groups
- Conditions
- Dental Plaque
- Being tested
- Natural honey, Chlorhexidine mouthwash
- Keywords
- Dental plaque, Honey, Chlorhexidine
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural honeyOther
Also called Sidr Honey
Natural Sidr honey based mouthwash used as intervention group B (Arm Group B) for the reduction of plaque index
Chlorhexidine mouthwashDrug
Also called Chlorhexidine Gluconate
Chlorhexidine gluconate 0.12% mouthwash is used as intervention in Group A (Arm Group A) for the comparison of plaque reduction among group A and B
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine | Active comparator | these are the group which received chlorhexidine based preparation for plaque reduction Receives: Drug: Chlorhexidine mouthwash |
| Natural honey | Experimental | these group will received the honey base mouthwash and the its effect on plaque reduction will be observed in follow up visits Receives: Other: Natural honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Plaque
primary outcome is to assessed the reduction on plaque level among Group A and Group B
Measured: reduction of plaque index will be assessed on 7th day, 14th day and on 21st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start3 Jun 2020
- Primary completion30 Dec 2020
- Study completion21 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants divided into two groups. one group will received honey based oral rinses and other group received chlorhexidine mouthwash and will evaluate the reduction of dental plaque
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Liaquat College of Medicine and Dentistry
- Responsible party
- Principal investigator, Muhammd Abid, Liaquat National Hospital & Medical College
- Investigators
- Muhammad Abid, BDS, Principal investigator, Registrar, Periodontology Liaquat College of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258955
- Sponsor's protocol ID
- 1030419MAOM
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anti-plaque Efficacy of Natural Honey With Chlorhexidine Mouthwash: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05258955
- Acronym / sponsor ID
- 1030419MAOM
- Conditions
- Dental Plaque
- Keywords
- Dental plaque, Honey, Chlorhexidine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Collaborators
- Liaquat College of Medicine and Dentistry
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 28 Feb 2022 (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.
The rationale of our study is to compare the efficacy of natural honey base preparation with other commercially available mouthwashes i.e chlorhexidine base in prevention of dental plaque formation as honey is readily available and cost effective and organic in nature. This study will help to provide the data of our community and positive result may provide a new method of oral hygiene maintenance with fewer side effects. We will be able to deliver the best anti-plaque agent.
Detailed description
In this study, participants will assigned into 2 group those who will fulfilled the inclusion and exclusion criteria. After the informed consent, they were divided into 2 group. Group A will received Chlorhexidine mouthwash and Group B will provided with honey based mouthwash. The participant will blinded as solution will be provided in dark color bottle to mask the study. After which the baseline plaque index will be taken followed by recording plaque index on 7th, 14th, and 21st day. The statistical analysis will be done to compare the mean difference between these 2 groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The participants divided into two groups. one group will received honey based oral rinses and other group received chlorhexidine mouthwash and will evaluate the reduction of dental plaque
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine | Active comparator | Drug: Chlorhexidine mouthwashthese are the group which received chlorhexidine based preparation for plaque reduction |
| Natural honey | Experimental | Other: Natural honeythese group will received the honey base mouthwash and the its effect on plaque reduction will be observed in follow up visits |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Individual aged between 18-25
- Retained 28 number of teeth excluding wisdom teeth
Key exclusion criteria (6 listed)
- Individual with medical illness affecting oral cavity like diabetes, sjögren syndrome, crohn disease etc
- Multiple extraction , overhang restoration, wearing any appliance
- Periodontal problem with pocket depth more than 3mm
- Current or recent history of antibiotic consumption
- Noncompliance that is unable to maintain their hygiene.
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 |
|---|---|---|
| Natural honeyAlso: Sidr HoneyNatural Sidr honey based mouthwash used as intervention group B (Arm Group B) for the reduction of plaque index | Other | Natural honey |
| Chlorhexidine mouthwashAlso: Chlorhexidine GluconateChlorhexidine gluconate 0.12% mouthwash is used as intervention in Group A (Arm Group A) for the comparison of plaque reduction among group A and B | Drug | Chlorhexidine |
Primary outcome
Dental Plaque
Time frame: reduction of plaque index will be assessed on 7th day, 14th day and on 21st day
primary outcome is to assessed the reduction on plaque level among Group A and Group B
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 28 Feb 2022.
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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.
Muhammad Abid, BDS principal investigator
Registrar, Periodontology Liaquat College of Medicine and Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Natural honey and Chlorhexidine mouthwash in people with Dental Plaque, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
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 2 inclusion and 6 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 28 Feb 2022. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Dental Plaque (time frame: reduction of plaque index will be assessed on 7th day, 14th day and on 21st day). 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 28 Feb 2022.