GingivitisNCT04032548
Effectiveness of Propolis Mouthwash on Gingivitis
A study testing Propolis mouthwash and Chlorhexidine mouthwash in people with Gingivitis, run by Mahsa University at 1 site in Malaysia.
Trial summary
Mouthrinses have been in used for centuries as breath fresheners, medicaments, and antiseptics. Recently, propolis has caught the eyes of dentists worldwide and researches are being carried out to infuse the usage of propolis in the dental health care treatments. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Propolis mouthwash and Chlorhexidine mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteMalaysia
- Study dates
- 18 Feb 2019to 5 Jun 2019
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gingival index >1
- Periodontal pocket depth ≤ 3 mm
- Clinical attachment loss "0"
- Provision of written informed consent
- Good systemic health.
Who cannot join
- Severe periodontal disease, as characterized by purulent exudates, generalized mobility, and/or severe recession
- Any condition that requires antibiotic premedication for the administration of a dental prophylaxis.
- Self-reported pregnancy, intent to become pregnant during the study, or breast-feeding.
- Any diseases or condition that could be expected to interfere with the safe completion of the study.
- History of antibiotic use in the previous 3 months.
- Individuals with orthodontic appliances or prosthetic appliances that would interfere with evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effectiveness of Propolis Mouthwash on Gingivitis - Randomized Controlled Clinical Study
Mouthrinses have been in used for centuries as breath fresheners, medicaments, and antiseptics. Recently, propolis has caught the eyes of dentists worldwide and researches are being carried out to infuse the usage of propolis in the dental health care treatments. There is belief that propolis may have a role as a tooth decay prophylaxis and help heal oral ulcers. Propolis is used as mouthwash, toothpaste, oral gel, and throat lozenges because of its proclaimed antibacterial and anti-inflammatory properties. Propolis has shown activity against common periodontal microorganisms, such as Candida species and the Streptococci mutans in vitro studies. Till date, no study has evaluated the clinical and microbiological effects of Malaysian Propolis as a mouthwash. Thus, the present study is designed to evaluate the effectiveness of Propolis as a mouthwash in the reduction of Plaque and gingivitis.The aim of the study is to assess and compare the effectiveness of Propolis mouthrinse with Chlorhexidine mouthrinse.
Read the detailed description
The Randomized Controlled Clinical study with latin-square cross-over design would be used to assess and compare the effectiveness of Propolis and Chlorhexidine mouthrinse on gingivitis. Subjects with chronic generalized gingivitis with age group of 18-30 years will be selected for the study as the target population. Subjects who meet the inclusion and exclusion criteria will be selected and screened for the plaque and gingival status before including them in the study. They will be randomly divided into three groups.
Group 1: 15 subjects (Placebo mouthwash) Group 2: 15 subjects (Propolis mouthwash) Group 3: 15 subjects (Chlorhexidine mouthwash)
- Conditions
- Gingivitis
- Being tested
- Placebo mouthwash, Propolis mouthwash, Chlorhexidine mouthwash
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo mouthwashDrug
Also called Mouthwash
After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).
Propolis mouthwashDrug
Also called Mouthwash
After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).
Chlorhexidine mouthwashDrug
Also called Mouthwash
After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects were asked to rinse 10 ml of mouthwash twice daily for 21 days. Receives: Drug: Placebo mouthwash |
| Propolis | Experimental | Subjects were asked to rinse 10 ml of mouthwash twice daily for 21 days. Receives: Drug: Propolis mouthwash |
| Chlorhexidine | Active comparator | Subjects were asked to rinse 10 ml of mouthwash twice daily for 21 days. Receives: Drug: Chlorhexidine mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival Index (GI)
The primary outcome variable was the differences for the mean gingival score from baseline to 21 days.
The gingival index ranges from 0-3 which is a continuous scale. '0' indicates normal healthy gingiva without inflammation (better score) ; and score '3' indicates severe gingival inflammation (worst score).
The index teeth of each participant were examined and gingival status is scored. The score for each subject is added and divided by the total number of teeth examined.
The average/mean gingival score obtained from each subject is added for all the subjects and divided by the total number of participants. Higher score indicates worst score.
Measured: Difference for the mean gingival score from baseline to 21 days.
Change in Plaque Index (PI)
The primary outcome variable was the differences for the mean plaque score from baseline to 21 days.
The plaque index ranges from 0-3 which is a continuous scale. '0' indicates no plaque on teeth (better score) ; and score '3' indicates abundance of plaque on the teeth (worst score).
The index teeth of each participant were examined and plaque score is recorded. The score for each subject is added and divided by the total number of teeth examined.
The average/mean plaque score obtained from each subject is added for all the subjects and divided by the total number of participants. Higher score indicates worst score.
Measured: Difference in the mean reduction of Plaque score from baseline to 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start18 Feb 2019
- Primary completion11 Mar 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahsa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shilpa Gunjal, Mahsa University
- Investigators
- Shilpa Gunjal, Ph.D, Principal investigator, Mahsa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032548
- Sponsor's protocol ID
- RP104-10/16
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gunjal S, Pateel DGS. Comparative effectiveness of Propolis with chlorhexidine mouthwash on gingivitis - a randomized controlled clinical study. BMC Complement Med Ther. 2024 Apr 6;24(1):154. doi: 10.1186/s12906-024-04456-8.
PubMed 38582863
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Propolis Mouthwash on Gingivitis - Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04032548
- Acronym / sponsor ID
- RP104-10/16
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mahsa UniversityUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 11 Mar 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 25 Jul 2019 (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 have been in used for centuries as breath fresheners, medicaments, and antiseptics. Recently, propolis has caught the eyes of dentists worldwide and researches are being carried out to infuse the usage of propolis in the dental health care treatments. There is belief that propolis may have a role as a tooth decay prophylaxis and help heal oral ulcers. Propolis is used as mouthwash, toothpaste, oral gel, and throat lozenges because of its proclaimed antibacterial and anti-inflammatory properties. Propolis has shown activity against common periodontal microorganisms, such as Candida species and the Streptococci mutans in vitro studies. Till date, no study has evaluated the clinical and microbiological effects of Malaysian Propolis as a mouthwash. Thus, the present study is designed to evaluate the effectiveness of Propolis as a mouthwash in the reduction of Plaque and gingivitis.The aim of the study is to assess and compare the effectiveness of Propolis mouthrinse with Chlorhexidine mouthrinse.
Detailed description
The Randomized Controlled Clinical study with latin-square cross-over design would be used to assess and compare the effectiveness of Propolis and Chlorhexidine mouthrinse on gingivitis. Subjects with chronic generalized gingivitis with age group of 18-30 years will be selected for the study as the target population. Subjects who meet the inclusion and exclusion criteria will be selected and screened for the plaque and gingival status before including them in the study. They will be randomly divided into three groups.
Group 1: 15 subjects (Placebo mouthwash) Group 2: 15 subjects (Propolis mouthwash) Group 3: 15 subjects (Chlorhexidine mouthwash)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo mouthwashSubjects were asked to rinse 10 ml of mouthwash twice daily for 21 days. |
| Propolis | Experimental | Drug: Propolis mouthwashSubjects were asked to rinse 10 ml of mouthwash twice daily for 21 days. |
| Chlorhexidine | Active comparator | Drug: Chlorhexidine mouthwashSubjects were asked to rinse 10 ml of mouthwash twice daily for 21 days. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gingival index >1
- Periodontal pocket depth ≤ 3 mm
- Clinical attachment loss "0"
- Provision of written informed consent
- Good systemic health.
Key exclusion criteria (6 listed)
- Severe periodontal disease, as characterized by purulent exudates, generalized mobility, and/or severe recession
- Any condition that requires antibiotic premedication for the administration of a dental prophylaxis.
- Self-reported pregnancy, intent to become pregnant during the study, or breast-feeding.
- Any diseases or condition that could be expected to interfere with the safe completion of the study.
- History of antibiotic use in the previous 3 months.
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 |
|---|---|---|
| Placebo mouthwashAlso: MouthwashAfter using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period). | Drug | Placebo |
| Propolis mouthwashAlso: MouthwashAfter using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period). | Drug | Propolis |
| Chlorhexidine mouthwashAlso: MouthwashAfter using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period). | Drug | Chlorhexidine |
Primary outcome
Change in Gingival Index (GI)
Time frame: Difference for the mean gingival score from baseline to 21 days.
The primary outcome variable was the differences for the mean gingival score from baseline to 21 days. The gingival index ranges from 0-3 which is a continuous scale. '0' indicates normal healthy gingiva without inflammation (better score) ; and score '3' indicates severe gingival inflammation (worst score). The index teeth of each participant were examined and gingival status is scored. The score for each subject is added and divided by the total number of teeth examined. The average/mean gingival score obtained from each subject is added for all the subjects and divided by the total number of participants. Higher score indicates worst score.
Change in Plaque Index (PI)
Time frame: Difference in the mean reduction of Plaque score from baseline to 21 days.
The primary outcome variable was the differences for the mean plaque score from baseline to 21 days. The plaque index ranges from 0-3 which is a continuous scale. '0' indicates no plaque on teeth (better score) ; and score '3' indicates abundance of plaque on the teeth (worst score). The index teeth of each participant were examined and plaque score is recorded. The score for each subject is added and divided by the total number of teeth examined. The average/mean plaque score obtained from each subject is added for all the subjects and divided by the total number of participants. Higher score indicates worst score.
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 30 Jul 2019.
- Derived from this study: PubMed 38582863Gunjal S, Pateel DGS. Comparative effectiveness of Propolis with chlorhexidine mouthwash on gingivitis - a randomized controlled clinical study. BMC Complement Med Ther. 2024 Apr 6;24(1):154. doi: 10.1186/s12906-024-04456-8.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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.
Shilpa Gunjal, Ph.D principal investigator
Mahsa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propolis mouthwash and Chlorhexidine mouthwash in people with Gingivitis, run by Mahsa University 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 5 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 30 Jul 2019. 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?
Change in Gingival Index (GI) (time frame: Difference for the mean gingival score from baseline to 21 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04032548, which also lists 1 linked publication.
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 30 Jul 2019.