Periodontal DiseasesPhase 2NCT05870059
Comparative Evaluation of Propolis Mouthwash With 0.2% Chlorhexidine Mouthwash in Improving the Periodontitis
A Phase 2 study testing Propolis mouthwash and Chlorhexidine mouthwash in people with Periodontal Diseases, run by Ziauddin University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare the efficacy of Propolis mouthwash with 0.2% Chlorhexidine mouthwash as an adjunct to mechanical therapy in improving the status of periodontal disease in peri-menopausal women. Read more about this study
- Who is it for?
- Ages 40 to 50 years, women only
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Propolis mouthwash and Chlorhexidine mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Feb 2022to 16 Nov 2022
- Phase
- Phase 2
- 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 40 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females of age 40-50 years.
- Patients who are willing to receive treatment and give informed consent.
- Patients with probing pocket depth (PPD) of 4mm - 5mm and clinical attachment loss (CAL) of 1-4 mm.
- Presence of bleeding on probing (BOP).
- Patients should not have been subject to periodontal therapy and antibiotic medication in the past 6 months.
- Patients with a minimum of 20 teeth in the oral cavity.
Who cannot join
- Patients who are allergic to honey products.
- Patients on HRT (hormone replacement therapy) or patients who have not had a menstrual cycle for the last 12 months.
- Patients who had lost teeth because of periodontal disease.
- Patients who are or have been smokers in the past.
- Patients are on any kind of antibiotic therapy at the time of screening.
- Systemic conditions predispose patients to chronic periodontal diseases such as diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to compare the efficacy of Propolis mouthwash with 0.2% Chlorhexidine mouthwash as an adjunct to mechanical therapy in improving the status of periodontal disease in peri-menopausal women.
The main question it aims to answer are:
Read more
- Will propolis mouthwash be equal to Chlorhexidine mouthwash in improving the periodontal status of perimenopausal women?
- Can neopterin be used as an indicator of periodontal disease.
Participants will be asked questions about their general health, menstrual health and oral health then scaling will be done. After that participants will give saliva sample by spitting in a given container. Participants will be divided into 2 groups for treatment and each group comprised of 51 participants.
Group 1: 20% Propolis mouthwash, twice a day for 6 weeks. Group 2: 0.2% chlorhexidine mouthwash, twice a day for 6 weeks.
Read the detailed description
Patients who gave consent underwent oral examination and subjects with scores 3 and 4 according to the protocols described by the British Society of Periodontology were recruited into the study.
To evaluate the treatment outcome following periodontal parameters were assessed at baseline, 6 weeks and 12 weeks.
- periodontal pocket depth b) clinical attachment loss c) bleeding on probing.
The development of mouthwash includes 2 steps i.e. extraction and formulation. i) Propolis extraction was carried out at the University of Karachi, and the propolis collected was authenticated by the Department of Pharmacognosy, Faculty of Pharmacy, University of Karachi.
ii) The formulation was done by the Department of Pharmacognosy at Ziauddin College of Pharmacology.
After formulations, various stability tests were performed on mouthwash to check its safety such as pH, Viscosity, Bio-burden and skin irritancy test. In the end, participants were also asked questions to check the acceptability of the product in terms of odour, colour, taste, fragrance, application and satisfaction with the outcome by the participants. those items that achieved acceptance of 80% or above were considered acceptable.
Saliva samples were taken at baseline and 12 weeks and neopterin levels were assessed using ELISA.
The correlation between neopterin levels and measures of clinical parameters after the treatment is made to evaluate if neopterin can be used as an indicator of disease progression and treatment outcome.
- Conditions
- Periodontal Diseases
- Being tested
- Propolis mouthwash, Chlorhexidine mouthwash
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propolis mouthwashDrug
After scaling and root planning at the baseline visit, patients were prescribed to use 5ml of propolis mouthwash twice a day for 6 weeks. patients were also prescribed to not eat and drink anything for half an hour after the rinse.
Chlorhexidine mouthwashDrug
Also called clinica mouthwash
After scaling and root planning at the baseline visit, patients were prescribed to use chlorhexidine mouthwash twice a day for 6 weeks. patients were also prescribed to not eat and drink anything for half an hour after the rinse.
| Study group | Role | What they receive |
|---|---|---|
| propolis | Experimental | 5 ml of 20% propolis mouthwash twice a day. Receives: Drug: Propolis mouthwash |
| chlorhexidine | Active comparator | 5 ml of 0.2% chlorhexidine mouthwash twice a day. Receives: Drug: Chlorhexidine mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in periodontal pocket depth.
Measured in mm using calibrated williams periodontal probe.
Measured: baseline,6 weeks, 12 weeks.
Change in clinical attachment loss.
Measured in mm using calibrated williams periodontal probe.
Measured: baseline,6 weeks, 12 weeks
change in Bleeding on probing.
Presence or absence of blood in gingival pockets on probing.
Measured: baseline,6 weeks, 12 weeks
Secondary outcomes (1)
Change in salivary neopterin levels.
Saliva samples were taken and stored before and after the treatment to check the levels of Neopterin through Elisa.
Measured: baseline and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start2 Feb 2022
- Primary completion4 Jul 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Maliha Waqar, Ziauddin University
- Investigators
- Syeda M. Waqar, M.Phil, Principal investigator, Ziauddin University, shahrae ghalib, Clifton, Karachi. Pakistan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870059
- Sponsor's protocol ID
- 4300921MWOM
- Status last verified
- May 2023
- First submitted
- 11 Apr 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it was written in the consent form that no information regarding patients will be shared to anyone in any case considering the ethics.
Publications
Waqar SM, Huma A, Razi A, Saher F, Qureshi SS, Qureshi JA. FORMULATION DEVELOPMENT AND EVALUATION OF PROPOLIS MOUTHWASH FOR TREATMENT OF PERIODONTAL DISEASE.
Waqar SM, Razi A, Qureshi SS, Saher F, Zaidi SJA, Kumar C. Comparative evaluation of propolis mouthwash with 0.2% chlorhexidine mouthwash as an adjunct to mechanical therapy in improving the periodontitis among perimenopausal women: a randomized controlled trial. BMC Oral Health. 2024 Jan 5;24(1):26. doi: 10.1186/s12903-023-03768-4.
PubMed 38183081
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Propolis Mouthwash With 0.2% Chlorhexidine Mouthwash in Improving the Periodontitis
- ClinicalTrials.gov ID
- NCT05870059
- Acronym / sponsor ID
- 4300921MWOM
- Conditions
- Periodontal Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 23 May 2023 (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 goal of this clinical trial is to compare the efficacy of Propolis mouthwash with 0.2% Chlorhexidine mouthwash as an adjunct to mechanical therapy in improving the status of periodontal disease in peri-menopausal women.
The main question it aims to answer are:
- Will propolis mouthwash be equal to Chlorhexidine mouthwash in improving the periodontal status of perimenopausal women?
- Can neopterin be used as an indicator of periodontal disease.
Participants will be asked questions about their general health, menstrual health and oral health then scaling will be done. After that participants will give saliva sample by spitting in a given container. Participants will be divided into 2 groups for treatment and each group comprised of 51 participants.
Group 1: 20% Propolis mouthwash, twice a day for 6 weeks. Group 2: 0.2% chlorhexidine mouthwash, twice a day for 6 weeks.
Detailed description
Patients who gave consent underwent oral examination and subjects with scores 3 and 4 according to the protocols described by the British Society of Periodontology were recruited into the study.
To evaluate the treatment outcome following periodontal parameters were assessed at baseline, 6 weeks and 12 weeks.
- periodontal pocket depth b) clinical attachment loss c) bleeding on probing.
The development of mouthwash includes 2 steps i.e. extraction and formulation. i) Propolis extraction was carried out at the University of Karachi, and the propolis collected was authenticated by the Department of Pharmacognosy, Faculty of Pharmacy, University of Karachi.
ii) The formulation was done by the Department of Pharmacognosy at Ziauddin College of Pharmacology.
After formulations, various stability tests were performed on mouthwash to check its safety such as pH, Viscosity, Bio-burden and skin irritancy test. In the end, participants were also asked questions to check the acceptability of the product in terms of odour, colour, taste, fragrance, application and satisfaction with the outcome by the participants. those items that achieved acceptance of 80% or above were considered acceptable.
Saliva samples were taken at baseline and 12 weeks and neopterin levels were assessed using ELISA.
The correlation between neopterin levels and measures of clinical parameters after the treatment is made to evaluate if neopterin can be used as an indicator of disease progression and treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propolis | Experimental | Drug: Propolis mouthwash5 ml of 20% propolis mouthwash twice a day. |
| chlorhexidine | Active comparator | Drug: Chlorhexidine mouthwash5 ml of 0.2% chlorhexidine mouthwash twice a day. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Females of age 40-50 years.
- Patients who are willing to receive treatment and give informed consent.
- Patients with probing pocket depth (PPD) of 4mm - 5mm and clinical attachment loss (CAL) of 1-4 mm.
- Presence of bleeding on probing (BOP).
- Patients should not have been subject to periodontal therapy and antibiotic medication in the past 6 months.
Key exclusion criteria (6 listed)
- Patients who are allergic to honey products.
- Patients on HRT (hormone replacement therapy) or patients who have not had a menstrual cycle for the last 12 months.
- Patients who had lost teeth because of periodontal disease.
- Patients who are or have been smokers in the past.
- Patients are on any kind of antibiotic therapy at the time of screening.
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 |
|---|---|---|
| Propolis mouthwashAfter scaling and root planning at the baseline visit, patients were prescribed to use 5ml of propolis mouthwash twice a day for 6 weeks. patients were also prescribed to not eat and drink anything for half an hour after the rinse. | Drug | propolis |
| Chlorhexidine mouthwashAlso: clinica mouthwashAfter scaling and root planning at the baseline visit, patients were prescribed to use chlorhexidine mouthwash twice a day for 6 weeks. patients were also prescribed to not eat and drink anything for half an hour after the rinse. | Drug | chlorhexidine |
Primary outcome
Change in periodontal pocket depth.
Time frame: baseline,6 weeks, 12 weeks.
Measured in mm using calibrated williams periodontal probe.
Change in clinical attachment loss.
Time frame: baseline,6 weeks, 12 weeks
Measured in mm using calibrated williams periodontal probe.
change in Bleeding on probing.
Time frame: baseline,6 weeks, 12 weeks
Presence or absence of blood in gingival pockets on probing.
1 secondary outcome
Change in salivary neopterin levels.
Time frame: baseline and 12 weeks.
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 23 May 2023.
- BackgroundWaqar SM, Huma A, Razi A, Saher F, Qureshi SS, Qureshi JA. FORMULATION DEVELOPMENT AND EVALUATION OF PROPOLIS MOUTHWASH FOR TREATMENT OF PERIODONTAL DISEASE.
- Derived from this study: PubMed 38183081Waqar SM, Razi A, Qureshi SS, Saher F, Zaidi SJA, Kumar C. Comparative evaluation of propolis mouthwash with 0.2% chlorhexidine mouthwash as an adjunct to mechanical therapy in improving the periodontitis among perimenopausal women: a randomized controlled trial. BMC Oral Health. 2024 Jan 5;24(1):26. doi: 10.1186/s12903-023-03768-4.
- Individual participant dataSharing planned: No. it was written in the consent form that no information regarding patients will be shared to anyone in any case considering the ethics.
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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.
Syeda M. Waqar, M.Phil principal investigator
Ziauddin University, shahrae ghalib, Clifton, Karachi. Pakistan.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propolis mouthwash and Chlorhexidine mouthwash in people with Periodontal Diseases, run by Ziauddin University 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 6 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 23 May 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in periodontal pocket depth. (time frame: baseline,6 weeks, 12 weeks.). The study lists 3 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 NCT05870059, which also lists 2 linked publications.
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 23 May 2023.