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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:
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.
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.
a) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propolis | Experimental | 5 ml of 20% propolis mouthwash twice a day. |
|
| chlorhexidine | Active Comparator | 5 ml of 0.2% chlorhexidine mouthwash twice a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propolis mouthwash | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in periodontal pocket depth. | Measured in mm using calibrated williams periodontal probe. | baseline,6 weeks, 12 weeks. |
| Change in clinical attachment loss. | Measured in mm using calibrated williams periodontal probe. | baseline,6 weeks, 12 weeks |
| change in Bleeding on probing. | Presence or absence of blood in gingival pockets on probing. | baseline,6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in salivary neopterin levels. | Saliva samples were taken and stored before and after the treatment to check the levels of Neopterin through Elisa. | baseline and 12 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
our participants comprises of peri-menopausal population so only the female candidates were selected.
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| Name | Affiliation | Role |
|---|---|---|
| Syeda M. Waqar, M.Phil | Ziauddin University, shahrae ghalib, Clifton, Karachi. Pakistan. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziauddin University | Karachi | Sindh | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Waqar SM, Huma A, Razi A, Saher F, Qureshi SS, Qureshi JA. FORMULATION DEVELOPMENT AND EVALUATION OF PROPOLIS MOUTHWASH FOR TREATMENT OF PERIODONTAL DISEASE. | ||
| 38183081 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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As this is going to be a double-blind study, a third person will dispense the Propolis mouthwash (prepared in Ziauddin College of pharmacy) and Chlorhexidine mouthwash (commercially available) into dark-colored bottles of the same size and shape. The third person will code the bottles as A or B and seal the codes with the product name in envelopes accordingly.
| Chlorhexidine mouthwash | Drug | 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. |
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