Comparative Evaluation of Propolis Mouthwash With 0.2% Chlorhexidine

Status Completed

Clinical 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. 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.

Clinical Trial 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. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05870059
Study type	Interventional
Source	Ziauddin University
Contact
Status	Completed
Phase	Phase 2
Start date	February 2, 2022
Completion date	November 16, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparative Evaluation of Propolis Mouthwash With 0.2% Chlorhexidine Mouthwash in Improving the Periodontitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms