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

4300921MWOM

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.

2022-02-02

2022-07-04

2022-11-16

Completed

Early phase I

102

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 102, 'type': 'ACTUAL'}}

2023-05-23