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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05870059
• Other study ID #: 4300921MWOM
• Status: Completed
• Phase: Phase 2
• Start date: February 2, 2022
• Est. completion date: November 16, 2022

Study information

• Verified date: May 2023
• Source: Ziauddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 16, 2022
• Est. primary completion date: July 4, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontitis

Intervention

Drug:
• Propolis mouthwash
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 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.

Locations

Country	Name	City	State
Pakistan	Ziauddin University	Karachi	Sindh.

Sponsors (1)

Lead Sponsor	Collaborator
Ziauddin University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Waqar SM, Huma A, Razi A, Saher F, Qureshi SS, Qureshi JA. FORMULATION DEVELOPMENT AND EVALUATION OF PROPOLIS MOUTHWASH FOR TREATMENT OF PERIODONTAL DISEASE.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in periodontal pocket depth.	Measured in mm using calibrated williams periodontal probe.	baseline,6 weeks, 12 weeks.
Primary	Change in clinical attachment loss.	Measured in mm using calibrated williams periodontal probe.	baseline,6 weeks, 12 weeks
Primary	change in Bleeding on probing.	Presence or absence of blood in gingival pockets on probing.	baseline,6 weeks, 12 weeks
Secondary	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.