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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Drug: Propolis mouthwash; Drug: Chlorhexidine mouthwash

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.

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 2

Contacts and Locations

Study Locations

• Pakistan
  • Sindh.
    • Karachi, Sindh., Pakistan
      • Ziauddin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: propolis; 5 ml of 20% propolis mouthwash twice a day.	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.
Active Comparator: chlorhexidine; 5 ml of 0.2% chlorhexidine mouthwash twice a day.	Drug: 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.; Other Names: clinica mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Ziauddin University
• Investigators: Principal Investigator: Syeda M. Waqar, M.Phil, Ziauddin University, shahrae ghalib, Clifton, Karachi. Pakistan.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): July 4, 2022
• Study Completion (Actual): November 16, 2022

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine; Propolis
• Other Study ID Numbers: 4300921MWOM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: it was written in the consent form that no information regarding patients will be shared to anyone in any case considering the ethics.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No