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

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Propolis mouthwash
Chlorhexidine mouthwash
Sponsored by
Ziauddin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

40 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ziauddin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

propolis

chlorhexidine

Arm Description

5 ml of 20% propolis mouthwash twice a day.

5 ml of 0.2% chlorhexidine mouthwash twice a day.

Outcomes

Primary Outcome Measures

Change in periodontal pocket depth.
Measured in mm using calibrated williams periodontal probe.
Change in clinical attachment loss.
Measured in mm using calibrated williams periodontal probe.
change in Bleeding on probing.
Presence or absence of blood in gingival pockets on probing.

Secondary Outcome Measures

Change in salivary neopterin levels.
Saliva samples were taken and stored before and after the treatment to check the levels of Neopterin through Elisa.

Full Information

First Posted
April 11, 2023
Last Updated
May 19, 2023
Sponsor
Ziauddin University
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1. Study Identification

Unique Protocol Identification Number
NCT05870059
Brief Title
Comparative Evaluation of Propolis Mouthwash With 0.2% Chlorhexidine Mouthwash in Improving the Periodontitis
Official Title
Comparative Evaluation of Propolis Mouthwash With 0.2% Chlorhexidine Mouthwash in Improving the Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
July 4, 2022 (Actual)
Study Completion Date
November 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziauddin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
propolis
Arm Type
Experimental
Arm Description
5 ml of 20% propolis mouthwash twice a day.
Arm Title
chlorhexidine
Arm Type
Active Comparator
Arm Description
5 ml of 0.2% chlorhexidine mouthwash twice a day.
Intervention Type
Drug
Intervention Name(s)
Propolis mouthwash
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine mouthwash
Other Intervention Name(s)
clinica mouthwash
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in periodontal pocket depth.
Description
Measured in mm using calibrated williams periodontal probe.
Time Frame
baseline,6 weeks, 12 weeks.
Title
Change in clinical attachment loss.
Description
Measured in mm using calibrated williams periodontal probe.
Time Frame
baseline,6 weeks, 12 weeks
Title
change in Bleeding on probing.
Description
Presence or absence of blood in gingival pockets on probing.
Time Frame
baseline,6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change in salivary neopterin levels.
Description
Saliva samples were taken and stored before and after the treatment to check the levels of Neopterin through Elisa.
Time Frame
baseline and 12 weeks.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
our participants comprises of peri-menopausal population so only the female candidates were selected.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syeda M. Waqar, M.Phil
Organizational Affiliation
Ziauddin University, shahrae ghalib, Clifton, Karachi. Pakistan.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziauddin University
City
Karachi
State/Province
Sindh.
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
Citation
Waqar SM, Huma A, Razi A, Saher F, Qureshi SS, Qureshi JA. FORMULATION DEVELOPMENT AND EVALUATION OF PROPOLIS MOUTHWASH FOR TREATMENT OF PERIODONTAL DISEASE.
Results Reference
background

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

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