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

NCT05870059 | Completed Phase 2 DMC

• 1 other identifier: 4300921MWOM
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in salivary neopterin levels.

  baseline and 12 weeks.

Study Arms (2)

propolis

EXPERIMENTAL

5 ml of 20% propolis mouthwash twice a day.

Drug: Propolis mouthwash

chlorhexidine

ACTIVE COMPARATOR

5 ml of 0.2% chlorhexidine mouthwash twice a day.

Drug: Chlorhexidine mouthwash

Interventions

Propolis mouthwash DRUG

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.

propolis

Chlorhexidine mouthwash DRUG

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.

Also known as: clinica mouthwash

chlorhexidine

Eligibility Criteria

• Age: 40 Years - 50 Years
• Gender Eligibility Details: our participants comprises of peri-menopausal population so only the female candidates were selected.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Ziauddin University

Karachi, Sindh, Pakistan

Location

Related Publications (2)

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

  BACKGROUND

• Waqar SM, Razi A, Qureshi SS, Saher F, Zaidi SJA, Kumar C. Comparative evaluation of propolis mouthwash with 0.2% chlorhexidine mouthwash as an adjunct to mechanical therapy in improving the periodontitis among perimenopausal women: a randomized controlled trial. BMC Oral Health. 2024 Jan 5;24(1):26. doi: 10.1186/s12903-023-03768-4.

  PMID: 38183081 DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Syeda M. Waqar, M.Phil

  Ziauddin University, shahrae ghalib, Clifton, Karachi. Pakistan.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigstor

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 23, 2023
• Study Start: February 2, 2022
• Primary Completion: July 4, 2022
• Study Completion: November 16, 2022
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)