Clinical trial NCT05870059: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontal Diseases
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 102
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in periodontal pocket depth.
timeFrame: baseline,6 weeks, 12 weeks.
measure: Change in clinical attachment loss.
timeFrame: baseline,6 weeks, 12 weeks
measure: change in Bleeding on probing.
timeFrame: baseline,6 weeks, 12 weeks
Secondary outcomes:
measure: Change in salivary neopterin levels.
timeFrame: baseline and 12 weeks.
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Ziauddin University
state: Sindh.
Study officials:
affiliation: Ziauddin University, shahrae ghalib, Clifton, Karachi. Pakistan.
name: Syeda M. Waqar, M.Phil
role: PRINCIPAL_INVESTIGATOR
References:
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.