Comparative Evaluation of Propolis Mouthwash With 0.2% Chlorhexidine Mouthwash in Improving the Periodontitis
Condition: Periodontal Diseases
MeSH terms: Periodontitis; Periodontal Diseases
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Propolis mouthwash; Chlorhexidine mouthwash
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): clinica mouthwash
Intervention MeSH terms: Chlorhexidine; Propolis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment