Clinical Trial: Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Diabetic Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of the Effects of an Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Patients With Diabetes Mellitus

Brief Summary: This is a triple-blinded randomized clinical trial to evaluate the effect of an Iranian traditional mouth rinse (Punica granatum Pleniflora or "Golnaar" mouthrinse) on treatment of diabetic gingivitis and compare it with chlorhexidine (0.2%).

Detailed Summary: Among diabetic patients who refer to Motahhari clinic of Shiraz University of Medical Sciences 80 volunteers who have gingivitis and aged between 20 to 65 years old and fulfill other inclusion criteria, are randomly assigned to intervention or control groups. All of the patients will undergo a training panel about mouth hygiene and receive a pack of a toothbrush, a toothpaste, a dental floss and a mouth rinse. They are asked to return after 2 weeks for the second evaluation and taking tooth bleaching. The demographic and general information of all participants are taken and the primary outputs (plaque index and bleeding on probe) are measured at the beginning, after 2 weeks and after 4 weeks. All the examinations are done by one trained person and patients, practitioner and statistical analyser are blind to the interventions.
Sponsor: Shiraz University of Medical Sciences

Current Primary Outcome:

  • Plaque Index [ Time Frame: At the beginning, after 2 weeks and after 4 weeks ]

    0 No plaque

    1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye. But only by using disclosing solution or by using probe.
    2. Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.
    3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
  • Bleeding Index [ Time Frame: At the beginning, after 2 weeks and after 4 weeks. ]

    presence of bleeding of the gum when probing it: 0= No bleeding

    1= Bleeding occurs within 10 seconds after gentle probing of the orifice of the gingival crevice

  • Pocket Depth [ Time Frame: At the beginning, after 2 weeks and after 4 weeks ]
    It is the depth of the dental sulcus which detected by measuring the depth of sulcular insertion of the probe at six sites; mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual of all teeth divided by the teeth number. the measurement unit is millimeter (mm).
  • Modified Gingival Index [ Time Frame: At the beginning, after 2 weeks and after 4 weeks. ]

  • Plaque Index [ Time Frame: Up to 4 weeks ]
  • Bleeding Index [ Time Frame: Up to 4 weeks ]


Current Secondary Outcome:

  • Number of Participants With Adverse Events [ Time Frame: Up to 2 weeks ]
  • Satisfaction of Patients [ Time Frame: Up to 2 week ]

    We use a Visual Analogue Scale (VAS) to evaluate the patients' satisfaction and their tolerance.

    This "VAS" ranged from 1 (not satisfied at all) to 5 (fully satisfied) was used:

    1. Not satisfied at all
    2. Not satisfied adequately
    3. Not good-Not bad (So So)
    4. Mostly Satisfied
    5. Fully satisfied


Original Secondary Outcome:

  • Number of Participants With Adverse Events [ Time Frame: Up to 8 weeks ]
  • Satisfaction of Patients [ Time Frame: Up to 4 week ]
    We use a Visual Analogue Scale (VAS) to evaluate the patients' satisfaction and their tolerance.


Information By: Shiraz University of Medical Sciences

Dates:
Date Received: August 22, 2014
Date Started: July 2014
Date Completion:
Last Updated: July 13, 2016
Last Verified: July 2016