Conditions: Gingivitis
Keywords: Gingivitis Diabetes mellitus Medicine, Traditional Herbal medicine Punica granatum
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: no

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 description:
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.

Arms:
arm 1: Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse. arm 2: Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.

Interventions: intervention 1: Punica granatum Pleniflora (Golnaar) mouth rinse intervention 2: Chlorhexidine (0.2%) intervention 3: Tooth bleaching
Intervention descriptions: intervention 1: All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks. intervention 2: All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks. intervention 3: Tooth bleaching for both groups one time after using mouth rinses.

Protocol document: