Evaluation of the Effects of Iranian Traditional Mouth Rinse (Golnaar) in Treatment of Gingivitis in Diabetic Patients

Gingivitis Clinical Trial

Official title: Evaluation of the Effects of Punica Granatum Plenifora (Golnaar) in Treatment of Gingivitis in Patients With Diabetes Mellitus

Status Completed

Clinical Trial Summary

This is a triple-blinded randomized clinical trial to evaluate the effect of an Iranian traditional mouth rinse (Punica granatum Plenifora or "Golnaar" mouthrinse) on treatment of diabetic gingivitis and compare it with chlorhexidine (2%).

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis

• NCT number: NCT02227485
• Study type: Interventional
• Source: Shiraz University of Medical Sciences
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Completion date: December 2014