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

Shiraz University of Medical Sciences

Status: Completed

Conditions: Gingivitis

Treatments: Procedure: Tooth bleaching; Drug: Chlorhexidine (0.2%); Drug: Punica granatum Pleniflora (Golnaar) mouth rinse

Study type: Interventional

Funder types: Other

Identifiers

NCT02227485

CT93747064

Details and patient eligibility

About

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%).

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• To have gingivitis
• Controlled diabetes mellitus [FBS<130mg/dl & Glycosilated hemoglobin (A1C)<7%]
• Presence of gingivitis
• Having at least 20 teeth
• No history of hypersensitivity reaction
• Age between 20 to 65 years
• Agreement to participate in the study

Exclusion criteria

• History of hypersensitivity reaction
• Smoking
• Systemic diseases (Kidney, liver or rheumatologic diseases)
• To have a pocket depth of more than 5
• Consumption of antibiotics, corticosteroids or nonsteroidal anti-inflammatory drugs in the past 3 months and during the study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Chlorhexidine (0.2%)

Active Comparator group

Description:

Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.

Treatment:

Procedure: Tooth bleaching

Drug: Chlorhexidine (0.2%)

Punica granatum Pleniflora mouth rinse

Experimental group

Description:

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.

Treatment:

Drug: Punica granatum Pleniflora (Golnaar) mouth rinse

Procedure: Tooth bleaching