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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227485
• Other study ID #: CT93747064
• Status: Completed
• Phase: N/A
• First received: August 22, 2014
• Last updated: December 1, 2014
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

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%).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Controlled diabetes mellitus (FBS<130mg/dl & 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)

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

Intervention

Drug:
• Punica granatum Plenifora (Golnaar) mouth rinse
All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.
• Chlorhexidine (2%)
All the patient in control group use 10 ml of chlorhexidine (2%) for 2 minutes every night for 2 weeks.

Procedure:
• Tooth bleaching
Tooth bleaching for both groups one time afterusing mouth rinses.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Motahhari clinic of Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque index		Up to 4 weeks	No
Primary	Bleeding Index		Up to 4 weeks	No
Secondary	Number of participants with adverse events		Up to 8 weeks	Yes
Secondary	Satisfaction of patients	We use a Visual Analogue Scale (VAS) to evaluate the patients' satisfaction and their tolerance.	Up to 4 week	Yes