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

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

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%).

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: Chlorhexidine (0.2%); Procedure: Tooth bleaching; Drug: Punica granatum Pleniflora (Golnaar) mouth rinse

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of
      • Motahhari clinic of Shiraz University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chlorhexidine (0.2%); Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.	Drug: Chlorhexidine (0.2%); All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.; Other Names: Control group; Procedure: Tooth bleaching; Tooth bleaching for both groups one time after using mouth rinses.; Other Names: Bleaching
Experimental: Punica granatum Pleniflora mouth rinse; 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.	Procedure: Tooth bleaching; Tooth bleaching for both groups one time after using mouth rinses.; Other Names: Bleaching; Drug: Punica granatum Pleniflora (Golnaar) mouth rinse; All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.; Other Names: Intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index	0 No plaque; 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.; 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.; Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.	At the beginning, after 2 weeks and after 4 weeks
Bleeding Index	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	At the beginning, after 2 weeks and after 4 weeks.
Pocket Depth	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).	At the beginning, after 2 weeks and after 4 weeks
Modified Gingival Index	0= Absence of inflammation; Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration	At the beginning, after 2 weeks and after 4 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events		Up to 2 weeks
Satisfaction of Patients	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: Not satisfied at all; Not satisfied adequately; Not good-Not bad (So So); Mostly Satisfied; Fully satisfied	Up to 2 week

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Investigators: Study Chair: Mesbah Shams, MD, Research Center for Traditional Medicine & History of Medicine - Shiraz University of Medical Sciences; Principal Investigator: Mohammad Mahdi Fani, Dentist, Research Center for Traditional Medicine & History of Medicine-Shiraz University of Medical Sciences; Principal Investigator: Massih Seddigh-Rahimabadi, MD, shiraz University of medical sciences

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: August 22, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 28, 2014

Study Record Updates

• Last Update Posted (Estimate): August 24, 2016
• Last Update Submitted That Met QC Criteria: July 13, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Diabetes mellitus; Gingivitis; Herbal medicine; Medicine, Traditional; Punica granatum
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: CT93747064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All the records have been collected and archived, and can be reused if is necessary.