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

Study Overview
=================
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.

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

Conditions
-----------------
Gingivitis

Intervention / Treatment
-----------------
* Drug: Punica granatum Pleniflora (Golnaar) mouth rinse
* Drug: Chlorhexidine (0.2%)
* Procedure: Tooth bleaching


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gingivitis, Diabetes mellitus, Medicine, Traditional, Herbal medicine, Punica granatum