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

Not Applicable

Completed

Conditions: Gingivitis

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

Registration Number: NCT02227485

Lead Sponsor: Shiraz University of Medical Sciences

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine (0.2%)	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.
Punica granatum Pleniflora mouth rinse	Punica granatum Pleniflora (Golnaar) 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.
Chlorhexidine (0.2%)	Tooth bleaching	Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora mouth rinse	Tooth bleaching	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.

Primary Outcome Measures

Name	Time	Method
Plaque Index	At the beginning, after 2 weeks and after 4 weeks	0 No plaque 1. 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. 2. 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. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Bleeding Index	At the beginning, after 2 weeks and after 4 weeks.	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
Pocket Depth	At the beginning, after 2 weeks and after 4 weeks	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).
Modified Gingival Index	At the beginning, after 2 weeks and after 4 weeks.	0= Absence of inflammation 1. Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary 2. Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary 3. moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary 4. severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	Up to 2 weeks
Satisfaction of Patients	Up to 2 week	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: 1. Not satisfied at all 2. Not satisfied adequately 3. Not good-Not bad (So So) 4. Mostly Satisfied 5. Fully satisfied