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

Shiraz University of Medical Sciences80 enrolled

Overview

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%).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Gingivitis

Interventions

Punica granatum Pleniflora (Golnaar) mouth rinseDRUG

All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.

Chlorhexidine (0.2%)DRUG

All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.

Tooth bleachingPROCEDURE

Tooth bleaching for both groups one time after using mouth rinses.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Motahhari clinic of Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Outcomes

Primary Outcomes

Plaque Index

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.

Time frame: 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

Time frame: 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).

Time frame: At the beginning, after 2 weeks and after 4 weeks

Modified Gingival Index

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

Time frame: At the beginning, after 2 weeks and after 4 weeks.

Secondary Outcomes

Number of Participants With Adverse Events

Data from ClinicalTrials.gov

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