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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine (0.2%) | Active Comparator | Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse. |
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| Punica granatum Pleniflora mouth rinse | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Punica granatum Pleniflora (Golnaar) mouth rinse | Drug | All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Index | 0 No plaque
| 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
| At the beginning, after 2 weeks and after 4 weeks. |
| 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:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mesbah Shams, MD | Research Center for Traditional Medicine & History of Medicine - Shiraz University of Medical Sciences | Study Chair |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Motahhari clinic of Shiraz University of Medical Sciences | Shiraz | Fars | Iran |
All the records have been collected and archived, and can be reused if is necessary.
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Recruitment for Chlorhexidine group started on 11/05/2014 and ended on 07/11/2014. For Golnaar group the starting and ending dates were; 01/05/2014 and 09/11/2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks. Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Follow-up |
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| 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. |
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| Tooth bleaching | Procedure | Tooth bleaching for both groups one time after using mouth rinses. |
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| Up to 2 week |
| FG001 |
| 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. 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. Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses. |
| COMPLETED |
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| NOT COMPLETED |
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| Second Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Chlorhexidine (0.2%): All the patients in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks. Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses. |
| BG001 | 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. Punica granatum Pleniflora (Golnaar) mouth rinse: All the patients in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks. Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | The height of patients in centimeter (cm) | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Disease duration | Mean | Standard Deviation | years |
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| Teeth number | Mean | Standard Deviation | teeth |
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| BP | The maximum arterial blood pressure | Mean | Standard Deviation | mm Hg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plaque Index | 0 No plaque
| The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group. | Posted | Mean | Standard Deviation | units on a scale | At the beginning, after 2 weeks and after 4 weeks |
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| Primary | 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 | The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group. | Posted | Mean | Standard Deviation | units on a scale | At the beginning, after 2 weeks and after 4 weeks. |
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| Secondary | Number of Participants With Adverse Events | Posted | Number | participants | Up to 2 weeks |
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| Secondary | 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:
| Posted | Number | participants | Up to 2 week |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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). | The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group. | Posted | Mean | Standard Deviation | mm | At the beginning, after 2 weeks and after 4 weeks |
| |||||||||||||||||||||||||||||||||||||
| Primary | Modified Gingival Index | 0= Absence of inflammation
| The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group. | Posted | Mean | Standard Deviation | units on a scale | At the beginning, after 2 weeks and after 4 weeks. |
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During the study and up to 1 month after finishing mouth rinses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks. Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses. | 0 | 36 | 21 | 36 | ||
| EG001 | 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. 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. Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses. | 0 | 38 | 16 | 38 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unpleasant taste | Surgical and medical procedures | Non-systematic Assessment |
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| Other side effects | Surgical and medical procedures | Non-systematic Assessment |
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| Discolored | Surgical and medical procedures | Non-systematic Assessment |
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| Bad Odor | Surgical and medical procedures | Non-systematic Assessment | Bad odor of the mouth wash |
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Small sample size
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mahsa Rostami-Chijan | Shiraz University of Medical Sciences | +989111960300 | mahsa_59_2007@yahoo.com |
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D009067 | Mouthwashes |
| D002710 | Chlorhexidine |
| D035061 | Control Groups |
| D014073 | Tooth Bleaching |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D004955 | Esthetics, Dental |
| D003813 | Dentistry |
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| Male |
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| After 4 weeks |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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