Gingivitis
Conditions
Keywords
Gingivitis, Diabetes mellitus, Medicine, Traditional, Herbal medicine, Punica granatum
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.
Interventions
DRUGPunica 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.
All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
PROCEDURETooth bleaching
Tooth bleaching for both groups one time after using mouth rinses.
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Iran
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Chlorhexidine (0.2%) | Punica Granatum Pleniflora Mouth Rinse | Total |
|---|---|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 6.5 | 50.35 years STANDARD_DEVIATION 6.9 | 51.33 years STANDARD_DEVIATION 6.8 |
| BP | 12.3 mm Hg STANDARD_DEVIATION 1 | 12.5 mm Hg STANDARD_DEVIATION 1.2 | 12.4 mm Hg STANDARD_DEVIATION 1.1 |
| Disease duration | 10.3 years STANDARD_DEVIATION 6.2 | 9.7 years STANDARD_DEVIATION 6.3 | 10 years STANDARD_DEVIATION 6.2 |
| Height | 163.9 cm STANDARD_DEVIATION 9.6 | 164.1 cm STANDARD_DEVIATION 10 | 164 cm STANDARD_DEVIATION 9.7 |
| Region of Enrollment Iran, Islamic Republic of | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
| Teeth number | 24.7 teeth STANDARD_DEVIATION 3.3 | 25.0 teeth STANDARD_DEVIATION 3.6 | 24.9 teeth STANDARD_DEVIATION 3.4 |
| Weight | 75.1 kg STANDARD_DEVIATION 13.5 | 75.6 kg STANDARD_DEVIATION 13.8 | 75.4 kg STANDARD_DEVIATION 13.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 36 | 16 / 38 |
| serious Total, serious adverse events | 0 / 36 | 0 / 38 |
Outcome results
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
Time frame: At the beginning, after 2 weeks and after 4 weeks.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chlorhexidine (0.2%) | Bleeding Index | At base line | 0.133 units on a scale | Standard Deviation 0.097 |
| Chlorhexidine (0.2%) | Bleeding Index | After 2 weeks | 0.039 units on a scale | Standard Deviation 0.057 |
| Chlorhexidine (0.2%) | Bleeding Index | After 4 weeks | 0.01 units on a scale | Standard Deviation 0.034 |
| Punica Granatum Pleniflora Mouth Rinse | Bleeding Index | At base line | 0.148 units on a scale | Standard Deviation 0.123 |
| Punica Granatum Pleniflora Mouth Rinse | Bleeding Index | After 2 weeks | 0.034 units on a scale | Standard Deviation 0.056 |
| Punica Granatum Pleniflora Mouth Rinse | Bleeding Index | After 4 weeks | 0.016 units on a scale | Standard Deviation 0.03 |
Primary
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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chlorhexidine (0.2%) | Modified Gingival Index | At base line | 1.3 units on a scale | Standard Deviation 1 |
| Chlorhexidine (0.2%) | Modified Gingival Index | After 2 weeks | 0.4 units on a scale | Standard Deviation 0.6 |
| Chlorhexidine (0.2%) | Modified Gingival Index | After 4 weeks | 0.1 units on a scale | Standard Deviation 0.3 |
| Punica Granatum Pleniflora Mouth Rinse | Modified Gingival Index | At base line | 1.3 units on a scale | Standard Deviation 0.9 |
| Punica Granatum Pleniflora Mouth Rinse | Modified Gingival Index | After 2 weeks | 0.2 units on a scale | Standard Deviation 0.4 |
| Punica Granatum Pleniflora Mouth Rinse | Modified Gingival Index | After 4 weeks | 0 units on a scale | Standard Deviation 0.1 |
Primary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chlorhexidine (0.2%) | Plaque Index | At base line | 2.3 units on a scale | Standard Deviation 0.9 |
| Chlorhexidine (0.2%) | Plaque Index | After 2 weeks | 1.9 units on a scale | Standard Deviation 1 |
| Chlorhexidine (0.2%) | Plaque Index | After 4 weeks | 0.2 units on a scale | Standard Deviation 0.2 |
| Punica Granatum Pleniflora Mouth Rinse | Plaque Index | At base line | 2.5 units on a scale | Standard Deviation 0.6 |
| Punica Granatum Pleniflora Mouth Rinse | Plaque Index | After 2 weeks | 2 units on a scale | Standard Deviation 0.7 |
| Punica Granatum Pleniflora Mouth Rinse | Plaque Index | After 4 weeks | 0.2 units on a scale | Standard Deviation 0.1 |
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).
Time frame: At the beginning, after 2 weeks and after 4 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chlorhexidine (0.2%) | Pocket Depth | At base line | 1.3 mm | Standard Deviation 0.8 |
| Chlorhexidine (0.2%) | Pocket Depth | After 2 weeks | 0.9 mm | Standard Deviation 0.7 |
| Chlorhexidine (0.2%) | Pocket Depth | After 4 weeks | 0.6 mm | Standard Deviation 0.6 |
| Punica Granatum Pleniflora Mouth Rinse | Pocket Depth | After 2 weeks | 0.8 mm | Standard Deviation 0.8 |
| Punica Granatum Pleniflora Mouth Rinse | Pocket Depth | At base line | 1.6 mm | Standard Deviation 1.1 |
| Punica Granatum Pleniflora Mouth Rinse | Pocket Depth | After 4 weeks | 0.6 mm | Standard Deviation 0.7 |
Secondary
Number of Participants With Adverse Events
Time frame: Up to 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chlorhexidine (0.2%) | Number of Participants With Adverse Events | No adverse event | 15 participants |
| Chlorhexidine (0.2%) | Number of Participants With Adverse Events | Had some adverse event | 21 participants |
| Punica Granatum Pleniflora Mouth Rinse | Number of Participants With Adverse Events | No adverse event | 22 participants |
| Punica Granatum Pleniflora Mouth Rinse | Number of Participants With Adverse Events | Had some adverse event | 16 participants |
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: 1. Not satisfied at all 2. Not satisfied adequately 3. Not good-Not bad (So So) 4. Mostly Satisfied 5. Fully satisfied
Time frame: Up to 2 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chlorhexidine (0.2%) | Satisfaction of Patients | So-So | 3 participants |
| Chlorhexidine (0.2%) | Satisfaction of Patients | Satisfied | 32 participants |
| Chlorhexidine (0.2%) | Satisfaction of Patients | Unsatisfied | 1 participants |
| Punica Granatum Pleniflora Mouth Rinse | Satisfaction of Patients | So-So | 2 participants |
| Punica Granatum Pleniflora Mouth Rinse | Satisfaction of Patients | Satisfied | 36 participants |
| Punica Granatum Pleniflora Mouth Rinse | Satisfaction of Patients | Unsatisfied | 0 participants |