N/A
Completed N=80
Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Diabetic Patients
Source: ClinicalTrials.gov NCT02227485 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcomePrimary: Plaque Index — 2.3; 2.5; 1.9; 2 units on a scale
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%).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plaque Index |
2.3; 2.5; 1.9; 2; 0.2; 0.2 | — |
| PRIMARY Bleeding Index |
0.133; 0.148; 0.039; 0.034; 0.01; 0.016 | — |
| PRIMARY Pocket Depth |
1.3; 1.6; 0.9; 0.8; 0.6; 0.6 | — |
| PRIMARY Modified Gingival Index |
1.3; 1.3; 0.4; 0.2; 0.1; 0 | — |
| SECONDARY Number of Participants With Adverse Events |
15; 22; 21; 16 | — |
| SECONDARY Satisfaction of Patients |
32; 36; 1; 0; 3; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT02227485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.