Clinical trial NCT02227485: Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Diabetic Patients
Official title: Evaluation of the Effects of an Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Keywords: Gingivitis
Diabetes mellitus
Medicine, Traditional
Herbal medicine
Punica granatum
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-08-28
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Plaque Index
timeFrame: At the beginning, after 2 weeks and after 4 weeks
measure: Bleeding Index
timeFrame: At the beginning, after 2 weeks and after 4 weeks.
measure: Pocket Depth
timeFrame: At the beginning, after 2 weeks and after 4 weeks
measure: Modified Gingival Index
timeFrame: At the beginning, after 2 weeks and after 4 weeks.
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to 2 weeks
measure: Satisfaction of Patients
timeFrame: Up to 2 week
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Motahhari clinic of Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Research Center for Traditional Medicine & History of Medicine - Shiraz University of Medical Sciences
name: Mesbah Shams, MD
role: STUDY_CHAIR
affiliation: Research Center for Traditional Medicine & History of Medicine-Shiraz University of Medical Sciences
name: Mohammad Mahdi Fani, Dentist
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Massih Seddigh-Rahimabadi, MD
role: PRINCIPAL_INVESTIGATOR
References: