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

July 13, 2016 updated by: Mesbah Shams, MD, Shiraz University of Medical Sciences

Evaluation of the Effects of an Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Patients With Diabetes Mellitus

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%).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Fars
      • Shiraz, Fars, Iran, Islamic Republic of
        • Motahhari clinic of Shiraz University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: Chlorhexidine (0.2%)
All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
Other Names:
  • Control group
Procedure: Tooth bleaching
Tooth bleaching for both groups one time after using mouth rinses.
Other Names:
  • Bleaching
Experimental: 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.
Procedure: Tooth bleaching
Tooth bleaching for both groups one time after using mouth rinses.
Other Names:
  • Bleaching
Drug: 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.
Other Names:
  • Intervention group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: 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.
At the beginning, after 2 weeks and after 4 weeks
Bleeding Index
Time Frame: 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
At the beginning, after 2 weeks and after 4 weeks.
Pocket Depth
Time Frame: 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).
At the beginning, after 2 weeks and after 4 weeks
Modified Gingival Index
Time Frame: 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
At the beginning, after 2 weeks and after 4 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: Up to 2 weeks
Up to 2 weeks
Satisfaction of Patients
Time Frame: 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
Up to 2 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shiraz University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mesbah Shams, MD, Research Center for Traditional Medicine & History of Medicine - Shiraz University of Medical Sciences
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT93747064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All the records have been collected and archived, and can be reused if is necessary.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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