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NCT Number: NCT02227485

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

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%).

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Key information

Conditions

Gingivitis Diabetes Mellitus Endocrine System Diseases Gingival Diseases Glucose Metabolism Disorders Infections Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Motahhari clinic of Shiraz University of Medical Sciences

Shiraz, Fars, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Intervention group

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.

Other names: Control group

Tooth bleaching

Procedure

Tooth bleaching for both groups one time after using mouth rinses.

Other names: Bleaching

Primary outcomes

  1. Plaque Index

    Time frame: At the beginning, after 2 weeks and after 4 weeks

    0 No plaque

    • 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.
    • 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.
    • Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

  2. 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

  3. 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).

  4. Modified Gingival Index

    Time frame: At the beginning, after 2 weeks and after 4 weeks.

    0= Absence of inflammation

    • Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary
    • Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary
    • moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary
    • severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: Up to 2 weeks

  2. 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:

    • Not satisfied at all
    • Not satisfied adequately
    • Not good-Not bad (So So)
    • Mostly Satisfied
    • Fully satisfied

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

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

Acronym: Golnaar

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 28, 2014
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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