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

NCT02227485 | Completed Results DMC

• 1 other identifier: CT93747064
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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%).

Conditions

Gingivitis

Keywords

Gingivitis; Diabetes mellitus; Medicine, Traditional; Herbal medicine; Punica granatum

Outcome Measures

Primary Outcomes (4)

• 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.

  At the beginning, after 2 weeks and after 4 weeks

• 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

  At the beginning, after 2 weeks and after 4 weeks.

• 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).

  At the beginning, after 2 weeks and after 4 weeks

• 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

  At the beginning, after 2 weeks and after 4 weeks.

Secondary Outcomes (2)

• Number of Participants With Adverse Events

  Up to 2 weeks

• Satisfaction of Patients

  Up to 2 week

Study Arms (2)

Chlorhexidine (0.2%)

ACTIVE COMPARATOR

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%); Procedure: Tooth bleaching

Punica granatum Pleniflora mouth rinse

EXPERIMENTAL

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.

Drug: Punica granatum Pleniflora (Golnaar) mouth rinse; Procedure: Tooth bleaching

Interventions

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.

Also known as: Intervention group

Punica granatum Pleniflora mouth rinse

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.

Also known as: Control group

Chlorhexidine (0.2%)

Tooth bleaching PROCEDURE

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

Also known as: Bleaching

Chlorhexidine (0.2%); Punica granatum Pleniflora mouth rinse

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Motahhari clinic of Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Gingivitis; Diabetes Mellitus

Interventions

Mouthwashes; Chlorhexidine; Control Groups; Tooth Bleaching

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture; Biguanides; Guanidines; Amidines; Organic Chemicals; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Esthetics, Dental; Dentistry

Limitations and Caveats

Small sample size

Results Point of Contact

• Title: Dr. Mahsa Rostami-Chijan
• Organization: Shiraz University of Medical Sciences

mahsa_59_2007@yahoo.com

+989111960300

Study Officials

• Mesbah Shams, MD

  Research Center for Traditional Medicine & History of Medicine - Shiraz University of Medical Sciences

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Internal Medicine & Endocrinology

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 28, 2014
• Study Start: July 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 24, 2016
• Results First Posted: August 24, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

IR (1)