GingivitisGolnaarNCT02227485

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

A study testing Punica granatum Pleniflora (Golnaar) mouth rinse, Chlorhexidine (0.2%) and Tooth bleaching in people with Gingivitis, run by Shiraz University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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%). Read more about this study

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Gingivitis
What is being tested?: Punica granatum Pleniflora (Golnaar) mouth rinse, Chlorhexidine (0.2%) and Tooth bleaching
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteIran
Study dates: Jul 2014to Dec 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Iran1 site

Motahhari clinic of Shiraz University of Medical Sciences
Shiraz, Fars

Other trials in Iran

About this study

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

Read the 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.

Conditions: Gingivitis
Being tested: Punica granatum Pleniflora (Golnaar) mouth rinse, Chlorhexidine (0.2%), Tooth bleaching
Keywords: Gingivitis, Diabetes mellitus, Medicine, Traditional, Herbal medicine, Punica granatum
Medical subject headings: Gingivitis, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Punica granatum Pleniflora (Golnaar) mouth rinseDrug
Also called Intervention group
All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.
Chlorhexidine (0.2%)Drug
Also called Control group
All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
Tooth bleachingProcedure or surgery
Also called Bleaching
Tooth bleaching for both groups one time after using mouth rinses.

Study groups in NCT02227485
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Punica granatum Pleniflora (Golnaar) mouth rinse; Procedure: Tooth bleaching

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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).
Measured: 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
Measured: At the beginning, after 2 weeks and after 4 weeks.

Secondary outcomes (2)

Number of Participants With Adverse Events
Measured: Up to 2 weeks
Satisfaction of Patients
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
Measured: Up to 2 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Dec 2014

First posted28 Aug 2014 (estimated)
Study startJul 2014
Primary completionNov 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GingivitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02227485
Sponsor's protocol ID: CT93747064
Acronym: Golnaar
Status last verified: Jul 2016
First submitted: 22 Aug 2014
Last updated: 24 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: All the records have been collected and archived, and can be reused if is necessary.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight

All Gingivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02227485
Acronym / sponsor ID: Golnaar / CT93747064
Conditions: Gingivitis
Keywords: Gingivitis, Diabetes mellitus, Medicine, Traditional, Herbal medicine, Punica granatum
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Shiraz University of Medical SciencesUniversity, hospital or other
Study start: Jul 2014
Primary completion: Nov 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 28 Aug 2014 (estimated)
Results: Posted 24 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Chlorhexidine (0.2%)	Active comparator	Drug: Chlorhexidine (0.2%), Procedure: Tooth bleachingChlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora mouth rinse	Experimental	Drug: Punica granatum Pleniflora (Golnaar) mouth rinse, Procedure: Tooth bleachingPunica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Punica granatum Pleniflora (Golnaar) mouth rinseAlso: Intervention groupAll the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.	Drug	Punica granatum Pleniflora mouth rinse
Chlorhexidine (0.2%)Also: Control groupAll the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.	Drug	Chlorhexidine (0.2%)
Tooth bleachingAlso: BleachingTooth bleaching for both groups one time after using mouth rinses.	Procedure or surgery	Chlorhexidine (0.2%), Punica granatum Pleniflora mouth rinse

Primary outcome

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.
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
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).
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

2 secondary outcomes

Number of Participants With Adverse Events
Time frame: Up to 2 weeks
Satisfaction of Patients
Time frame: Up to 2 week

Results and safety

Results posted to the registry on 24 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chlorhexidine (0.2%)	40	36
Punica Granatum Pleniflora Mouth Rinse	40	38

Primary outcome: Plaque Index

Time frame: At the beginning, after 2 weeks and after 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Chlorhexidine (0.2%) n = 40	Punica Granatum Pleniflora Mouth Rinse n = 40
At base line	2.3 (0.9)	2.5 (0.6)
After 2 weeks	1.9 (1)	2 (0.7)
After 4 weeks	0.2 (0.2)	0.2 (0.1)

Population analysed: The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.

Primary outcome: Bleeding Index

Time frame: At the beginning, after 2 weeks and after 4 weeks.. Mean (Standard Deviation). Unit: units on a scale

Measure	Chlorhexidine (0.2%) n = 40	Punica Granatum Pleniflora Mouth Rinse n = 40
At base line	0.133 (0.097)	0.148 (0.123)
After 2 weeks	0.039 (0.057)	0.034 (0.056)
After 4 weeks	0.01 (0.034)	0.016 (0.03)

Population analysed: The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.

Primary outcome: Pocket Depth

Time frame: At the beginning, after 2 weeks and after 4 weeks. Mean (Standard Deviation). Unit: mm

Measure	Chlorhexidine (0.2%) n = 40	Punica Granatum Pleniflora Mouth Rinse n = 40
At base line	1.3 (0.8)	1.6 (1.1)
After 2 weeks	0.9 (0.7)	0.8 (0.8)
After 4 weeks	0.6 (0.6)	0.6 (0.7)

Population analysed: The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.

Primary outcome: Modified Gingival Index

Time frame: At the beginning, after 2 weeks and after 4 weeks.. Mean (Standard Deviation). Unit: units on a scale

Measure	Chlorhexidine (0.2%) n = 40	Punica Granatum Pleniflora Mouth Rinse n = 40
At base line	1.3 (1)	1.3 (0.9)
After 2 weeks	0.4 (0.6)	0.2 (0.4)
After 4 weeks	0.1 (0.3)	0 (0.1)

Population analysed: The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the study and up to 1 month after finishing mouth rinses.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chlorhexidine (0.2%)	0 of 36 (0%)	21 of 36 (58.3%)	Not reported
Punica Granatum Pleniflora Mouth Rinse	0 of 38 (0%)	16 of 38 (42.1%)	Not reported

Limitations and caveats (from the sponsor): Small sample size

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. All the records have been collected and archived, and can be reused if is necessary.

Related trials for Gingivitis

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mesbah Shams, MD study chair

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

Mohammad Mahdi Fani, Dentist principal investigator

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

Massih Seddigh-Rahimabadi, MD principal investigator

Shiraz University of Medical Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Punica granatum Pleniflora (Golnaar) mouth rinse, Chlorhexidine (0.2%) and Tooth bleaching in people with Gingivitis, run by Shiraz University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plaque Index (time frame: At the beginning, after 2 weeks and after 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02227485.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2016.