Trial · NCT02227485

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

NCT02227485, Not applicable, Completed, Shiraz University of Medical Sciences; results first posted 2016-08-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Diabetic Patients. Trials, record NCT02227485. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02227485

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Diabetic Patients
NCT number: NCT02227485
Status: Completed
Phases: Not applicable
Enrollment: 80 participants, actual
Lead sponsor: Shiraz University of Medical Sciences
Conditions: Gingivitis
Interventions: Punica granatum Pleniflora (Golnaar) mouth rinse, Chlorhexidine (0.2%), Tooth bleaching
First posted: 2014-08-28
Last updated: 2016-08-24
Results first posted: 2016-08-24
Limitations and caveats: Small sample size

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Plaque Index	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.
Primary	Bleeding Index	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
Primary	Pocket Depth	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).
Primary	Modified Gingival Index	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
Secondary	Number of Participants With Adverse Events	Up to 2 weeks
Secondary	Satisfaction of Patients	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

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Plaque Index	At the beginning, after 2 weeks and after 4 weeks	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.	units on a scale	MEAN
PRIMARY	Bleeding Index	At the beginning, after 2 weeks and after 4 weeks.	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.	units on a scale	MEAN
SECONDARY	Number of Participants With Adverse Events	Up to 2 weeks		participants	NUMBER
SECONDARY	Satisfaction of Patients	Up to 2 week		participants	NUMBER
PRIMARY	Pocket Depth	At the beginning, after 2 weeks and after 4 weeks	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.	mm	MEAN
PRIMARY	Modified Gingival Index	At the beginning, after 2 weeks and after 4 weeks.	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.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Plaque Index	Chlorhexidine (0.2%)	At base line	2.3	Standard Deviation 0.9	units on a scale
Plaque Index	Punica Granatum Pleniflora Mouth Rinse	At base line	2.5	Standard Deviation 0.6	units on a scale
Plaque Index	Chlorhexidine (0.2%)	After 2 weeks	1.9	Standard Deviation 1	units on a scale
Plaque Index	Punica Granatum Pleniflora Mouth Rinse	After 2 weeks	2	Standard Deviation 0.7	units on a scale
Plaque Index	Chlorhexidine (0.2%)	After 4 weeks	0.2	Standard Deviation 0.2	units on a scale
Plaque Index	Punica Granatum Pleniflora Mouth Rinse	After 4 weeks	0.2	Standard Deviation 0.1	units on a scale
Bleeding Index	Chlorhexidine (0.2%)	At base line	0.133	Standard Deviation 0.097	units on a scale
Bleeding Index	Punica Granatum Pleniflora Mouth Rinse	At base line	0.148	Standard Deviation 0.123	units on a scale
Bleeding Index	Chlorhexidine (0.2%)	After 2 weeks	0.039	Standard Deviation 0.057	units on a scale
Bleeding Index	Punica Granatum Pleniflora Mouth Rinse	After 2 weeks	0.034	Standard Deviation 0.056	units on a scale

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Follow-up	STARTED	Chlorhexidine (0.2%)	40
First Follow-up	STARTED	Punica Granatum Pleniflora Mouth Rinse	40
First Follow-up	COMPLETED	Chlorhexidine (0.2%)	36
First Follow-up	COMPLETED	Punica Granatum Pleniflora Mouth Rinse	38
First Follow-up	NOT COMPLETED	Chlorhexidine (0.2%)	4
First Follow-up	NOT COMPLETED	Punica Granatum Pleniflora Mouth Rinse	2
Second Follow-up	STARTED	Chlorhexidine (0.2%)	36
Second Follow-up	STARTED	Punica Granatum Pleniflora Mouth Rinse	38
Second Follow-up	COMPLETED	Chlorhexidine (0.2%)	34
Second Follow-up	COMPLETED	Punica Granatum Pleniflora Mouth Rinse	36

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Unpleasant taste	Surgical and medical procedures	Chlorhexidine (0.2%)	14	36	14
other	Unpleasant taste	Surgical and medical procedures	Punica Granatum Pleniflora Mouth Rinse	15	38	15
other	Other side effects	Surgical and medical procedures	Chlorhexidine (0.2%)	4	36	4
other	Other side effects	Surgical and medical procedures	Punica Granatum Pleniflora Mouth Rinse	0	38	0
other	Discolored	Surgical and medical procedures	Chlorhexidine (0.2%)	3	36	3
other	Discolored	Surgical and medical procedures	Punica Granatum Pleniflora Mouth Rinse	0	38	0
other	Bad Odor	Surgical and medical procedures	Chlorhexidine (0.2%)	0	36	0
other	Bad Odor	Surgical and medical procedures	Punica Granatum Pleniflora Mouth Rinse	1	38	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Chlorhexidine (0.2%)
Total, all-cause mortality	Punica Granatum Pleniflora Mouth Rinse
Total, other adverse events	Chlorhexidine (0.2%)	21	36
Total, other adverse events	Punica Granatum Pleniflora Mouth Rinse	16	38
Total, serious adverse events	Chlorhexidine (0.2%)	0	36
Total, serious adverse events	Punica Granatum Pleniflora Mouth Rinse	0	38

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Chlorhexidine (0.2%) vs Punica Granatum Pleniflora Mouth Rinse: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT02227485/results?page=2

API reference For AI assistants