The aim of this study is to evaluate the efficacy of pomegranate seed extract and compare it with conventional irrigants i.e. chlorhexidine and a control (placebo) group in adjunction to scaling and root planning in chronic periodontitis patient.
The participants have at least one tooth with a pocket depth of 5 mm or more. In total, 60 periodontal pockets with a depth of 5 mm or more in each quadrant will be enrolled in the study. The cases having allergy to pomegranate, receiving scaling and root planing or getting antibiotics within the preceding three months and volunteers with any medical condition that may comprise periodontal condition will be excluded from the study.
20 patients with moderate to severe chronic periodontitis will participate in this study. They will be randomly selected from the patients seeking periodontal treatment in the periodontology department of dental school of medical sciences of shiraz university.
They will initially complete phase I of the experiment which consists of oral hygiene instructions (OHIs) and mechanical debridement. Subsequently scaling will be performed for all of the patients. Subsequently, one tooth from each quadrant will be chosen and randomly allocated to subgingival irrigation with one of the following solutions: (1) pomegranate seed extract (2) chlorhexidine 0.2 % 3) placebo (distilled water). At baseline and 6 weeks after the final scaling session the following clinical periodontal parameters such as Gingival index (GI) (Loe and sillnes) and bleeding index (BI) (lenox) and plaque index (PI) (oleary) will be measured. Subgingival irrigation will be done, 4 days after completing of the phase 1 of treatment. After completing of the irrigation periodontal dressing will be placed to the area and removed after 1 week. Subgingival irrigation will be performed 14 days after the first session of the irrigation again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081229308N1
Registration date:2016-10-03, 1395/07/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-03, 1395/07/12
Registrant information
Name
Hamed Rezaei
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3229 6369
Email address
rezaei_h@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of subgingival irrigation with pomegranate seed extract & chlorohexidine after scaling on chronic periodontitis
Public title
Evaluation the effect of pomegranate seed oil in the treatment of gum disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with moderate to severe chronic periodontitis; participants have at least one posterior tooth with a pocket depth of 5 mm or more in three different quadrants of the dentition.
Exclusion criteria : allergy to pomegranate; smoking habit; overhang restorations; requiring antibiotic prophylaxis prior to dental treatment; doing scaling and root planing or getting antibiotics within the preceding three months; pregnant women; medical condition that may comprise periodontal tissue.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients and therapists are not aware of the type of material used so there is double-blind study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Science, Zand Street, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2016-08-07, 1395/05/17
Ethics committee reference number
IR.SUMS.REC.1395.97
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
periodontal pocket
Timepoint
at baseline - 6 weeks after the final scaling session
Method of measurement
mili meter with Williams probe
2
Description
gingival index
Timepoint
at baseline - 6 weeks after the final scaling session
Method of measurement
Loe and sillnes score system
3
Description
bleeding index
Timepoint
at baseline - 6 weeks after the final scaling session
Method of measurement
lenod score system
4
Description
plaque index
Timepoint
at baseline - 6 weeks after the final scaling session
Method of measurement
in term of percentage by oleary method
Secondary outcomes
empty
Intervention groups
1
Description
intervention group
5 milliliter chlorhexidine 0.2 % solution as subgingival irrigation with insulin syringe gauge 23 after final scalin and root planing
Category
Treatment - Drugs
2
Description
intervention group
5 milliliter pomegranate seed extract as subgingival irrigation with insulin syringe gauge 23 after final scaling and root planing
Category
Treatment - Drugs
3
Description
control group
5 milliliter distilled water used as subgingival irrigation with insulin syringe gauge 23 after final scaling and root planing
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontics, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Dr. Farin Kiany Assistant Professor of periodontics
Street address
School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Sayed Basir Hashemi
Street address
Shiraz University of Medical Science, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Zahra Emami
Position
Assistant Professor of periodontics , School of Dentistry, Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 71 3626 4271
Fax
Email
Emamiz@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Farin Kiany
Position
Assistant Professor of periodontics
Other areas of specialty/work
Street address
Department of Periodontics, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 71 3626 4271
Fax
Email
Kianif@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamed Reazei
Position
Undergraduate Student of dentistry
Other areas of specialty/work
Street address
School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3626 4271
Fax
Email
rezaei_h@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)