This study was aimed to evaluate the histological evaluation of the therapeutic effects and the clinical findings of the dental gel that included Berberis on gingival inflammation. In this study, 15 patients referred to the periodontology department of the Mashhad University of Medical Sciences, Iran and suffering from moderate to severe chronic periodontitis (according to AAP classification) were examined. Soft splint was provided for both jaws with the gap in central parts of teeth. Patients were asked to use semi-full splint of Berberis gel on one side and placebo gel on another side of jaw every night for two weeks. PI and GI were measured at the baseline, one and two weeks after intervention. Gum biopsy specimens were also obtained for the histological investigation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138804302216N1
Registration date:2009-10-26, 1388/08/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-10-26, 1388/08/04
Registrant information
Name
Mahboobeh Shabzendedar
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 9501
Email address
shabzendedarm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellery for research, Mashhad University of Medical Sciences
Expected recruitment start date
2008-01-21, 1386/11/01
Expected recruitment end date
2008-10-22, 1387/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Histological evaluation of clinical effect of topical application of barberries dental gel on the gingival inflammation
Public title
Histological evaluation of clinical effect of topical application of barberries dental gel on the gingival inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients suffering from moderate to severe chronic periodontitis (according to AAP classification) referred to the Periodontology, Department of Mashhad University of Medical Sciences, Iran.
Exclusion criteria: Presence of immunodeficiency, presence of diabetes, consumption of antibiotic during 3 months prior to study, using antibacterial mouth rinse, use of contraceptive drugs, presence of hematologic disorder, smoking
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ghoreishi building, Mashhad University of Medical Sciences, Daneshgah St,
City
Mashhad
Postal code
Approval date
empty
Ethics committee reference number
87023
Health conditions studied
1
Description of health condition studied
Periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis complex
Primary outcomes
1
Description
Improvement of gingivitis
Timepoint
Two week after use of test gel
Method of measurement
Surgery area and gum-biopsy specimens were obtained for the histological investigation.
Secondary outcomes
empty
Intervention groups
1
Description
Placebo gel, in soft splint, every night for two weeks
Category
Treatment - Drugs
2
Description
Berberin gel, in soft splint, every night for two weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodentology deprtment of Mashhad Dental School
Full name of responsible person
Dr Moeen Taghavi
Street address
Periodentology department, Dental School, Vakil abad Ave.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery for research, Mashhad University of Medical Sciences
Full name of responsible person
Abass Makarem
Street address
Ghoreishi building, Daneshgah St., Vice chancellery for research, Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for research, Mashhad 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
Dental School
Full name of responsible person
Mahboobeh Shabzendedar
Position
Assistant professor
Other areas of specialty/work
Street address
Pediateric Department, Dental school, Vakil abad Ave
City
Mashhad
Postal code
91775-984
Phone
+98 51 1882 9501
Fax
Email
shabzendedarm@mums.ac.ir
Web page address
www.mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abass Makarem
Position
Professor
Other areas of specialty/work
Street address
Pediateric Department. Dental School , Vakil abad Ave
City
Mashhad
Postal code
91775-984
Phone
+98 511882950115
Fax
+98 51 1842 0305
Email
makarema@mums.ac.ir
Web page address
www.mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Dental School
Full name of responsible person
Mahboobeh Shabzendedar
Position
Assistant Professor
Other areas of specialty/work
Street address
Pediateric Department, Dental School, Vakil abad Ave.
City
Mashhad
Postal code
91775-984
Phone
+98 51 1882 9501
Fax
Email
shabzendedarm@mums .ac.ir
Web page address
www.mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)