The objective of this research was clinical assessment of frankincense chewing gum efficacy on plaque–induced gingivitis. This randomized double blind plaque placebo controlled study was done in 74 high school students with moderate plaque induced gingivitis. The patients chewed frankincense (extract or powder) contained or control chewing gum 3 times daily. Gingival index, plaque index, bleeding index, pocket probe depth index in ramfjord teeth were measured at baseline and on the 7th and 14th days after the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901192547N1
Registration date:2010-05-15, 1389/02/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-15, 1389/02/25
Registrant information
Name
Arash Poorsattar
Name of organization / entity
Babol University of Medical Sciences (BUMS)
Country
Iran (Islamic Republic of)
Phone
+98 15 1321 6283
Email address
a.poorsattar@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy, Babol University of Medical Sciences
Expected recruitment start date
2004-04-03, 1383/01/15
Expected recruitment end date
2006-03-06, 1384/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Frankincense on moderate plaque induces gingivitis
Public title
Effect of Frankincense on gingival inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female high school student with moderate plaque induces gingivitis
Exclusion criteria: presence of any systemic diseases, consumption of any drug with effect on periodontium or any antibiotics within last month, severe maloccusion, mal oral habits, periodontal surgery or scaling within past 6 months, having large filling or severe subgingival caries in ramjford teeth
Age
From 15 years old to 18 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
74
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
Babol University of Medical Sciences
Street address
Ganj Afrooz ave.
City
Babol
Postal code
Approval date
empty
Ethics committee reference number
2453
Health conditions studied
1
Description of health condition studied
Chronic gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
Gingival index
Timepoint
days 0, 7, 14
Method of measurement
Loe & sillness index
Secondary outcomes
1
Description
plaque index
Timepoint
days 0, 7, 14
Method of measurement
Loe & Silness
2
Description
bleeding index
Timepoint
Baseline and on the 7th and 14th days after the begining of the study
Method of measurement
Cowel Index
3
Description
pockt probe depth index
Timepoint
Baseline and on the 7th and 14th days after the begining of the study
Method of measurement
WHO probe
Intervention groups
1
Description
gum contains either powder or extract of frankicense 3 times daily
Category
Treatment - Drugs
2
Description
control chewing gum (without frankincense) 3 times daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontology ward, Babol university of Medical Scicences
Full name of responsible person
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Babol University of Medcial Sciences
Full name of responsible person
Dr. Vahid Abbasi
Street address
Ganj Afrooz Ave.Dentistry school
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Babol University of Medcial 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
Babol university of Medcial Sciences
Full name of responsible person
Arash Poorsattar Bejeh Mir
Position
Dentistry student
Other areas of specialty/work
Street address
dentistry school, Babol university of Medcial Sciences,Ganj Arooz ave.