Preparation and clinical trial of tooth paste contained Pistacia atlantica subsp. mutica oleo-gum resin, Punica granatum var. pleniflora flowers and Eugenia caryophyllata buds for halitosis
The aim of this study is to evaluating effect of a toothpaste contained mastic resin, pomegranate and clove oil and clinical assessment of oral malodor. Exclusion criteria are systemic diseases, use of antibiotics and drugs causing dry mouth. This double blind study possesses the assessment of plaque and bleeding and halitosis factors at the beginning as well as end of 2 weeks application of tooth paste twice a day administration. The results will be analyzed according to statistical assesses.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030921395N1
Registration date:2016-08-30, 1395/06/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-30, 1395/06/09
Registrant information
Name
Atefeh Arabzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4128
Email address
arabzade_a@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-01-01, 1394/10/11
Expected recruitment end date
2017-01-01, 1395/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation and clinical trial of tooth paste contained Pistacia atlantica subsp. mutica oleo-gum resin, Punica granatum var. pleniflora flowers and Eugenia caryophyllata buds for halitosis
Public title
Effect of Pistacia atlantica subsp. mutica oleo-gum resin, Punica granatum var. pleniflora flowers and Eugenia on halitosis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Organoleptic score ≥2; Tongue coating score ≥4
exclusion criteria: smoking; alcohol; systemic disease; medicinal causing dry month; use of antibiotics in the past month; Eating spicy foods, onions and garlic in the 48 hours prior to the examination;
Using orthodontic appliance (fixed and mobile) and mobile dentures; diabetes; metabolic disease; infections of the upper respiratory tract; kidney and liver failure, chronic inflammatory diseases; surgery of the head and neck malignancies; anticoagulation therapy such as aspirin; heparin; warfarin.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
1
Registry name
معاونت پژوهشی و فناوری دانشگاه علوم پزشكی شيراز
Secondary trial Id
C.T-9375-7245
Registration date
1393-08-01, 773/01/-231
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor for Research, Shiraz University of Medical Sciences
Street address
Zand Blvd., Shiraz, Iran
City
Shiraz
Postal code
71345-1978
Approval date
2014-10-23, 1393/08/01
Ethics committee reference number
C.T-9375-7245
Health conditions studied
1
Description of health condition studied
Halitosis
ICD-10 code
R19.6
ICD-10 code description
Halitosis
Primary outcomes
1
Description
Halitosis
Timepoint
2 weeks
Method of measurement
plaque index, bleeding index and halitosis check list
Secondary outcomes
1
Description
microbial contamination
Timepoint
2 weeks
Method of measurement
microbial contamination of salivary
2
Description
aproximal plaque index
Timepoint
2 weeks
Method of measurement
aproximal plaque index
3
Description
tounge coating
Timepoint
2 weeks
Method of measurement
tounge coating
4
Description
sulcus bleeding index
Timepoint
2 weeks
Method of measurement
sulcus bleeding index
Intervention groups
1
Description
herbal toothpaste have been used for two weeks in oral cavity.
Category
Treatment - Drugs
2
Description
placebo is used in oral cavity for 2 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry faculty of shiraz university of medical sciences