This study will be done to evaluate the effect of phase I periodontal (oral hygiene instructions, scaling and root planning) to determine frequency of “Trichomonas tenax” and “Entomoeba gingivalis” in saliva and plaque samples of patients before intervention and 3 weeks after that. The studied population includes patients suffering from moderate to severe chronic periodontitis who referred to Dental college of Yazd. After determining the severity of disease, patients randomly are categorized into two groups named case and control using a table of random numbers. Sampling will be done in two phase, during a 3 weeks interval. Control group will be received oral hygiene instructions; phase I periodontal will be done on case group after first sampling. The second samples will be prepared and sent to the Parasitology lab after 3 weeks. During the study, the person who collects saliva and dental plaque is not aware of presence and frequency of these oral parasites and this study is a single blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014071013167N4
Registration date:2014-09-09, 1393/06/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-09, 1393/06/18
Registrant information
Name
Maryam Nourelahi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1725 5873
Email address
m.noorelahi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2014-07-19, 1393/04/28
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect scaling and root planning on the Trichomonas tenax and Entomoeba gingivalis in patients with chronic periodontitis
Public title
Effect of scaling and root planning on two types of parasites, Trichomonas tenax and Entomoeba gingivalis in patients with chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Persons between the ages of 30 to 55 years, no history of periodontal treatment (scaling) in the past six months, no history of antibiotic therapy within the previous three months and not taking effective drugs on periodontium (medications that suppress the immune system, reducing hypertension, anticonvulsants, contraceptives, etc.), lack of systemic diseases such as diabetes or heart disease, no pregnancy, no smoking or other drug abuser;
Exclusion criteria: those who do not have the entry criteria and who after baseline sampling do not return after three weeks
Age
From 63 years old to 38 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar Squ,Yazd,Iran
City
Yazd
Postal code
89195/165
Approval date
2014-05-03, 1393/02/13
Ethics committee reference number
پ/17/1/31877
Health conditions studied
1
Description of health condition studied
chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic pericoronitis Periodontitis: NOS complex simplex
Primary outcomes
1
Description
Frequency of Trichomonas tenax and Entomoeba gingivalis
Timepoint
Before intervention (oral education instruction, scaling and root planning) and three weeks after that
Method of measurement
Saliva and plaque are collected by pipet and sterile curette respectively. Collected samples are fixed then are prepared by Giemsa staining and read ¼ of Prepared smear whit optical microscope
Secondary outcomes
1
Description
Pocket depth
Timepoint
Before and three weeks after the intervention
Method of measurement
Millimeters
2
Description
Bleading on probing
Timepoint
Before and three weeks after the intervention
Method of measurement
A percent by Gingival Sulcus Bleeding Index
Intervention groups
1
Description
Intervention group: phase I of periodontal treatment ( oral hygiene instruction, scaling and root planning)
Category
Prevention
2
Description
Control group: oral hygiene instruction
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontics, Shahid Sadoughi Dentistry University
Full name of responsible person
Dr.Fahimeh Rashidi Meibodi
Street address
Dentistry University, Dahe Fajr Blvd, Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Fahimeh Rashidi Meibodi
Street address
Dentistry University, Dahe Fajr Blvd, Yazd, Iran
City
Yazd
Grant name
----------------------------------
Grant code / Reference number
--------------------------
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Shahid Sadoughi Dentistry University
Full name of responsible person
Dr. Akram Zafarbakhsh
Position
Resident of Periodontics
Other areas of specialty/work
Street address
Dentistry faculty, Dahe Fajr Blvd, Yazd, Iran
City
Yazd
Postal code
89195/165
Phone
+98 351621222
Fax
+98 35 1625 0344
Email
zafarbakhsh.akram@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dentistry faculty of Shahid Sadoughi University
Full name of responsible person
Dr. Akram Zafarbakhsh
Position
Resident of Periodontics
Other areas of specialty/work
Street address
Dentistry University, Dahe Fajr Blvd, Yazd, Iran
City
Yazd
Postal code
89195/165
Phone
+98 351621222
Fax
+98 35 1625 0344
Email
zafarbakhsh.akram@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dentistry faculty of Shahid Sadoughi University
Full name of responsible person
Dr. Akram Zafarbakhsh
Position
Postgraduate Periodontics / General practitioner
Other areas of specialty/work
Street address
Dentistry faculty, Dahe Fajr Blvd, Yazd, Iran
City
Yazd
Postal code
89195/165
Phone
+98 35 1625 5881
Fax
+98 35 1625 0344
Email
zafarbakhsh.akram@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)