Studies have shown that the use of local-delivery nanoparticles improves the biological impact of drugs, resulting in faster penetration and greater access, reduced cytotoxicity, drug dosage and, costs. Given the positive effect of chlorhexidine in the treatment of patients with periodontitis and the side effects of conventional methods, we aim to evaluate the effect of chlorhexidine nanoparticles on the clinical parameters of patients with periodontitis.
Design
16 patients are divided into two groups: for control, scaling and root planing are performed. For the case group, we do scaling and root planning for all patients and put the Nano-CHX in the pocket and inform the patient not to consume anything for up to 30 minutes.
Settings and conduct
The study is performed on patients referring to the periodontology department of Dental School of Qazvin University. The practitioner, the statistics consultant and, the patients are blind
Participants/Inclusion and exclusion criteria
The study is a clinical trial on 16 patients with moderate to severe periodontitis.
Intervention groups
After confirming the diagnosis of moderate or severe periodontitis, we perform clinical examinations (PD, BOP, CAL) and remove the supragingival plaque for all of them.
Main outcome variables
probing depth; clinical attachment loss; plaque and BoP index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191115045450N1
Registration date:2019-12-03, 1398/09/12
Registration timing:prospective
Last update:2019-12-03, 1398/09/12
Update count:0
Registration date
2019-12-03, 1398/09/12
Registrant information
Name
mohamadjavad karamshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3365 0315
Email address
mr.karamshahi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-01-05, 1398/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of nano-chlorhexidine on clinical parameters in patients with periodontitis.
Public title
effect of nano-chlorhexidine on treatment of periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with chronic moderate to severe periodontitis
no systemic disease
no aggressive periodontitis
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients are treated split-mouth and similarly.
The information is coded to the researcher and statistical analyzer
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
No. 38, Naddaf Ave., Nokhbegan Blvd., Qazvin Town
City
Qazvin
Province
Tehran
Postal code
3415851856
Approval date
2019-04-28, 1398/02/08
Ethics committee reference number
IR.AJAUMS.REC.1398.013
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
probing depth
Timepoint
4 weeks later
Method of measurement
periodontal probe
2
Description
clinical attachment loss
Timepoint
4 weeks later
Method of measurement
periodontal probe
3
Description
recession
Timepoint
4 weeks
Method of measurement
periodontal probe
4
Description
plaque and BoP index
Timepoint
4 weeks
Method of measurement
periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: nanochlorhexidine use
Category
Treatment - Drugs
2
Description
Control group: nothing
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences, Dental School, Periodontics Department
Full name of responsible person
Mohamadjavad Karamshahi
Street address
Qazvin University of Medical Sciences, Dental School, Periodontics Department
City
Qazvin
Province
Qazvin
Postal code
3415851856
Phone
+98 28 3365 0315
Email
mr.karamshahi@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
mohamadjavad karamshahi
Street address
No. 38, Naddaf Ave., Nokhbegan Blvd., Qazvin Town
City
Tehran
Province
Tehran
Postal code
3415851856
Phone
+98 28 3365 0315
Email
mr.karamshahi@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
mohamadjavad karamshahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 38, Naddaf Ave., Nokhbegan Blvd., Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
3415851856
Phone
+98 28 3365 0315
Email
mr.karamshahi@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
mohamadjavad karamshahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 38, Naddaf Ave., Nokhbegan Blvd., Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
3415851856
Phone
+98 28 3365 0315
Email
mr.karamshahi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
mohamadjavad karamshahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 38, Naddaf Ave., Nokhbegan Blvd., Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
3415851856
Phone
+98 28 3365 0315
Email
mr.karamshahi@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available