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A comparative evaluation of the effect of sub-gingival irrigation with ibuprofen 2% mouthwash in treatment of periodontal diseases.

Protocol summary

Summary
Aim : Use an ibuprofen mouthwash 2% irrigate subgingival in improving progression of periodontal diseases can be evaluated. Materials and Methods: 22 patients with chronic periodontitis without any systemic disease who have had periodontal disease, and 2 molars that have periodontal pockets deeper than 4 mm on either side of the lower jaw have the clinical examinations. Interventions: For patients who participated in this study, subjects who received oral hygiene instruction and scaling root planing (SRP), After 2 weeks, They were divided into two groups as determined by randomization in this study, Experimental group: ibuprofen 2% mouthwash (made from the Faculty of Pharmaceutical Sciences, Islamic Azad University, Tehran), Control group: placebo, Sub-gingival Irrigation of ibuprofen 2% mouthwash with an insulin syringe 0.5 ml were rinsed, Clinical measurements including probing depth (PD), clinical attachment levels (CAL), Plaque Index (PI), and Bleeding Index (BI) were recorded and the patients were recalled per once every 2 weeks for 3 months is repetitive, and at the end of 3 months, were evaluated changes in clinical periodontal parameters .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014050917587N4
Registration date: 2014-07-07, 1393/04/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-07-07, 1393/04/16
Registrant information
Name
Amirhossein Farahmand
Name of organization / entity
Dental Branch Islamic Azad University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2284 9604
Email address
perio-implant@hotmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-11-01, 1392/08/10
Expected recruitment end date
2015-09-01, 1394/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative evaluation of the effect of sub-gingival irrigation with ibuprofen 2% mouthwash in treatment of periodontal diseases.
Public title
A Randomized, Double-Blind, split-mouth, Placebo-controlled, clinical trial of the effect of sub-gingival irrigation with ibuprofen mouthwash in treatment of periodontal Diseases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: The patients systemically healthy were selected for the study. The subjects had with periodontal pocket depths of more than 4 mm on at least two teeth in mandibular molar area that observed on probing. Exclusion Criteria: Existing systemic disease; Hypersensitive to Ibuprofen; The use of any Antibiotic or Anti-inflammatory drugs within the 6 months preceding the beginning of the study; Cancer; Pregnant or nursing females; Smoking; Orthodontic treatments; Extensive dental restorations; Use removal denture; Mouth rinses; during the entire period of the study.
Age
From 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 22
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
Ethics Committee of Dental Branch, Islamic Azad University of Tehran
Street address
No4, 10th Neyestan Alley, Pasdaran Ave,Tehran,Iran
City
Tehran
Postal code
19585/175
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
2161

Health conditions studied

1

Description of health condition studied
Periodontal disesaes
ICD-10 code
k05.3
ICD-10 code description
Periodontal disesaes

Primary outcomes

1

Description
Pocket depth
Timepoint
15 Days
Method of measurement
Periodontal pobe

2

Description
Clinical attachment level
Timepoint
15 Days
Method of measurement
Periodontal probe

Secondary outcomes

1

Description
Reduction of bleeding on probing
Timepoint
3 Months
Method of measurement
Periodontal probe

2

Description
Reduction of Plaque Index
Timepoint
3 Months
Method of measurement
Loe & Silness Index

Intervention groups

1

Description
Ibuprofen 2% mouthwash (made from the Faculty of Pharmaceutical Sciences, Islamic Azad University, Tehran)
Category
Treatment - Drugs

2

Description
Placebo Mouthwash (Made by the Faculty of Pharmaceutical Sciences, Islamic Azad University of Tehran)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental Branch, Islamic Azad University of Tehran
Full name of responsible person
Amirhossein Farahmand
Street address
No4, 10th Neyestan Alley, Pasdarn Ave,Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research Council Of Dental Branch, Islamic Azad University of Tehran
Full name of responsible person
Amirhossein Farahmand
Street address
No 4, 10th Neyestan Alley, Pasdaran Ave, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research Council Of Dental Branch, Islamic Azad University of Tehran
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 Branch, Islamic Azad University of Tehran
Full name of responsible person
Amirhossein Farahmand
Position
Periodontologist and Implantologist
Other areas of specialty/work
Street address
No4, 10th Neyestan Alley, Pasdaran Ave, Tehran, Iran
City
Tehran
Postal code
19585/175
Phone
+98 21 2284 9604
Fax
Email
perio-implant@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental Branch, Islamic Azad University of Tehran
Full name of responsible person
Amirhossein Farahmand
Position
Periodontologist, Implantologist
Other areas of specialty/work
Street address
No 4, 1oth Neyestan Alley, Pasdaran Ave,Tehran, Iran
City
Tehran
Postal code
19585/175
Phone
+98 21 2284 9604
Fax
Email
perio-implant@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dental Branch, Islamic Azad University of Tehran
Full name of responsible person
Amirhossein Farahmand
Position
Periodontologist, Implantologist
Other areas of specialty/work
Street address
No 4, 10 th Neyestan Alley, Pasdaran Ave,Tehran, Iran
City
Tehran
Postal code
19585/175
Phone
+98 21 2284 9604
Fax
Email
perio-implant@hotmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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