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A Comparison of mouth rinse containing alcohol free chlorhexidine with a cetylpyridinium chloride in periodontal diseases

Protocol summary

Summary
Aim: clinical effectiveness of 0.05% cetylpyridinium chloride mouth rinse in patients with gingivitis as compared to non-alcoholic chlorhexidine mouth wash. Methods & Material: Twenty-four subjects, without systemic diseases, with plaque induced gingivitis will be selected for this study. The patients were treated with scaling and rootplaning at the baseline; Oral hygiene instructions were given that included brushing twice- daily, The volunteers brushed their teeth with the Bass brushing technique for at least 2 minutes, these patients were randomly ,equally divided into two groups, Group A: perform daily mouthwashes twice a day with the solution containing 10 ml of 0.05 cetylpyridinium, (Vi-one, Rojin, Cosmetic-Lab, Kurdistan -Iran), Group B: use daily mouthwashes twice a day with 10ml of the chlorhexidine(Kin Labratories, Spain), On day 0,7,15 and day 21 of each phase the Plaque Index (PI), Pocket depth(PD), Stain Index(SI) and Bleeding Index (BI) of each volunteer were measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014051717587N6
Registration date: 2014-08-28, 1393/06/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-28, 1393/06/06
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
Invetigator
Expected recruitment start date
2014-07-10, 1393/04/19
Expected recruitment end date
2015-04-10, 1394/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of mouth rinse containing alcohol free chlorhexidine with a cetylpyridinium chloride in periodontal diseases
Public title
Randomized, Double blind clinical study alcohol free chlorhexidine with a cetylpyridinium chloride mouth rinses in periodontal diseases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: adult patients, older than 18 years old, systemically healthy, and having at least 20 teeth. Exclusion criteria: patients with cavitated caries, no periodontal pockets larger than 4 mm, orthodontic appliances or removable prostheses, allergies to cetylpyridinium or CHX, use of antibiotics and anti-inflammatory drugs in the past 3 months that might alter normal gingival health, oral prophylaxis outside of study; use of oral chlorhexidine products or participation in an oral rinse study within 3 months prior to baseline examination, pregnancy or nursing, smoking.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the patients were randomly (Balanced Block Randomization) equal divided into two groups.

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
2010-09-23, 1389/07/01
Ethics committee reference number
483

Health conditions studied

1

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

Primary outcomes

1

Description
Reduction of pocket depth
Timepoint
One month
Method of measurement
Periodontal pobe

Secondary outcomes

1

Description
Reduction of plaque index
Timepoint
One month
Method of measurement
Plaque Index (O’Leary)

2

Description
Reduction of bleeding on probing
Timepoint
One month
Method of measurement
Bleeding index (Carterand Barnes)

Intervention groups

1

Description
Group A: perform daily mouthwashes twice a day with the solution containing 10 ml of 0.05 cetylpyridinium, (Vi-one, Rojin, Cosmetic-Lab, Kurdistan -Iran).
Category
Treatment - Drugs

2

Description
Group B: use daily mouthwashes twice a day with 10ml of the non- alcoholic chlorhexidine (Kin Labratories, Spain).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Tehran Denatl Branch
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
19858/172
Phone
+98 21 2284 0604
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, 10th Neyestan Alley, Pasdarn 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
Periodologist, 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
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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