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Evaluate and compare the efficacy of aloe Vera mouthwash with non- alcoholic Chlorhexidine mouthwash on periodontal diseases.

Protocol summary

Summary
Aim: To compare the efficacy of Aloe Vera and non-alcoholic chlorhexidine mouthwash in the treatment of Periodontal diseases. Methods &Material: 24 patients were selected, the following periodontal parameters were recorded at baseline, and after recording all the parameters at the baseline, Scaling, root planning, and polishing are done for all the patients participating in the study. Oral hygiene instructions were given that included brushing twice a day with a soft brush, After 2 weeks, patients in the study, they were randomly (Balanced Block Randomization) equal divided into 2 groups; Group A: mouthwash aloe Vera (Alodent Co. UK) for each patient, Group B: Non-alcoholic Chlorhexidine (Perio-Kin, Livar CO. Spain) 10 ml by patients routinely washed two times in one day for about 30 seconds and lasts for 15 days, then every 7 days periodontal parameters, and at the end of 2 weeks (days 0, 7, 15) clinical changes are evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014051017587N5
Registration date: 2014-08-15, 1393/05/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-15, 1393/05/24
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
2014-07-18, 1393/04/27
Expected recruitment end date
2015-07-28, 1394/05/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate and compare the efficacy of aloe Vera mouthwash with non- alcoholic Chlorhexidine mouthwash on periodontal diseases.
Public title
Randomized, clinical trial to evaluate the effects of aloe vera mouthwash in comparison with non-alcoholic chlorhexidine on periodontal disease .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of two periodontal sites located on the same side pocket depth 4 mm or more, Chronic periodontitis patients. Exclusion criteria: Orthodontic treatment, Use removal denture. Presence of vertical bone defect, Use of medicine therapy within the 3 months prior to the study, Allergy to chlorhexidine and Aloe Vera, smoking. Systemic diseases that could influence the course of periodontal disease, Pregnancy and lactation, Aggressive periodontitis, Furcation involvement, Periodontal therapy 6 months prior to the study, Extensive caries.
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
487

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
7days
Method of measurement
Periodontal pobe

Secondary outcomes

1

Description
Reduction of bleeding on probing
Timepoint
7 days
Method of measurement
Periodontal probe

2

Description
Reduction of plaque index
Timepoint
7 days
Method of measurement
Plaque Index(O’Leary )

Intervention groups

1

Description
"Group A: mouthwash aloe Vera (Alodent Co. UK) for each patient, 10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks."
Category
Treatment - Drugs

2

Description
"Group B: Non-alcoholic chlorexidine (Livar CO. SPAIN) for each patient,10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks."
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, 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 ofTehran
Full name of responsible person
Amirhossein Farahmand
Position
Periodontologist, Implantologist
Other areas of specialty/work
Street address
No 4, 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

Sharing plan

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