Comparative evaluation of salivary substantivity and antiplaque efficacy of mouthwashes containing chlorhexidine, cetylpyridinium chloride and Salvarora Persica in gingivitis patients
The aim of this study is to evaluate the salivary substativity and antiplaque efficacy of five mouthwashes including three different chlorhexidine in 0.2% and 0.12% concentration; and two mouthwashes containing Cetylpyredinium chloride and Persica, and also normal saline as negative control. 16 volunteers aged 18 and above; having gingivitis divided in 6 groups (Groups1 to 4: each 3 volunteers and groups 4 and 5: 2 each) participated in this study. Volunteers in 6 groups will use all the mouthwashes in both parts of the study in a cross over design with washout period of 10 days. will take part in Upon obtaining written consent; for the first part of study, 1cc of unstimulated saliva will be collected at base line and 30 seconds, 1, 3, 5 and 7 hours after single use of10cc of mouth wash and evaluate for bacterial vitality by Live Dead Backlight Fluorescence kit (Invitrogen, U.S.A). Live and dead bacteria upon absorbing coloring agent to DNA will be appeared in green and red respectively under microscope and will be counted. Upon completion of first part in all groups, for clinical evaluation, after oral prophylaxis, they will be asked to abstain from all plaque control measures and just use the allocated mouthwash, 10cc twice daily for four days. After 4 days amount of plaque of the volunteers who abstain from all hygienic method for 12-18 hours will be measured with Turesky plaque index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204289582N1
Registration date:2013-12-02, 1392/09/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-02, 1392/09/11
Registrant information
Name
Mahmood Ghasemi
Name of organization / entity
Dental unit, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
m_ghasemi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research; Dental Unit; Tehran Islamic Azad University
Expected recruitment start date
2012-12-06, 1391/09/16
Expected recruitment end date
2014-04-01, 1393/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of salivary substantivity and antiplaque efficacy of mouthwashes containing chlorhexidine, cetylpyridinium chloride and Salvarora Persica in gingivitis patients
Public title
Effect of mouthwash on gingival disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria; 18 years and above; minimum of 24 teeth; no partial or fixed prosthesis and not under orthodontic treatment; no gingival sulcus deeper than 3mm; maximum plaque index( Turesky et al) of 2 and gingival index( Loa and Silness) of 1.5
Exclusion criteria: Age above 45 years, not smoker; no antibiotic therapy or routine antiseptic use for past 3 months; allergy to any mouth washes; no patient compliance
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
The design of study is cross over and each volunteer in each group with a washout period of 10 days for each mouthwash, will participate in both parts of the study and will use all the studied mouthwashes. The details are presented in the intervention section.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Commitee,Deputy of Research , Dental school , Tehran Islamic Azad University
Street address
No:4; 10th Neyestan; Pasdaran Ave
City
Tehran
Postal code
Approval date
2011-10-04, 1390/07/12
Ethics committee reference number
645
Health conditions studied
1
Description of health condition studied
prevention of periodontal diseases
ICD-10 code
k05
ICD-10 code description
Gingivitis and periodontal disease
Primary outcomes
1
Description
Number of vital bacteria
Timepoint
before and after 30 second; 1; 3; 5 and 7 hours of single use of 10cc of mouthwash for 45 seconds
Method of measurement
Epiflourescence
2
Description
bacterial Plaque
Timepoint
4 days after use
Method of measurement
Turesky Plaque Index
Secondary outcomes
1
Description
Change in taste sensation
Timepoint
4 days
Method of measurement
Visual Analog Scale
2
Description
Burning sensation
Timepoint
4 days
Method of measurement
Visual analog Scale
3
Description
Presence of stain
Timepoint
4 days
Method of measurement
Observation
Intervention groups
1
Description
Group 1: First part: Salivary substantivity of mouthwashes:
1- 0.12% local Chlorhexidine mouthwash, once 10cc for 30 Sec.
2- Persica mouthwash, once 10cc for 30 Sec.
3- 0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, once 10cc for 30 Sec.
4- CPC (Oral-B) mouthwash, once 10cc for 30 Sec.
5- 0.2% local Chlorhexidine mouthwash, once 10cc for 30 Sec.
6- Normal saline, once 10cc for 30 Sec.
Group 1: Second part: Four days anti plaque efficacy:
1- 0.12% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
2- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
3- 0.12% Chlorhexidine Kin Gingival( Spain)mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
4- CPC (Oral-B) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
5- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
6- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days.
Category
Treatment - Drugs
2
Description
Group 2: First part: Salivary substantivity of mouthwashes:
1- Normal saline, once 10cc for 30 Sec.
2- 0.12% local Chlorhexidine mouthwash, once 10cc for 30 Sec.
3- Persica mouthwash, once 10cc for 30 Sec.
4- 0.12% Chlorhexidine Kin Gingival (Spain) once 10cc for 30 Sec.
5- CPC (Oral-B) mouthwash, once 10cc for 30 Sec.
6- 0.2% local Chlorhexidine, once 10cc for 30 Sec.
Group 2: Second part: Four days anti plaque efficacy of mouthwash.
1- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days.
2- 0.12% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
3- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
4- 0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
5- CPC (Oral-B) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
6- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
Category
Diagnosis
3
Description
Group 3: First part: Salivary substantivity of mouthwashes:
1- Persica mouthwash, once 10cc for 30 Sec.
2- 0.12% Chlorhexidine Kin Gingival( Spain, once 10cc for 30 Sec.
3- CPC (Oral-B), once 10cc for 30 Sec.
4- 0.2% local Chlorhexidine, once 10cc for 30 Sec.
5- Normal saline once 10cc for 30 Sec.
6- 0.12% local Chlorhexidine. once 10cc for 30 Sec.
Group 3: Second part: Four days anti plaque efficacy of mouthwash.
1- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
2- 0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
3- CPC (Oral-B) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
4- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
5- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days.
6- - 0.12% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
Category
Diagnosis
4
Description
Group 4: First part: Salivary substantivity of mouthwashes:
1- 0.12% Chlorhexidine Kin Gingival (Spain) once 10cc for 30 Sec.
2- CPC (Oral-B) mouthwash, once 10cc for 30 Sec.,
3- 0.2% local Chlorhexidine mouthwash, once 10cc for 30 Sec.
4- Normal saline once 10cc for 30 Sec.
5- 0.12% local Chlorhexidine, once 10cc for 30 Sec.
6- Persica mouthwash once 10cc for 30 Sec.
Group 4: Second part: Four days anti plaque efficacy of mouthwash.
1-0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
2- CPC (Oral-B) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
3- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
4- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days.
5- - 0.12% local chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
6- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days
Category
Diagnosis
5
Description
Group 5: First part: Salivary substantivity of mouthwashes:
1- CPC (Oral-B) mouthwash, once 10cc for 30 Sec., .
2- 0.2% local Chlorhexidine mouthwash, once 10cc for 30 Sec.
3- Normal saline, once 10cc for 30 Sec.
4- 0.12% local Chlorhexidine mouthwash, once 10cc for 30 Sec.
5- Persica mouthwash, once 10cc for 30 Sec.
6- 0.12% Chlorhexidine Kin Gingival (Spain) once 10cc for 30 Sec.
Group 5: Second part: Four days anti plaque efficacy of mouthwash.
1- CPC (Oral-B) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
2- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
3- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days.
4- - 0.12% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
5- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
Category
Diagnosis
6
Description
Group 6: First part: Salivary substantivity of mouthwashes:
1- 0.2% local chlorhexidine mouthwash, once 10cc for 30 Sec.
2- Normal saline, once 10cc for 30 Sec.
3- 0.12% local Chlorhexidine mouthwash, once 10cc for 30 Sec.
4- Persica mouthwash, once 10cc for 30 Sec.
5- 0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, once 10cc for 30 Sec.
6- CPC (Oral-B) mouthwash, once 10cc for 30 Sec.
Group 5: Second part: Four days anti plaque efficacy of mouthwash.
1- 0.2% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
2- Normal saline, 10 cc for 30 Sec. twice a day and for 4 days.
3- - 0.12% local Chlorhexidine mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
4- Persica mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
5- 0.12% Chlorhexidine Kin Gingival (Spain) mouthwash, 10 cc for 30 Sec. twice a day and for 4 days.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School, Tehran Islamic Azad University
Full name of responsible person
Mahmood Ghasemi
Street address
No:4, 10th Neyestan, Pasdaran Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental School, Tehran Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No:4, 10th Neyestan,Pasdaran Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental School, Tehran Islamic Azad University
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
Dentla school, Tehran Islamic Azad University
Full name of responsible person
Mahmood Ghasemi
Position
Associate Professor
Other areas of specialty/work
Street address
No:4, 10th Neyestan,Pasdaran Ave.
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
Email
m_ghasemi@dentaliau.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental school, ،Tehran Islamic Azad University
Full name of responsible person
Mahmood Ghasemi
Position
Periodontist
Other areas of specialty/work
Street address
No:4, 10th Neyestan,Pasdaran Ave.
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
Email
m_ghasemi@dental.iau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental School, Tehran Islamic Azad University
Full name of responsible person
Mahmood Ghasemi
Position
Periodontist/Associate Professor
Other areas of specialty/work
Street address
No:4, 10th Neyestan,Pasdaran Ave.
City
Tehran
Postal code
Phone
+212 2564571
Fax
Email
m_ghasemi@dental.iau.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)