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Evaluation of zinc acetate Efficacy in chlorhexidin toothpaste as an adjunct on dental stain, gingival and plaque index

Protocol summary

Summary
Introduction: Bacterial plaque is the most important factor in periodontal diseases. However due to the limitation of mechanical plaque control methods, chemical materials are used as Supplements. Chlorhexidine (CHX) is one of the most effective materials in chemical plaque control, but because of cationic effect of CHX and interaction with anionic materials of toothpastes, its effectiveness is reduced. Therefore, in the present study, we compared Crest ANTI-Cavity toothpaste with KIN gingival and ORTHOKIN toothpastes that contained CHX. Methods: This clinical trial study carried out on 30 patients who had gingivitis. The patients were classified in 3 groups (each 10).Scaling and Root Planning (SRP) was performed on patients and plaque index and Bleeding index were recorded on the same session. After 14 days, the patients examined again and the aforementioned toothpastes were used twice daily. After 14 day, the patients were examined for the third time and BOP and plaque index were recorded. Results: According to the examinations, the average BOP in the 3rd meeting for the, ORTHOKIN, Crest ANTI_CAVITY and KIN gingival was %10.54, %12.15 and %10.6 respectively, also the plaque index in the 3rd meeting was %32.22, %50.35 and %27.8. In these 3 groups, BOP didn’t have a reduction while the plaque index significantly differed between ORTHOKIN and KIN gingival compared to Crest ANTI_Cavity (P<0.05).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016101330289N1
Registration date: 2017-01-09, 1395/10/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-09, 1395/10/20
Registrant information
Name
Mohadeseh Arabsolghar
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3245 9847
Email address
m.a.solghar@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
besat reserach center
Expected recruitment start date
2011-12-31, 1390/10/10
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of zinc acetate Efficacy in chlorhexidin toothpaste as an adjunct on dental stain, gingival and plaque index
Public title
effect of zinc on treatment of gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the patients with gingivitis that have a minimum of 24 natural permanent teeth; gingival index II which is defined as moderate inflammation; redness, edema and glazing; bleeding on probing. exclusion criteria: smoking; dental prosthesis; orthodontic devices; administration of antibiotics; anti-inflammatory drugs; the presence of any systemic disease; less than 24 permanent teeth
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
, Kerman Oral and Dental Diseases Research Center AND Kerman Social Determinants on Oral Health Rese
Street address
, Kerman Oral and Dental Diseases Research Center AND Kerman Social Determinants on Oral Health Research Center AND Department of Periodontics, School of Dentistry, Kerman University of Medical Sciences, Kerman, Iran
City
kerman
Postal code
Approval date
2012-07-05, 1391/04/15
Ethics committee reference number
k/91/378

2

Ethics committee
Name of ethics committee
Besat research center
Street address
kerman
City
kerman
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
k/91/378

Health conditions studied

1

Description of health condition studied
gingivitis
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases

Primary outcomes

1

Description
plaque index, , gingival index
Timepoint
14 dayes
Method of measurement
disclosing agent, probing

Secondary outcomes

1

Description
stain index
Timepoint
dayes 14
Method of measurement
disclosingg agent

Intervention groups

1

Description
second group: in second group (10 patients) use Orthokin toothpaste (containing CHX and Zinc) for 2 weeks.
Category
Treatment - Drugs

2

Description
third group:10 patients use Kin-gingival toothpaste (containing CHX ) for 2 weeks.
Category
Treatment - Drugs

3

Description
first group: 10 patients use anticavity Crest toothpaste for 14 dayes as control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kerman Social Determinants on Oral Health Research Center AND Department of Periodontics, School of
Full name of responsible person
Street address
City
kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
besat research center, Kerman univercity of medical sciences
Full name of responsible person
mohadeseh arabsolghar
Street address
kerman
City
kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
besat research center, Kerman univercity of medical sciences
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
Department of Periodontology, School of Dentistry, Kerman University of Medical Sciences. Kerman, Ir
Full name of responsible person
Mohadeseh Arabsolghar
Position
Assistant Professor
Other areas of specialty/work
Street address
Kerman University of Medical Sciences,Shafa Avenue, Kerman, Iran
City
kerman
Postal code
Phone
+34 2478571
Fax
Email
m.a.solghar@kmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Periodontology, School of Dentistry, Kerman University of Medical Sciences
Full name of responsible person
mohadeseh arabsolghar
Position
Assistant Professor
Other areas of specialty/work
Street address
Kerman University of Medical Sciences,Shafa Avenue, Kerman, Iran.
City
kerman
Postal code
Phone
+34 32478571
Fax
Email
m.a.arabsolghar@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Periodontology, School of Dentistry, Kerman University of Medical Sciences
Full name of responsible person
Mohadeseh Arabsolghar
Position
assistant professor
Other areas of specialty/work
Street address
Kerman University of Medical Sciences,Shafa Avenue, Kerman, Iran
City
Kerman
Postal code
Phone
+98 34 3211 9022
Fax
Email
m_arab_s@yahoo.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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