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Comparison of the effect of low dose doxycycline(20mg capsule) and licorice(490mg tablet) as adjunctive therapy in chronic periodontitis

Protocol summary

Summary
Aim of the study:Comparison of the effect of low dose doxycycline(20mg capsule) and licorice(490mg tablet) as adjunctive therapy in chronic periodontitis. Randomized, single blind, controlled with placebo, single center. A total of 45 patients with mild to moderate chronic periodontitis. Inclusion criteria: Physically healthy patients, 25-45 years old and with plaque index under 30%. exclusion criteria: The patients with systemic diseases, pregnant and lactescent women,the patients receiving each drug or antibiotic during 6 months ago, sensitivity to kinds of antibiotic, the patients who had scaling or gum surgery and smokers. After Oral hygiene education to three groups, A 20mg doxycycline capsule was prescribed and given to each patient in the first group daily, the second group was prescribed and given a 490mg licorice tablet per day, and the third group as control group was prescribed and given a placebo capsule per day. The time of intervention was 6 weeks. The primary outcomes: Plaque Index(PI), Pocket Depth(PD), Clinical Attachment Loss(CAL), Bleedig On Probing(BOP).

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2014041217228N1
Registration date: 2014-05-10, 1393/02/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-10, 1393/02/20
Registrant information
Name
Tahmures Mahmudpourmoteshakker
Name of organization / entity
Dentistry school of Islamic Azad University Isfahan branch(Khorasgan)
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4001
Email address
t.mahmudpour@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Research ministry of dentistry school of Islamic Azad University, Isfahan branch (Khorasgan)
Expected recruitment start date
2013-12-06, 1392/09/15
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of low dose doxycycline(20mg capsule) and licorice(490mg tablet) as adjunctive therapy in chronic periodontitis
Public title
The effect of licorice(490mg tablet) in treatment of chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients with mild to moderate chronic periodontitis, physically healthy, 25-45 years old and the plaque index under 30% exclusion criteria: The patients with systemic diseases, pregnant and lactescent women,the patients receiving each drug or antibiotic during 6 months ago, sensitivity to kinds of antibiotic, the patients who had scaling or gum surgery and smokers.
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University of Medical Sciences and hygienic- treatment services of Isfahan province
Street address
Hezarjarib st, Isfahan.
City
Isfahan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Approval date
2013-12-02, 1392/09/11
Ethics committee reference number
493008

Health conditions studied

1

Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis

Primary outcomes

1

Description
Pocket depth(pathologic sulcus of gingiva)
Timepoint
6 weeks after the beginning of intervention
Method of measurement
periodontal probe

2

Description
Clinical attachment loss
Timepoint
6 weeks after the beginning of intervention
Method of measurement
periodontal probe

3

Description
Bleeding on probing
Timepoint
6 weeks after the beginning of intervention
Method of measurement
Muhlemann index, periodontal probe

Secondary outcomes

1

Description
Plaque Index
Timepoint
beginning of recruitment
Method of measurement
O'leary Index, disclosing tablet

Intervention groups

1

Description
First group(intervention group): Low dose doxycycline(20mg capsule)
Category
Treatment - Drugs

2

Description
Second group(Intervention group): Licorice(490mg tablet)
Category
Treatment - Drugs

3

Description
Third group( control group): Placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dentistry school of Islamic Azad University Isfahan branch(Khorasgan)
Full name of responsible person
Tahmures Mahmudpourmoteshakker(dentistry student)
Street address
Daneshgah blvd, Arghavanieh, East jey st, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research ministry of dentistry school of Islamc Azad University, Isfahan branch(Khorasgan)
Full name of responsible person
Dr Vahid Esfahanian
Street address
Daneshgah blvd, Arghavanieh, East jey st, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research ministry of dentistry school of Islamc Azad University, Isfahan branch(Khorasgan)
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
Dentistry school of Islamic Azad University Isfahan branch(Khorasgan)
Full name of responsible person
Tahmures Mahmudpourmoteshakker
Position
Dentistry student
Other areas of specialty/work
Street address
Daneshgah blvd, Arghavanieh, East jey st, Isfahan
City
Isfahan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Phone
+98 31 1535 4001
Fax
+98 31 1535 4060
Email
T.Mahmudpour@yahoo.com
Web page address
khuisf.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dentistry school of Islamic Azad University Isfahan branch(Khorasgan)
Full name of responsible person
Tahmures Mahmudpourmoteshakker
Position
Dentistry student
Other areas of specialty/work
Street address
Daneshgah blvd, Arghavanieh, East jey st, Isfahan
City
Isfahan
Postal code
8155139998
Phone
+98 31 1535 4001
Fax
+98 31 1535 4060
Email
t.mahmudpour@yahoo.com
Web page address
khuisf.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Dentistry school of Islamic Azad University Isfahan branch(Khorasgan)
Full name of responsible person
Tahmures Mahmudpourmoteshakker
Position
Dentistry student
Other areas of specialty/work
Street address
Daneshgah blvd, Arghavanieh, East jey st, Isfahan
City
Isfahan
Postal code
۸۱۵۵۱۳۹۹۹۸
Phone
+98 31 1535 4001
Fax
+98 31 1535 4060
Email
T.mahmudpour@yahoo.com
Web page address
www.khuisf.ac.ir

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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