Protocol summary

Summary
Objective: Evaluation of the effect of therapeutic topical Metronidazole gel Piroxicam with piroxicam in chronic periodontitis Methods & Material : In this study, 24 patients with chronic periodontitis disease that has the molar teeth on edither sides with periodontal pocket depth of 4-6 mm, And then scaling & rootplaning and oral hygiene instruction (Bass technique of brushing twice a day and at least 2 min) was performed, After 2 weeks, Patients in the study, were randomly divided into 2 groups (Balanced block randomization), All periodontal parameters evaluated prior to the start of treatment, the experimental group: Piroxicam (5 %) plus Metronidazole (7.5%) and Piroxicam groups: with an insulin syringe is placed into the periodontal pocket, Every 15 days once periodontal parameters were assessed, and at the end of the study evaluated the clinical parameters.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014050817587N3
Registration date: 2014-06-26, 1393/04/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-06-26, 1393/04/05
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
Invistigator
Expected recruitment start date
2013-01-14, 1391/10/25
Expected recruitment end date
2014-04-09, 1393/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of a topical piroxicom plus metronidazole gel and piroxicom gel in treatment for pockets in chronic periodontal Disease.
Public title
A double-blind, Randomized, Controlled trial comparison of a topical piroxicom plus metronidazole gel and Piroxicom gel in Treatment for Periodontal disease.
Purpose
Treatment
Inclusion/Exclusion criteria
All of the Patients following criteria were included in the study: aged between 30 and 45 years; 20 natural teeth present; Probing depth (PD) of 4-6 mm) Patients were Excluded from the Study if they met one or more of the Following criteria: Existing systemic disease that may influence the severity or progression of periodontitis, or Diabetes Mellitus; Taking medications that may influence the periodontium (e.g. Phenytoin, ... or Non-steroidal anti-Inflammatory drugs) or other medicines (Antibiotic) within the 6 months preceding the beginning of the study, Orthodontic treatments; Extensive dental restorations, Pregnancy or Lactation; Non-agreement with the examination and treatment appointments; Mouthrinses, During the entire period of the Study; Hypersensitive to these medicine; Smoking
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 20
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
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
2011-08-20, 1390/05/29
Ethics committee reference number
2126

Health conditions studied

1

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

Primary outcomes

1

Description
Pocket depth
Timepoint
Reduction of Pocket depth
Method of measurement
Periodontal probe

2

Description
Clinical attachment level
Timepoint
15 days
Method of measurement
Periodontal probe

Secondary outcomes

1

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

2

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

Intervention groups

1

Description
piroxicam ( 5 percent made of Razak Pharmaceutical Co -Iran ) plus metronidazole (7.5%) (made of Pars Pharmaceutical Co-Iran ) with an insulin syringe is placed into the periodontal pocket.
Category
Treatment - Drugs

2

Description
Piroxicam gel ( 5 percent made of Razak Co-Iran ) with an insulin syringe is placed into the periodontal pocket.
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 of Tehran
Full name of responsible person
Amirhossein Farahmand
Position
Periodontologist, Implantologist
Other areas of specialty/work
Street address
No 4, 10th Neyestan Allley, 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
empty
Analytic Code
empty
Data Dictionary
empty
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