Objectives: The aim of the present clinical study was to evaluate the efficacy of doxycyline 3% plus ketoprofen 2.5% as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
Material and Methods: 20 systemically healthy, chronic periodontitis patients were included in the study.The Patients were selected on the basis of having chronic periodontitis with periodontal pocket depths of more than 4mm on at least two teeth in mandibular molar area; Periodontal parameters (plaque, bleeding on probing and pocket depth) were recorded at baseline and every 15 days for 3 months. Oral hygiene instructions were given that included brushing twice- daily, (Using the Bass brushing technique for at least 2 minutes ), Randomly divided two groups,Test group: was treated by scaling and root planing Followed by local delivery of doxycycline 3%+ ketoprofen 2.5%, While the control group: was treated by scaling and root planing along with ketoprofen 2.5%; and was administered to the both groups every 15 days for 3 months, repeated. Every 15 days once periodontal parameters were assessed, and at the end of 3 months, evaluated the clinical parameters changes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050717587N2
Registration date:2014-06-23, 1393/04/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-23, 1393/04/02
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
2012-06-16, 1391/03/27
Expected recruitment end date
2013-07-13, 1392/04/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of subgingivally delivered Doxycycline plus ketoprofen gel as an adjunct to non-surgical treatment of chronic Periodontitis
Public title
Randomized, double blind, placebo controlled clinical trial of compare with Doxycycline plus ketoprofen gel in Chronic Periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: adult patients, older than 18 years old, systemically healthy, and having at least 20 teeth. Exclusion criteria: patients with cavitated caries, no periodontal pockets larger than 4 mm, orthodontic appliances or removable prostheses, allergies to cetylpyridinium or CHX, use of antibiotics and anti-inflammatory drugs in the past 3 months that might alter normal gingival health, oral prophylaxis outside of study; use of oral chlorhexidine products or participation in an oral rinse study within 3 months prior to baseline examination, pregnancy or lactation, smoking.
Age
From 30 years old to 45 years old
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
For the First time ever
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Dental Branch Islamic Azad Univesity of Tehran
ketoprofen gel ( 2.5% Sanofi Pharmaceutical plant construction in France ) + 3 % doxycycline (Kharzmai Pharmaceutical manufacture in Iran ) which be put into the periodontal pocket using an insulin syringe.
Category
Treatment - Drugs
2
Description
ketoprofen gel ( 2.5% Sanofi Pharmaceutical plant construction in France), which be inserted into the periodontal pocket using an insulin syringe .
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, 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