The aim of this study is investigating clinical and microbiological effects of subgingival use of an antiviral drug on 18 clinically healthy patients with chronic periodontitis. Patients who have been received antibiotic therapy during 3 months prior to study or periodontal therapy during 6 months prior to study and pregnant or breast fed patients were excluded. 2 teeth with pocket depth 5mm or more were chosen in each patient and put randomly in intervention or control group. In intervention group SRP+2.5% subgingival Acyclovir gel and in control group SRP alone were done. Clinical parameters (pocket depth, clinical attachment level, gingival index, BOP) and sub gingival plaque sampling (P.Gingivalis count) were measured at baseline, 1 month & 3 months after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138801231809N1
Registration date:2009-07-25, 1388/05/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-07-25, 1388/05/03
Registrant information
Name
Kobra Vasegh
Name of organization / entity
Dental school, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3550
Email address
vaseghk@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences & Personal sources
Expected recruitment start date
2008-04-05, 1387/01/17
Expected recruitment end date
2008-05-09, 1387/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Subgingival Use of 2/5% Acyclovir Gel on Clinical and Microbiological parameters in Chronic periodontitis
Public title
Clinical and Microbiological Effects of 2/5% Acyclovir Gel
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of chronic periodontitis, presence of at least 2 pockets with 5 mm pocket depth
Exclusion criteria: Presence of any systemic disease, periodontal treatment during 6 month prior to study, antibiotic use during 3 months prior to study, Smoking, Pregnancy, or breast feeding
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand street.
City
Shiraz
Postal code
Approval date
2008-10-18, 1387/07/27
Ethics committee reference number
ct-87-4244
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
P. Gingivalis Count
Timepoint
Baseline (Before Treatment), 1 & 3 months after treatment
Method of measurement
Mycrobiological Analysis ( Culture & PCR)
2
Description
Clinical Attachment Level
Timepoint
Baseline (Before Treatment), 1 & 3 month after treatment
Method of measurement
Clinical Evaluations
3
Description
Pocket Depth
Timepoint
Baseline (Before Treatment), 1 & 3 months after treatment
Method of measurement
Clinical Evaluations (Probing)
4
Description
Gingival Index
Timepoint
Baseline (Before Treatment), 1 & 3 month after treatment
Method of measurement
Clinical Evaluations
5
Description
Bleeding On Probing
Timepoint
Baseline (Before Treatment), 1 & 3 month after treatment
Method of measurement
Clinical Evaluations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Supra and Subgingival scaling and rootplaning (hand & ultrasonic instrumentents)+2.5% subgingival acyclovir gel (by an end cut syringe which was put in pocket)
Category
Treatment - Drugs
2
Description
Control group: Supra and Subgingival scaling and root planing (hand & ultrasonic instrumentents)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontics Department, Dental School, Shiraz University of Medical Sciences
Full name of responsible person
Dr.Kobra vasegh
Street address
Dental School, Shiraz University of Medical Sciences
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental School, Shiraz University of Medical Sciences
Full name of responsible person
Dr.Postforosh
Street address
Central Building of Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental School, Shiraz University 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
Full name of responsible person
Dr. Kobra vasegh
Position
Periodontist
Other areas of specialty/work
Street address
No 2, Ravansar Alley, Tavanir street, Valie asr St.
City
Tehran
Postal code
Phone
+98 21 8877 3550
Fax
+98 21 8877 3550
Email
vaseghk@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental School, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Hengame Khosropanah
Position
Assistant Professor
Other areas of specialty/work
Street address
Periodontics Department,Dental School
City
Shiraz
Postal code
Phone
+98 71 1229 3497
Fax
+98 71 1229 3497
Email
khosropanah.979@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr. Kobra Vasegh
Position
Periodontist
Other areas of specialty/work
Street address
No 2, Ravansar Alley, Tavanir st., Valie asr St., Tehran
City
Tehran
Postal code
Phone
+98 21 8877 3550
Fax
+98 21 8877 3550
Email
vaseghk@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)