This study will be done with aim to investigate the effectiveness of using topical clindamycin nanoparticles gel in the prevention of alveolar osteitis. This study is a double blind clinical trial. The study population will be consisted of patients referred to oral and maxillofacial surgery of Dental School of Kermanshah. 302 patients randomly will be selected and will be divided into control and experimental groups. Baseline alveolar osteitis incidence rates in both groups will be measured. Then in the experimental group after pulling teeth, treatment with clindamycin gel tube will be done. In the control group routine treatment includes treatment with gel tube without antibiotics will be done. In the third and seventh days after pulling teeth incidence and no incidence rates of alveolar osteitis in both groups will be compared.
Inclusion criteria: Patients needing tooth extractions; Age between 18 and 68
Exclusion criteria: Hypersensitivity to clindamycin; Antibiotic therapy within the past three months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021214333N67
Registration date:2017-04-08, 1396/01/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-08, 1396/01/19
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-02-28, 1395/12/10
Expected recruitment end date
2017-09-01, 1396/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effectiveness of using topical clindamycin nanoparticles gel in the prevention of alveolar osteitis
Public title
Evaluation of the effect of topical clindamycin in prevention of alveolar osteitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients needing tooth extractions; Age between 18 and 64
Exclusion criteria: Hypersensitivity to clindamycin; Antibiotic therapy within the past three months.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly by tossing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2016-12-14, 1395/09/24
Ethics committee reference number
kums.rec.1395.534
Health conditions studied
1
Description of health condition studied
Dry socket
ICD-10 code
k10.3
ICD-10 code description
Alveolitis of jaws
Primary outcomes
1
Description
Alveolar osteitis incidence
Timepoint
Baseline, third and seventh days after tooth extraction
Method of measurement
Based on the observation by doctor
Secondary outcomes
empty
Intervention groups
1
Description
in the Intervention group treatment with clindamycin gel tube will be done
Category
Treatment - Drugs
2
Description
In the control group routine treatment includes treatment with gel tube without antibiotics will be done
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of dentistry
Full name of responsible person
Saeed Niazi
Street address
School of dentistry, Shariati Street
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Saeed Niazi
Position
Student of dentistry
Other areas of specialty/work
Street address
School of dentistry, Shariati Street
City
Kermanshah
Postal code
Phone
+98 83 3721 8209
Fax
Email
niazi_saeed_1992@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hesamedin Nazari
Position
Specialist Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
School of dentistry, Shariati Street
City
Kermanshah
Postal code
Phone
+98 83 3722 2400
Fax
Email
Hesamedin_nazari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Saeed Niazi
Position
Student of dentistry
Other areas of specialty/work
Street address
Student of dentistry
City
Kermanshah
Postal code
Phone
+98 83 3721 8209
Fax
Email
niazi_saeed_1992@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)