Comparison between Conventional Surgical Drainage and Drainage with Catheter under Ultrasonographic Guide in Odontogenic Infections of Submandibular and Ptrygomandibular Space Abscesses
Purpose: The aim of this study is to compare the quality, advantages and disadvantages of two treatment methods: drainage with surgery and Ultrasound-guided drainage with catheter. Patients and Method: 30 patients with Submandibular or Ptrygomandibular space abscesses randomly are divided in two groups. In group 1, 15 patients will be treated by catheter and Ultrasonography and other 15 patients in group 2, will be treated with surgery. Treatment and drainage successfulness, pain during drainage and irrigation, existence scar after 3 months and duration of hospitalization, will be measured in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711301704N1
Registration date:2009-03-21, 1388/01/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-03-21, 1388/01/01
Registrant information
Name
Mohsen Abbasi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2237 6198
Email address
mnabbasi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center, dental school, Tehran university of medical sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Conventional Surgical Drainage and Drainage with Catheter under Ultrasonographic Guide in Odontogenic Infections of Submandibular and Ptrygomandibular Space Abscesses
Public title
Comparison between two methods for treatment of odontogenic infections
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: submandibular and ptrygomandibular space odontogenic abscesses. Exclusion criteria: multiple spaces, uncontrolled or severe systemic diseases.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is the first time that two treatment methods are compared
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical sciences
Street address
Ghods Ave, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2009-01-07, 1387/10/18
Ethics committee reference number
8050-70-04-87
Health conditions studied
1
Description of health condition studied
odontogenic infections
ICD-10 code
K00-K14
ICD-10 code description
Diseases of oral cavity, salivary glands and jaws
Primary outcomes
1
Description
treatment successfulness
Timepoint
48 hours and 1 week post op
Method of measurement
objective and subjective signs and symptoms, lab tests WBC, ESR/CRP
2
Description
pain during drainage and irrigation
Timepoint
immediately post op
Method of measurement
visual analogue pain scale
Secondary outcomes
1
Description
scar
Timepoint
3 months post op
Method of measurement
inspection
2
Description
duration of hospitalization
Timepoint
duration of hospitalization to discharge
Method of measurement
days from admission to discharge
Intervention groups
1
Description
Group1: abscess drainage with catheter under ultrasonographic guide
Category
Treatment - Surgery
2
Description
Group2: abscess drainage with conventional incision/drainage
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and maxillofacial departement, Shariati hospital
Full name of responsible person
Mohsen Abbasi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Dr Masood Younesian
Street address
Ghods Ave. Keshavarz Blvd.
City
Tehran
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 of Tehran 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
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Mrs Aslanpoor
Position
expert in research
Other areas of specialty/work
Street address
Ghods Ave. Keshavarz blvd
City
Tehran
Postal code
Phone
+98 21 8163 3614
Fax
Email
resdeputy@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical sciences, Dental school
Full name of responsible person
Dr Mohammad Bayat
Position
Associate Professor
Other areas of specialty/work
Street address
Oral & maxillofacial surgery Dep., Shariati hospital
City
Tehran
Postal code
Phone
+98 21 8490 2473
Fax
Email
mbayat2000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Mrs Aslanpoor
Position
expert in research
Other areas of specialty/work
Street address
Ghods Ave, Keshavarz blvd
City
Tehran
Postal code
Phone
+98 21 8163 3614
Fax
Email
resdeputy@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)