Protocol summary

Summary
Study design: randomized clinical trial. Inclusion criteria: patients upper than 18 years old referred to Besat Hospital clinic with chronic tonsillitis with caseum who had symptoms such as halitosis(with positive Finklestien smell test ) or feeling of foreign body and chronic irritation of tonsils; patients who had no periodontal disease, gingivitis or other systemic disease that result in halitosis such as hepatorenal and pulmonary and gastroenterological disease or diabetes mellitus , sinusitis, nasopharyngeal , oropharyngeal or laryngeal cancer in history and physical examination; patients who had no contraindications for radiofrequency of tonsils such as having cardiac pace maker, immunodeficiency disease or coagulation disorders and patients who had no limitation for CO₂- laser. cryptolysis such as anatomical orophryngeal anomalies or mallampati grading 3 or 4. Sample size: 50. Study objective: finding a safe and more cost-effective way to treat chronic tonsillitis with caseum

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201303233186N3
Registration date: 2013-08-23, 1392/06/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-08-23, 1392/06/01
Registrant information
Name
Farnaz Hashemian
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 9001
Email address
hashemian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing temperature _ controlled radiofrequency tonsil ablation and CO₂- laser cryptolysis on treatment of chronic tonsillitis with caseum.
Public title
Assessing temperature _ controlled radiofrequency tonsil ablation and CO₂- laser cryptolysis on treatment of chronic tonsillitis with caseum.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients upper than 18 years old referred to Besat Hospital clinic with chronic tonsillitis with caseum who had symptoms such as halitosis(with positive Finklestien smell test ) or feeling of foreign body and chronic irritation of tonsils; patients who had no periodontal disease, gingivitis or other systemic disease that result in halitosis such as hepatorenal and pulmonary and gastroenterological disease or diabetes mellitus , sinusitis, nasopharyngeal , oropharyngeal or laryngeal cancer in history and physical examination; patients who had no contraindications for radiofrequency of tonsils such as having cardiac pace maker, immunodeficiency disease or coagulation disorders and patients who had no limitation for CO₂- laser. Exclusion criterion: cryptolysis such as anatomical orophryngeal anomalies or mallampati grading 3 or 4.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
None
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamedan university of medical
Street address
Hamedan university of medical sciences,Shahid Fahmideh street,Hamedan.
City
Hamedan
Country
Iran (Islamic Republic of)
Postal code
65178
Approval date
2013-04-08, 1392/01/19
Ethics committee reference number
16/35/9/63/پ/د

Health conditions studied

1

Description of health condition studied
Chronic tonsillitis with caseum
ICD-10 code
J35
ICD-10 code description
Chronic tonsillitis

Primary outcomes

1

Description
Halitosis
Timepoint
Before, 1 week, 1 month, 6 months after intervention
Method of measurement
Visual analog scale questionnaire

2

Description
Feeling of foreign body
Timepoint
Before, 1 week, 1 month,6 months after intervention
Method of measurement
Visual analog scale questionnaire

Secondary outcomes

1

Description
Post intervension pain
Timepoint
1, 3 and 7 days after intervension
Method of measurement
Visual analog scale

Intervention groups

1

Description
Intervention : temperature _ controlled radiofrequency tonsil ablation
Category
Treatment - Other

2

Description
Control : CO₂- laser cryptolysis of tonsils
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat hospital, ENT clinic
Full name of responsible person
Street address
City
Hamedan
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Tavilani Heydar
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh street, Hamedan
City
Hamedan
Country
Iran (Islamic Republic of)
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Farnaz Hashemian
Position
Associate professor
Other areas of specialty/work
Street address
Besat hospital, shahid Beheshti Blvd., Hamedan
City
Hamedan
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 81 1264 0047
Fax
Email
hashemian@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farnaz Hashemian
Position
Associate professor
Other areas of specialty/work
Street address
Besat hospital,shahid Beheshti Blvd., Hamedan
City
Hamedan
Country
Iran (Islamic Republic of)
Postal code
65178
Phone
+98 81 1264 0047
Fax
Email
hashemian@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farnaz Hashemian
Position
Associate professor
Other areas of specialty/work
Street address
Besat hospital, Shahid Beheshti Blvd., Hamedan.
City
Hamedan
Country
Iran (Islamic Republic of)
Postal code
65178
Phone
+98 81 1264 0047
Fax
Email
hashemian@umsha.ac.ir
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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