Evaluation and comparision of surgical outcomes of frenectomy in infants with ankyloglossia using electrocoutery or surgical in Tabriz pedriatric hospital
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General information
60
40
6040
empty
Reducing the number of samples from 60 to 40. Due to the conditions and the spread of Covid-19
Reducing the number of samples from 60 to 40. Due to the conditions and the spread of Covid-19
empty
کاهش تعداد نمونه از 60 به 40. به جهت شرایط و شیوع کرونا
کاهش تعداد نمونه از 60 به 40. به جهت شرایط و شیوع کرونا
Protocol summary
Study aim
Determination of complications of phrynctomy (bleeding, infection, movement limitation and tongue dysfunction) in neonates with ankylosing spondylitis using electrocautery and incision surgery
Design
Clinical trial with control group, with parallel, non-blind, simple randomized groups, on 20 patients. Excel software rand function was used for randomization.
Settings and conduct
Sampling is done after receiving the code of ethics from the university ethics committee. Patients will be randomly selected from patients referred to the ENT surgery clinic of Tabriz Children's Hospital. Diagnosis is by clinical examination and parental history. Patients will be selected based on the criteria of admission (parental consent and definitive diagnosis with history and clinical examination) and exclusion (unwillingness to continue treatment at any stage) and will be randomly divided into one of two groups A and B.
Participants/Inclusion and exclusion criteria
Age 6 months to 2 years; No previous procedure for ankyloglossia; Acceptance of research terms and procedures by parents; Lack of effective oral and tongue disease in the study results; Diagnosis of Ankyloglossia
Intervention groups
Intervention group: Using electrocautery (instead of surgery) for tongue phrenctomy. This method is safer and faster and has fewer complications Control group: Patients in this group undergo traditional surgical phrentomy.
Main outcome variables
Freedom of tongue movement in the mouth; Improves infant feeding
General information
Reason for update
Reducing the number of samples from 60 to 40. Due to the conditions and the spread of Covid-19
Acronym
فرنولوم زبان
IRCT registration information
IRCT registration number:IRCT20150114020663N7
Registration date:2021-10-31, 1400/08/09
Registration timing:prospective
Last update:2022-12-25, 1401/10/04
Update count:1
Registration date
2021-10-31, 1400/08/09
Registrant information
Name
Davoud Badebarin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2257
Email address
badebarind@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparision of surgical outcomes of frenectomy in infants with ankyloglossia using electrocoutery or surgical in Tabriz pedriatric hospital
Public title
Evaluation and comparision of surgical outcomes and complications of frenectomy in infants with ankyloglossia using electrocoutery or surgical in Tabriz pedriatric hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age6 months to 2 years
No previous procedure for ankyloglossia
Acceptance of research terms and procedures by parents
Lack of effective oral and tongue disease in the study results
Diagnosis of Ankyloglossia
Exclusion criteria:
Age above 2 years
Previous surgery on the tongue
Severe adhesion of the tongue to the floor of the mouth
Another severe underlying disease
Age
From 6 months old to 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to intervention and control groups. Patients are distributed in two groups (random sequence) using a table of random numbers. Patients are divided between the two groups by announcing the number of patients in the clinic. Odd numbers in one group and even numbers in the second group. Patients are selected in the clinic of Tabriz Children's Hospital
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences., Golgasht St., Azadi St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-10-04, 1400/07/12
Ethics committee reference number
IR.TBZMED.REC1400.634
Health conditions studied
1
Description of health condition studied
Ankyloglossia
ICD-10 code
Q38.1
ICD-10 code description
Ankyloglossia
Primary outcomes
1
Description
Answer to surgical or electrocautery treatment of the tongue ferronolum
Timepoint
6 months
Method of measurement
Physical examination
Secondary outcomes
1
Description
Good baby nutrition
Timepoint
6month and 1 year
Method of measurement
Weighing
Intervention groups
1
Description
Intervention group: Electrocautery. In this group of patients, the patient's tongue follicle is removed using the cauterization device in the operating room of Tabriz Children's Hospital. The cutter degree is set to cut 8. The incision is performed by the surgeon in one session and after the end of the work, the patient is monitored for recovery from bleeding under the tongue and edema.
Category
Treatment - Surgery
2
Description
Control group: surgery. In this group, patients undergo tongue follicle resection by traditional surgical method after general anesthesia using anesthesia and restoration with 0.4 vicryl suture. It is controlled for bleeding under the tongue and edema.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Childeren Hospital
Full name of responsible person
Davoud Badebarin
Street address
ِDaneshgah Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165678691
Phone
+98 41 3526 2257
Email
badebarind@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Deputy of Research and Technology, Central Building of Number Two, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5165678691
Phone
+98 41 3336 3767
Email
badebarind@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Davoud Badebarin
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Surgeon
Street address
Medical Faculty, Adjacent to the Emam Reza hospital, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165678691
Phone
+98 41 3526 2257
Fax
+98 41 3526 2279
Email
badebarind@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Davoud Badebarin
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Surgeon
Street address
Medical Faculty, Adjacent to the Emam Reza hospital, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165678691
Phone
+98 41 3526 2257
Fax
+98 41 3526 2279
Email
badebarind@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Davoud Badebarin
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Medical Faculty, Adjacent to the Emam Reza hospital, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165678691
Phone
+98 41 3526 2257
Fax
+98 41 3526 2279
Email
badebarind@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD