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Trial registered on ANZCTR


Registration number
ACTRN12618002000280
Ethics application status
Approved
Date submitted
3/12/2018
Date registered
13/12/2018
Date last updated
13/12/2018
Date data sharing statement initially provided
13/12/2018
Date results information initially provided
13/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nasal Functions of Operated Unilateral Cleft Lip and Palate Patients Compared with Skeletal Class III Individuals
Scientific title
Nasal Functions of Operated Unilateral Cleft Lip and Palate Patients Compared with Skeletal Class III Individuals
Secondary ID [1] 296765 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cleft Lip-Palate 310650 0
Alveolar Cleft 310686 0
Condition category
Condition code
Oral and Gastrointestinal 309362 309362 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Respiratory 309363 309363 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Hours
Description of intervention(s) / exposure
The nasal resistance data were collected with anterior rhinomanometry method for unilateral Cleft Lip and Palate patients (study group) at least 6 months after the surgical procedure and also for control group. Anterior Rhinomanometry (RM) is a non-invasive dynamic test showing nasal airflow resistance with two tubes placed at the nostrils, is widely used to evaluate the expiration and resistance of the upper airways objectively and quantitatively.
Before evaluation, the patients who rested in the upright position for 20 minutes. For removing the mucosal congestion because of ‘nasal cycle phenomenon’, nasal decongestant spray was applied to both nostrils and waited for 15 minutes. Nasal airflow was measured (in ml/sec) by active anterior rhinomanometry at the pressure of 150 Pa for each nostril separately, during five repetitive hard inspiration and expiration. The nasal resistance for nasal sides and total nasal resistance were measured in Pa/L/sec.
Intervention code [1] 313075 0
Early Detection / Screening
Comparator / control treatment
The control group included individuals had the healthy and non-cleft skeletal class III control group participants corresponded in age and sex to the study group
Control group
Active

Outcomes
Primary outcome [1] 308319 0
Comparison of the study group and the control group in terms of nasal resistance that were collected with Anterior Rhinomanometry method
Timepoint [1] 308319 0
At least post-operative 6 months
Secondary outcome [1] 354604 0
Nil
Timepoint [1] 354604 0
Nil

Eligibility
Key inclusion criteria
Non-syndromic cleft lip and palate patients with cleft lip reconstruction, cleft palate repair surgery, and alveolar cleft grafting surgery were completed and at least 6 months after the last surgery.
The control group included skeletal class III individuals corresponded in age and sex to the patients of study group individually
Minimum age
10 Years
Maximum age
21 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria for both study and control groups were acute or chronic upper airway infections, nasal or orthognathic surgery history, any syndrome or craniofacial anomaly, surgical or not palatal expansion history, or pharyngeal and nasal pathologies such as tonsillitis or polyposis, and smokers.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Statistical analysis was performed using SPSS 20.0 software. For normality tests, Kolmogorov-Smirnov test was used. For determining the differences between the groups, the Student t test and Mann Whitney U test were used. P values of “<0.05” were considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21093 0
Turkey
State/province [1] 21093 0
Erzurum

Funding & Sponsors
Funding source category [1] 301343 0
University
Name [1] 301343 0
Ataturk University
Address [1] 301343 0
Atatürk University Faculty of Dentistry Department of Oral and Maxillofacial Surgery
Main Campus of Ataturk University, 25040 Yakutiye, ERZURUM
Country [1] 301343 0
Turkey
Primary sponsor type
University
Name
Ataturk University
Address
Atatürk University Faculty of Dentistry Department of Oral and Maxillofacial Surgery
Main Campus of Ataturk University, 25040 Yakutiye, ERZURUM
Country
Turkey
Secondary sponsor category [1] 301011 0
None
Name [1] 301011 0
Address [1] 301011 0
Country [1] 301011 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302082 0
Regional Ethical Review Board of Ataturk University Faculty of Dentistry
Ethics committee address [1] 302082 0
Ataturk University Faculty of Dentistry, 25040 Yakutiye, Erzurum
Ethics committee country [1] 302082 0
Turkey
Date submitted for ethics approval [1] 302082 0
09/03/2016
Approval date [1] 302082 0
13/06/2016
Ethics approval number [1] 302082 0
16/084

Summary
Brief summary
The purpose of this study was to measure the nasal airflow resistance of UCLP (Unilateral Cleft Lip and Palate) patients with anterior rhinomanometry method compared with individuals with non-cleft skeletal class III serving as the control group. For 16 operated UCLP patients and 16 healthy skeletal class III participants corresponded in age and sex to the study group were included this prospective study. For both UCLP and control groups, the nasal resistance data were collected with anterior rhinomanometry. Nasal airflow was measured (in ml/sec) at the pressure of 150 Pa for each nostril separately. To evaluation of nasal side subgroups of UCLP group for nasal resistance, the cleft sides and non-cleft sides of individuals were examined in two separate groups. The nasal side resistance of control group was evaluated as the average of both nasal side resistances. The nasal resistance for nasal sides and total nasal resistance were measured in Pa/L/sec. The observed data analyzed using appropriate statistical methods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89066 0
Dr Mert Ataol
Address 89066 0
Mersin University Faculty of Dentistry Department of Oral and Maxillofacial Surgery
Çiftlikköy Campus, 33343, Yenisehir, MERSIN
Country 89066 0
Turkey
Phone 89066 0
+905333686222
Fax 89066 0
Email 89066 0
ataolmert@gmail.com
Contact person for public queries
Name 89067 0
Dr Mert Ataol
Address 89067 0
Mersin University Faculty of Dentistry Department of Oral and Maxillofacial Surgery
Çiftlikköy Campus, 33343, Yenisehir, MERSIN
Country 89067 0
Turkey
Phone 89067 0
+905333686222
Fax 89067 0
Email 89067 0
ataolmert@gmail.com
Contact person for scientific queries
Name 89068 0
Dr Mert Ataol
Address 89068 0
Mersin University Faculty of Dentistry Department of Oral and Maxillofacial Surgery
Çiftlikköy Campus, 33343, Yenisehir, MERSIN
Country 89068 0
Turkey
Phone 89068 0
+905333686222
Fax 89068 0
Email 89068 0
ataolmert@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
How or where can data be obtained?
unrestricted access
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 591 0
Thesis/dissertation
Citation/DOI/link/details [1] 591 0
Ataturk University Health Science Thesis Archieve
Attachments [1] 591 0
Results – basic reporting
Results – plain English summary
The present study sample consisted of 16 patients with Unilateral Cleft Lip and Palate (UCLP) and 16 non-Cleft control group individuals. The results showed that there were no differences between the UCLP and control groups in terms of age and sex. In terms of total nasal resistance, it was shown that the UCLP group data had statistically significantly higher nasal resistance than the control group for both inspiration and expiration. Three subgroups compared based on nasal side resistances for both inspiration and expiration. The nasal side resistance of control group showed statistically significantly superior results compared with the cleft sides and non-cleft sides of UCLP group during inspiration and expiration. On the other hand, there was no statistically significant difference between the nasal resistance of the cleft side and the non-cleft side of the UCLP individuals during the inspiration and expiration.