Nasal Functions of Operated Unilateral Cleft Lip and Palate Patients Compared with Skeletal Class III Individuals

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12618002000280

Enrollment

Registered

2018-12-13

Start date

2016-09-01

Completion date

2017-06-30

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

All

Age

10 Years to 21 Years

Healthy volunteers

Yes

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

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.

Outcome results