Mordified Restoration of Tensor Veli Palatini in Cleft Palate Repair

The Possible Effect of Modified Restoration of Tensor Veli Palatini on Audiological and Otological Outcome in Cleft Palate Repair.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04366674

Enrollment

Registered

2020-04-29

Start date

2013-01-01

Completion date

2019-06-30

Last updated

2020-04-29

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

Conditions

Cleft Palate

Brief summary

to study the benefical audiological and/or otological effect by mordified restoration of tensor veli palatini in cleft palate repair compared to traditional Langenbeck's repair and merely levator veli palatini restoration.

Detailed description

71 patients with cleft palate received surgery were divided into 3 groups. Group 1: patients who received Langenbeck surgery without specific restoration of levator veli palatini or tensor veli palatini. Group 2: patients who received palate surgery with special levator veli palatini restoration. Group 3: patients who received palate surgery with modified tensor veli palatini restoration. The conductive auditory brainstem response and 226 Hz tympanometry were used to test the audiological and otological status of the three groups. Preoperative and postoperative results were compared intragroup and intergroup.

Interventions

PROCEDUREcleft palate repair

restoration of tensor veli palatini for the purpose of the muscle function recovery.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 60 Months

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of cleft palate. * Primary palate repair.

Exclusion criteria

* Severe general disease * Confirmed hereditary hearing loss or neuropathic hearing loss. * Received any kind of audiological or otological therapy before. * Patients and/or his/her don't want to continue the clinical trial.

Design outcomes

Primary

Measure	Time frame	Description
Hearing level	3 months after surgery	Auditory brainstem response was tested in all three groups after surgery. The air conductive hearing threshold was used to assess the hearing level.
The otological status of middle ear	3 months after surgery	226 tympanometry was tested in all three groups after surgery. The results of 226 Hz tympanometry were classified based on Liden/Jerger classification. Four classes of tympanometry results were included.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026