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Completed

NCT Number: NCT04366674

Mordified Restoration of Tensor Veli Palatini in Cleft Palate Repair

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.

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Key information

Conditions

Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

6 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cleft palate repair

Procedure

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

Primary outcomes

  1. Hearing level

    Time frame: 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.

  2. The otological status of middle ear

    Time frame: 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.

  3. Hearing level

    Time frame: 0 to 3 months before surgery

    Auditory brainstem response was tested in all three groups before surgery. The air conductive hearing threshold was used to assess the hearing level.

  4. The otological status of middle ear

    Time frame: 0 to 3 months before surgery

    226 tympanometry was tested in all three groups before surgery. The results of 226 Hz tympanometry were classified based on Liden/Jerger classification. Four classes of tympanometry results were included.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2020
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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