Mordified Restoration of Tensor Veli Palatini in Cleft Palate Repair

NCT04366674 | Completed

• 1 other identifier: S-K1145
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cleft Palate

Outcome Measures

Primary Outcomes (4)

• Hearing level

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

  3 months after surgery

• The otological status of middle ear

  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 months after surgery

• Hearing level

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

  0 to 3 months before surgery

• The otological status of middle ear

  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.

  0 to 3 months before surgery

Study Arms (3)

Langerbeck's repair

ACTIVE COMPARATOR

Langerbeck's repair of cleft palate,without specific restoration of levator veli palatini or tensor veli palatini. Incisions along the margins of the cleft at the junction of oral and nasal mucosa. Lateral relaxing incisions were performed and the mucoperiosteal flap of hard palate were elevated on both sides except the ones with only soft palate cleft. The anterior end of the mucoperiosteal flap may be cut off for the purpose of tension relieving and would be resutured to the anterior area during closing. In the soft palate, the division was made between the oral mucous layer and the palatal musculature layer. Hamulus were broken for closing the cleft without tension. Closing was done by two seperated layers, one layer of nasal mucosa-palatal muscle, and one layer of oral mucosa.

Procedure: cleft palate repair

restoration of levator veli palatini

ACTIVE COMPARATOR

The incision was made similar to Langerbeck's repair. During disection, the levator veli palatini was identified after the elevation of flap. The levator veli palatini was separate from the oral and nasal mucosa. During closing, the anterior end of levator veli palatini was rotated towards the midline and the two muscle bundle from the two sides were sutured in the midline. In this process, the tensor veli palatini was not intentionally identified or dissected.

Procedure: cleft palate repair

mordified restoration of tensor veli palatini

EXPERIMENTAL

Incision was made similar to Langerbeck's repair. During disection, the tensor veli palatini was identified after flap elevation. Its tendinous fibers was released from but still connected to the pterygoid process without breaking the hamulus or cutting off the tendinous fibers. If the tension is too strong during suturing, the tensor tendon could be partly dissected laterally meanwhile be kept continuity medially so that the tensor veli palatini could be rotated more medially. The levator veli palatini, tensor veli palatini, together with the palatine aponeurosis and the nasal mucosa from two sides were sutured in the middle line. The tensor veli palatini may not be jointed to the contralateral one directly.

Procedure: cleft palate repair

Interventions

cleft palate repair PROCEDURE

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

Langerbeck's repair; mordified restoration of tensor veli palatini; restoration of levator veli palatini

Eligibility Criteria

• Age: 6 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

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

Study Officials

• Lian Zhou, D.D.S

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: April 29, 2020
• Study Start: January 1, 2013
• Primary Completion: January 31, 2019
• Study Completion: June 30, 2019
• Last Updated: April 29, 2020

Record last verified: 2020-04