Cleft PalateNCT04366674
Mordified Restoration of Tensor Veli Palatini in Cleft Palate Repair
A study testing cleft palate repair in people with Cleft Palate, run by Peking Union Medical College Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 60 months
- Conditions the study is for
- Cleft Palate
- What is being tested?
- cleft palate repair
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of cleft palate.
- Primary palate repair.
Who cannot join
- 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.
About this study
Official title: The Possible Effect of Modified Restoration of Tensor Veli Palatini on Audiological and Otological Outcome 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.
Read the 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.
- Conditions
- Cleft Palate
- Being tested
- cleft palate repair
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cleft palate repairProcedure or surgery
restoration of tensor veli palatini for the purpose of the muscle function recovery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: cleft palate repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 to 3 months before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Jan 2013
- Primary completion31 Jan 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lian Zhou, Peking Union Medical College Hospital
- Investigators
- Lian Zhou, D.D.S, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366674
- Sponsor's protocol ID
- S-K1145
- Status last verified
- Apr 2020
- First submitted
- 26 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Effect of Modified Restoration of Tensor Veli Palatini on Audiological and Otological Outcome in Cleft Palate Repair.
- ClinicalTrials.gov ID
- NCT04366674
- Acronym / sponsor ID
- S-K1145
- Conditions
- Cleft Palate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Langerbeck's repair | Active comparator | Procedure: cleft palate repairLangerbeck'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. |
| restoration of levator veli palatini | Active comparator | Procedure: cleft palate repairThe 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. |
| mordified restoration of tensor veli palatini | Experimental | Procedure: cleft palate repairIncision 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. |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical diagnosis of cleft palate.
- Primary palate repair.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cleft palate repairrestoration of tensor veli palatini for the purpose of the muscle function recovery. | Procedure or surgery | Langerbeck's repair, mordified restoration of tensor veli palatini, restoration of levator veli palatini |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lian Zhou, D.D.S principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing cleft palate repair in people with Cleft Palate, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing level (time frame: 3 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.