- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04049058
Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context (ORTHOQOL)
November 19, 2020 updated by: University Hospital, Lille
The purpose of this study is to compare, prospectively, the quality of life of patients with cleft lip and palate before and after orthognathic surgery.
This is done through two validated questionnaires: OHIP-14 (Oral Health Impact Profile) and OQLQ (Orthognathic Quality of Life Questionnaire) Improving the quality of life is the goal of any functional treatment.
The demonstration of its improvement would validate the validity of this additional surgery for patients with cleft lip and palate.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Romain Nicot, MD
- Phone Number: +33 0320446360
- Email: romain.nicot@chru-lille.fr
Study Locations
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Lille, France
- Recruiting
- Hôpital Roger Salengro, CHU
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with cleft lip and palate with malocclusion and indication of orthognathic surgery.
Description
Inclusion Criteria:
- Man and woman ; Age: adolescents (12-17 years) and adults; Specific medical conditions: cleft lip and palate, malocclusion
- Non-opposition of the patient
- Patient willing to comply with all procedures of the study and its duration
Exclusion Criteria
- Cancellation of orthognathic surgery
- Impossibility to receive enlightened information, impossibility to participate in the totality of the study, impossibility to complete only the questionnaire
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of the OQLQ (Orthognathic Quality of Life Questionnaire) questionnaire score between the preoperative assessment and at 6 months postoperatively.
Time Frame: between the preoperative assessment and at 6 months postoperatively.
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The OQLQ questionnaire is composed of 22 items that can be rated from 0 to 4. The score varies from 0 to 88.
This questionnaire is specific to the evaluation of quality of life in relation to orthognathic surgery.
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between the preoperative assessment and at 6 months postoperatively.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of OHIP-14 questionnaire score (Oral Health Impact Profile) between preoperative evaluation and at 6 months postoperatively.
Time Frame: between the preoperative assessment and at 6 months postoperatively.
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The questionnaire is a non-specific questionnaire assessing quality of life in relation to general oral health.
It is composed of 14 questions that can be scored from 0 to 4. The score varies from 0 to 56.
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between the preoperative assessment and at 6 months postoperatively.
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Change of OQLQ (Orthognathic Quality of Life Questionnaire) by type of orthognathic surgery
Time Frame: at 6 months
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the type of orthognathic surgery performed = monomaxillary versus bimaxillary
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at 6 months
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Change of OHIP-14 (Oral Health Impact Profile) by type of orthognathic surgery
Time Frame: at 6 months
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the type of orthognathic surgery performed = monomaxillary versus bimaxillary
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at 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Romain Nicot, MD, University Hospital, Lille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2019
Primary Completion (Anticipated)
February 1, 2023
Study Completion (Anticipated)
February 1, 2023
Study Registration Dates
First Submitted
August 1, 2019
First Submitted That Met QC Criteria
August 5, 2019
First Posted (Actual)
August 7, 2019
Study Record Updates
Last Update Posted (Actual)
November 20, 2020
Last Update Submitted That Met QC Criteria
November 19, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018_55
- 2018-A03376-49 (Other Identifier: ID-RCB number, ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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