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Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context (ORTHOQOL)

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ClinicalTrials.gov Identifier: NCT04049058
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
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.

Condition or disease
Palate, Cleft

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context
Actual Study Start Date : June 30, 2019
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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. ]
    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.


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. Change of OQLQ (Orthognathic Quality of Life Questionnaire) by type of orthognathic surgery [ Time Frame: at 6 months ]
    the type of orthognathic surgery performed = monomaxillary versus bimaxillary

  3. Change of OHIP-14 (Oral Health Impact Profile) by type of orthognathic surgery [ Time Frame: at 6 months ]
    the type of orthognathic surgery performed = monomaxillary versus bimaxillary



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cleft lip and palate with malocclusion and indication of orthognathic surgery.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049058


Contacts
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Contact: Romain Nicot, MD 0320446360 ext +33 romain.nicot@chru-lille.fr

Locations
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France
Hôpital Roger Salengro, CHU Recruiting
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Romain Nicot, MD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04049058    
Other Study ID Numbers: 2018_55
2018-A03376-49 ( Other Identifier: ID-RCB number, ANSM )
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cleft Palate
Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities